Project Management for Clinical Trial Application

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					24| Adverse Events
    Clinical Project Management
    Custom Application Development
    Data Collection and Management
25| Company Directory
27| Data Mining and Visualization
    Document Management
    Electronic Data Capture (EDC)
28| Electronic Submissions
    IT Consulting
    Knowledge Management
    Medical Imaging
    Statistical Analysis
29| Training
    Trials Management and Administration
    Web-Based Software
30| Wireless/Mobile Technologies
    Other Applications
IT Solutions
                                                                                                                                PharmaTech Solutions
                                                                                                                                Services PharmaTech Solutions is a patient management
                                                                                                                                organization (PMO). We accelerate enrollment of
                                                                                                                                thoroughly qualified patients and maximize patient compli-
                                                                                                                                ance and retention. Our team understands disease
                                                                                                                                states, the challenges of enrolling a clinical trial, collabo-
 Your information technology directory                                                                                          ration with investigator sites, and our responsibility in
                                                                                                                                educating and communicating with patients.
                                                                                                                                TrialTrac, Inc.
                                                                                                                                SiteTrac See Trials Management/Administration

                                                                                                                                     Custom Application Development
The Applied Clinical Trials 2002 IT Solutions Directory presents information                                                    ArcStream Solutions
about applications used in the conduct of clinical trials. It is compiled from                                                  Services See Wireless/Mobile Technologies
information provided by application developers, and Applied Clinical Trials                                                     BBK Healthcare, Inc.
                                                                                                                       See Knowledge Management
cannot accept responsibility for the accuracy of the information they supplied.
                                                                                                                                CiteLine, Inc.
                                                                                                                                CiteLine Professional Internet See Data Mining/Visual-
                                                             Protocol Manager, our clinical trials management                   Formedix Ltd.
                  Adverse Events                             system. Automatically generates CIOMS and                          Custom software design In addition to our core clinical-
                                                             MEDWATCH 3500 reports for electronic submission.                   trials software products, Formedix also undertakes
Aris Global                                                  Uses MedDRA and/or user-defined dictionaries.                      custom software design using Java, C, C++, XML-technolo-
Aris Global E2B Gateway See Electronic Submissions           Conforms to 21 CFR part 11.                                        gies and database integration services. Our customizable
Assured Information Systems                                                                                                     paper scanning and indexing solutions have been
PV-Works PV-Works is the leading workflow-driven                                                                                integrated with handwriting-recognition and barcode-recog-
pharmacovigilance system. It is 21 CFR Part 11 compli-                Clinical Project Management                               nition systems, together with clinical laboratory informa-
ant, includes MedDRA coding and E2B. The software                                                                               tion management systems.
can inherit your own workflow processes and can be           Advanced Clinical Software
                                                             Study Manager See Trials Management/Administration
                                                                                                                                Invantage, Inc.
installed on site or run as an outsourced pharmacovigi-                                                                         Investigator DataWeb System See Trials Management/
lance service. Assured and PV-Works are able to meet         Cardio Control                                                     Administration
your pharmacovigilance system needs.                         Cardio Perfect See Medical Imaging
                                                                                                                                StudyBuilder Limited
DZS Software Solutions, Inc.                                 Clinical DataFax Systems Inc.                                      StudyBuilder Design Consultancy See IT Consulting
ClinPlus Coding See Other Applications                       DataFax See Data Collection and Management
MAJARO InfoSystems Inc.                                      ClinLogic                                                          Services Systemsmith is a Microsoft Certified Partner
ClinAccess Dictionary Coder See Data Collection/             ClinProject ClinProject is a Clinical Trials Management            focused on custom software development for clinical
Management                                                   application providing real-time insight into study progress.       trials. We have experience developing mission-critical
NetRegulus                                                   The system provides crucial information for decisions              systems for large sites, CROs, and patient recruiting
IssueExpert IssueExpert provides all the tools and           early in the study cycle before CRFs have been retrieved           firms. Our combination of clinical trials domain expertise
capabilities necessary for collecting, documenting,          and entered into clinical data management. From site initi-        and technical skill makes Systemsmith the best choice for
tracking, trending, and reporting product quality issues     ation, through grant payment disbursement, ClinProject is          all your pharmaceuticals-related custom software develop-
including adverse events, corrective and preventive          an end-to-end solution.                                            ment needs.
actions (CAPA), audits, complaints, nonconformities,         ClinSite See Trials Management/Administration                      Winchester Business Systems, Inc.
vigilance reporting, product tracking, and more. This                                                                           Custom application development Winchester Business
easy-to-use and 21 CFR Part 11-compliant module is                                                                              Systems develops software applications for pharmaceuti-
                                                             TrialXS/TMS See Trials Management/Administration
fully configurable, scalable, and secure.                                                                                       cal, biotechnology, and medical device companies
                                                             CTIS Inc.                                                          designed to improve drug and product development
StudyExpert See Trials Management/Administration
                                                             TrialBridge See Trials Management/Administration                   processes. Winchester implements systems for multi-
                                                             Cytel Software Corp.                                               site/multivendor clinical trials projects, electronic data
ES1-SafetyManager Parameterizable system for                                                                                    collection, workflow management and project manage-
                                                             EaSt See Statistical Analysis
adverse event tracking and declaration (local and inter-                                                                        ment systems, information management, and exception
national standard report forms). Standard coding dic-        DataLabs                                                           reporting for decision support.
tionaries loading available (MedDRA, WHO-DRUG, etc.).        DataLabs CTMS See Electronic Data Capture
Case report versioning included. Compliant with ICH          Datapharm Australia Pty. Ltd.
E2B and M2 for electronic submission, FDA 21 CFR             SMART SMART (Smooth Monitoring A Resource Tool) was                     Data Collection and Management
Part 11 for electronic records). Ability to query the        developed by Datapharm to assist project managers of
database.                                                    clinical trials to assess and track monitoring requirements        Acumen Healthcare Solutions, LLC
Phase Forward Incorporated                                   over several projects and to adjust estimates based on             TracIt2k EDC System See Electronic Data Capture
Clintrace The Clintrace safety tracking and reporting        actuals iteratively. It is quick to use and allows monitoring      Adapt~EDC, LLC
system offers comprehensive data management tools            of actuals vs. estimated progress milestones.                      Adapt~EDC Clinical Trials Suite See Electronic Data
that easily collect, code, and analyze adverse events,       FW Pharma Systems                                                  Capture
and helps sponsors to meet the reporting requirements        IMPACT See Trials Management/Administration
and deadlines of regulatory agencies worldwide.                                                                                 Aris Global
                                                             ICTI                                                               REGISTER REGISTER is the most comprehensive global
Relsys International                                         Interactive Trial Management Solutions ICTI provides               drug registration and tracking system. Compliant with the
Argus Safety Relsys International is the leading devel-      interactive trial management solutions using state-of-the-         latest regulatory guidelines, REGISTER provides for
oper of specialized software for managing product risk       art IVRS development tools. Applications include central-          reliable and accurate product information (e.g., preferred
associated with pharmaceuticals and medical devices.         ized patient randomization, drug supply management,                name, ingredients, International birth date, registration
The company’s software solutions empower manufac-            IVRS-based patient unblinding, patient diary data collec-          renewals formulations, approval status, registration
turers to meet current product safety regulations and        tion, accelerated patient referral, and automated informa-         number, etc), global monitoring of activities, and compli-
internal quality objectives. Argus Safety is the world’s     tion distribution. ICTI is the leader in clinical trial material   ance for manufacturing and QC regulations.
top selling global drug safety software solution.            management with the introduction of their powerful                 Cardiff Software, Inc.
Synteract                                                    forecasting and supply chain management tool.                      TELEform Cardiff TELEform streamlines collection of data
SynCoder SynCoder is a SAS application that imple-           Insightful                                                         from paper and online forms. Built-in business rules and
ments the MedDRA terminology, as well as COSTART             S+SeqTrial S+SeqTrial is an S-PLUS software library for
and WHO-DRUG dictionaries, for coding adverse event          designing, monitoring, and analyzing clinical trials using
and medication text reported during clinical trials or
post-marketing. The product requires SAS v8.1 or
                                                             group sequential methods. The main design focus is                               Wish you were here?
                                                             choosing the sample size that allows the clinical trial to
higher, and works with SAS v6 or v8 databases.               discriminate between the null and alternative hypotheses,               To list your company’s product in the
Winchester Business Systems, Inc.                            thereby answering the scientific questions of interest.                      2003 IT Solutions Directory,
adWatch adWatch helps the clinical trial team track AEs      Oriam                                                                     email your contact information to
and SAEs as well as product inquiries and complaints         EC1-TrialManager See Trials Management/Administration
from around the world. Integrates seamlessly with

24       APPLIED CLINICAL TRIALS SUPPLEMENT                                                                                                          August 2002
                                             Company Directory
                                   BioObjects, Inc.                  fax: 310-921-2835                 Bound Brook NJ 08805 USA           fax: 413-383-3543
              A–B                  345 Huelva Court                        732-764-6969             
                                   Oceanside, CA 92057 USA                  fax: 732-764-6755        
Acumen Healthcare Solutions, LLC   760-722-1792                                              
14252 23rd Avenue North                                              ClinSource                                                           Healthcare Technology Systems
                                   fax: 800-856-9554                 Mechelsesteenweg 455, Bus 2                       7617 Mineral Point Road,
Plymouth, MN 55447 USA   
763-559-8232 ext. 24                                                 Kraainem, B-1950 Belgium                                             Suite 300
                                         +32 2 766 00 80                                                      Madison, WI 53717
fax: 765-559-2821
                                                                     fax: +32 2 766 00 81
                                                                                                                     E–F                  608-827-2440
                                                                                                                                          fax: 608-827-2444                            C–D                  CTIS Inc.                         eOriginal Inc.
Adapt~EDC, LLC                                                       1355 Piccard Drive Suite 450      351 West Camden Street,
                                                                     Rockville MD 20850 USA                                     
5872 York Road                     Cardiff Software, Inc.                                              Suite 800
P Box 663                          3220 Executive Ridge Drive        301-948-3033                      Baltimore, MD 21201 USA            Honeywell/POMS
Lahaska, PA 18931 USA              Vista, CA 92083 USA               fax: 301-948-2242                 410-659-9796                       13655 Dulles Technology Drive
215-794-5691                       760-936-4500                              fax: 410-659-9799                  Herndon, VA 20171 USA
fax: 215-794-5691                  fax: 760-936-4800                              703-793-4400                        Cytel Software Corp.                      fax: 703-793-4401                            675 Massachusetts Avenue                                   
Adobe Systems Inc.                 Cardio Control                    Cambridge, MA 02139 USA           39 High Gate Lane
                                   Mercuriusweg 1                    617-661-2011                      Blue Bell, PA 19422 USA
345 Park Avenue
                                   Delft, 2624 BC, The Netherlands   fax: 617-661-4405                 215-643-3318
San Jose, CA 95110 USA
408-536-6000                       +31 15 750 5000                             fax: 509-692-4939                  ICTI
fax: 408-537-6000                  fax: +31 15 750 5050                          1040 Stony Hill Road,                       Datafarm Inc.                       Suite 200
                                      275 Boston Post Road, Suite 2     etrials, Inc.                      Yardley, PA 19067 USA
Advanced Clinical Software
212 4th Avenue                     Carevoyance Telematics            Marlborough, MA 01752 USA         2701 Aerial Center Parkway,        267-685-4284
Seattle, WA 98121-2025 USA         1228 Hamilton Street Suite 503    508-624-6454                      Suite 100                          fax: 267-685-4262
206-728-0313                       Vancouver, BC V6B 2S8 Canada      fax: 508-624-0848                 Morrisville NC 27560 USA 
fax: 206-728-0469                  604-642-2273                          919-653-2000                             fax: 604-642-2293                      fax: 919-653-2001                  iMedRIS Data Corp.               DataLabs                                   36213 Highland Avenue, Yucaipa
                                        17310 Redhill Avenue,                       CA 92399 USA
Advanced Systems
Development                        CB Technologies, Inc.             Suite 200                         First Consulting Group             909-520-9164
1650 Borel Place, Suite 209        350 Eagleview Boulevard           Irvine, CA 92614 USA              575 E. Swedesford Road,            fax: 909-520-0031
San Mateo, CA 94402 USA            Exton, PA 19341-1155 USA 610-     949-851-2030                      Suite 200                
650-292-5314                       280-7400                          fax: 949-851-2043                 Wayne, PA 19087 USA      
fax: 650-292-5302                  fax: 610-280-0440                        610-989-7000                       InferMed Limited                                 fax: 610-989-7100                  23 Bedford Square                              Datapharm Australia Pty. Ltd.               London, WC1B 3HH UK
                                   Cetan Technologies                56-56A Thompson Street                 +44 20 7269 3715
305 Cotton Bay Way                 4106 Shipyard Boulevard           Drummoyne, NSW 2047               Fisher Clinical Services           fax: +44 20 7269 3716
Simpsonville, SC 29681 USA         Wilmington, NC 28403 USA 910-     Australia                         7554 Schantz Road        
864-284-9918                       452-2253                          +612 9719 2800                    Allentown, PA 18106 USA                       fax: 910-452-2355                 fax: +612 9719 2811               610-391-0800                       InfoPro Solutions
                                      fax: 610-391-0801
Analyse-it Software, Ltd.                                                                                                                 31200 Via Colinas, Suite 102
P Box 103
 .O.                                                                                                                                      Westlake Village, CA
                                   CiteLine, Inc.                    DataSpectrum                 91362-3953 USA
Leeds, LS27 7WZ UK
+44 113 210 0708                   1608 Merlot Court, 2nd Floor      6131 Falls of Neuse Road,         Formedix Ltd.                      818-879-0075
fax: +44 113 229 8424              Petaluma, CA 94954 USA            Suite 200                         1 Ainslie Road, Hillington         fax: 818-879-7303                888-436-3012                      Raleigh, NC 27609 USA             Glasgow G52 4RU UK                 info@infoprosolutions                 fax: 707-762-0666                 888-255-5300                      +44 141 585 6434         
                                          fax: +44 141 585 630
ArcStream Solutions                                                                                                                       Insightful
                                               35 Corporate Drive, Fourth Floor
311 Arsenal Street                                                                                                                        1700 Westlake Avenue North,
                                   Clinical DataFax Systems Inc.     DATATRAK International, Inc.      Burlington, MA 01803               Suite 500
Watertown, MA 02472 USA                                                                                781-685-4995
617-393-2400                       21 King Street West, Suite 305    6150 Parkland Boulevard,                                             Seattle WA 98109 USA
                                   Hamilton, ON L8P 4W7 Canada       Suite 100                         fax: 781-685-4601                  fax: 206-283-8802                                                                                             905-522-3282                      Mayfield Heights, OH 44124                                           fax: 206-283-8691
                                   fax: 905-522-7284                 USA                              
Aris Global                                440-443-0082                      FW Pharma Systems        
2777 Summer Street                          fax: 216-921-6702                 Four Brindleyplace
Stamford, CT 06905 USA                                                                                                                    IntraLinks, Inc.
                                                                      Birmingham, B1 2JB UK
203-588-3000                       ClinicalTrialsNet Inc.                                                                                 1372 Broadway
                                                                          +44 121 616 5616
fax: 203-356-1673                  12 John Street                                                                                         New York, NY 10018 USA
                                   Charleston SC 29403 USA           DATATRAK Deutschland, GmbH        fax: +44 121 616 5601              212- 543-7700                                                                                      843-965-5598                      Am Propsthof 80                                                      fax: 212-543-7801
                                   fax: 843-965-5849                 53121 Bonn, Germany              
Assured Information Systems        +49 228 979 8330                                           
Equity House, 18 Market Square         fax: +49 228 979 8334
St. Neots, Cambs PE19 2AF UK                                                       G–H                   Invantage, Inc.
+44 1 480 21 22 23                 Clinitrac                                                                                              201 Broadway, #601
fax: +44 1 480 21 64 95            St. Eriksgatan 113                                                  Galt Associates, Inc.              Cambridge, MA 02139 USA                 Stockholm, S-113 43 Sweden        Drumbeat Dimensions, Inc.         46040 Center Oak Plaza,            617-577-7844                  +46 8 5088 0600                    .O.
                                                                     P Box 100                         Suite 100                          fax: 617-249-0844
                                   fax: +46 8 5088 0609              West Mystic, CT 06388-0100        Sterling, VA 20166 USA   
BBK Healthcare, Inc.                     USA                               703-433-6104             
320 Needham Street, Suite 150                 860-572-7255            
Newton MA 02464 USA                                                                                                                       invivodata, inc.
                                                                     fax: 860-536-9419       
617-630-4477                       ClinLogic                                                                                              5615 Scotts Valley Drive,
fax: 617-630-5090                  18436 Hawthorne Boulevard                                           Gupta Programming                  Suite 150
                                                                         Suite 208                                                           213 Goldenwood Circle              Scotts Valley, CA 95066 USA              Torrance, CA 90504 USA            DZS Software Solutions, Inc.      Simi Valley, CA 93065 USA          831-438-9550
                                   310-921-6025                      1661 Route 22 West                805-577-8877                       fax: 831-440-1770

August 2002                                                                                   APPLIED CLINICAL TRIALS SUPPLEMENT                 25                            617-868-6878                          fax: 901-680-0140                    TEAMworks Clinical Services                                                         fax: 617-868-2654                          6 Stirling House, Stirling Road
                                                                                   Stat-Ease, Inc.                      The Surrey Research Park
                                                    O–P                                     2021 East Hennepin Avenue,           Guildford Surrey GU2 7RF UK
               K–L                                                          Premier Research/                     Suite 480                            +44 1483 510360
                                       Oriam                                                                                                           fax: +44 1483 302 528
                                                                            SCP Communications                    Minneapolis, MN 55413 USA
 KIKA Medical                          U.S.                                                                                                  
                                                                            30 South 17th Street                  612-378-9449
 15 Rue du Géneral Drouot              100 Cummings Center,                                                                                  
                                                                            Philadelphia, PA 19103 USA            fax: 612-378-2152
 Nancy, 54000 France                   Suite 311 H
                                                                            215-282-5500                                    TrialTrac, Inc.
 +33 3 83 30 40 31                     Beverly, MA 01915 USA
                                                                            fax: 215-636-9726                                45 Main Street, Suite 405
 fax: +33 3 83 35 22 08      
                                                                                    StudyBuilder Limited                 Brooklyn, NY 11021 USA   
                                                                                John Eccles House                    718-237-4000                   Europe:
                                                                            ProIRB Plus, Inc.                     Robert Robinson Avenue               fax: 718-237-4688
 LifeTree Technology, LLC              8 Parvis de St-Maur, Saint-Maur,                                                                      
                                                                            6020 44th Avenue North                The Oxford Science Park,
 41093 County Center Drive             94106 France                                                                                          
                                                                            St. Petersburg FL 33709 USA           OX4 4GP UK
 Temecula, CA 92591 USA                +33 1 55 97 03 20
                                                                            727-545-5314                          +44 1865 338 092
 800-843-7477                          fax: +33 1 55 97 03 22
                                                                            fax: 727-541-2433                     fax: +44 1865 338 100
 fax: 800- 418-4333          
                                                                                                     Perceptive Informatics                                                                                          Validation Wizards
                                                                            Propack Data Corp.                    SyMetric Sciences, Inc.              International
 Liquent, Inc.                         200 West Street
                                                                            2000 Regency Parkway,                 1-2082 Sherbrooke West                .O.
                                                                                                                                                       P Box 100
 1300 Virginia Drive Suite 125         Waltham, MA 02451 USA
                                                                            Suite 375                             Montreal, QC H3H 1G5 Canada          West Mystic, CT 06388-0100
 Fort Washington, PA 19034 USA         781-487-9900
                                                                            Cary, NC 27511 USA                    514-935-4562                         USA
 800-515-3777                          fax: 781-434-5916
                                                                            919-465-1741                          fax: 514-935-9911                    860-572-7255
 fax: 215-654-7724           
                                                                            fax: 919-465-1742                               fax: 860-536-9419            
                                                                                                      PerMedics, Inc.                              Symfo                      
 Logos Technologies Ltd.               1475 South Victoria Court
                                                                                                                  632 Massachusetts Avenue,            Velos, Inc.
 Chiltern House, Feathers Yard         San Bernardino, CA 92408 USA
                                                                                                                  Suite 401                            2201 Walnut Avenue,
 Basingstoke Hampshire RG21            877-4PERMED                                        Q–R                     Cambridge, MA 02139                  Suite 208
 7AT UK                                fax: 909-478-5016
                                                                                                                  866-88-SYMFO                         Fremont, CA 94538 USA
 +44 1256 478900                                Relsys International
 fax: +44 1256 473332                            16267 Laguna Canyon Road                                                 Irvine, CA 92618 USA                  Synergy Software                     fax: 510-739-4018
                                       PharmaTech Solutions                                                                                                                                    949-453-1715                          2457 Perkiomen Avenue
                                       3534 South College Road,                                                                              
                                                                            fax: 949-453-1817                     Reading, PA 19606 USA
                                       Suite I
                                                                                         610-779-0522                         Vitalograph Ltd.
                                       Wilmington, NC 28412 USA 910-
              M–N                      395-5674                                           fax: 610-370-0548                    Maids Moreton
                                                                                                                             Buckingham, Bucks
                                       fax: 910-392-7275                    Resampling Stats, Inc.
 MAJARO InfoSystems Inc.                                                                                                      MK18 1SW UK
                                      612 North Jackson Street
 1731 Technology Drive,                                                                                                                                +44 1280 827120
                                       Arlington, VA 22201 USA               Synteract
 Suite 560                                                                                                                                             fax: +44 1280 823302
                                                                            703-522-2713                          187 Calle Magdalena
 San Jose, CA 95110 USA                Pharsight Corporation                                                                                 
                                                                            fax: 703-522-5846                     Encinitas, CA 92024 USA
 408-562-1890                          800 West El Camino Real,                                                                              
 fax: 408-562-1899                     Suite 200
                                                                                        fax: 760-634-2170                       Mountain View, CA 94040 USA                              S–T
                                       fax: 650-314-3810
 Mini Mitter Co.
                                                                                           S–T                    Systemsmith                          Wimmer Systems, LLC
 20300 Empire Avenue,
                                                                                       18436 Hawthorne Boulevard,           3008 Cochise Drive
 Building B-3                                                               SEC Associates, Inc.
                                                                                                                  Suite 208                            Independence, MO 64057 USA
 Bend, OR 97701 USA                    Phase Forward                        3900 Paramount Parkway,
                                                                                                                  Torrance, CA 90504 USA               816-795-5177
 800-685-2999                          Incorporated                         Suite 150 South
                                                                                                                  310-921-2735                         fax: 816-795-5177
 fax: 541-322-7277                     1440 Main Street                     Morrisville, NC 27560 USA
                                                                                                                  fax: 310-921-2835                               Waltham, MA 02451 USA                919-467-1997
                                                                                                                                   888-703-1122                         fax: 919-467-1109
                                       fax: 781-890-4848                                                               Winchester Business Systems, Inc.
                                                    Target Health                        50 Cross Street
 One Tower Lane Suite 1700
                                                                                    261 Madison Avenue, 24th Floor       Winchester, MA 01890 USA
 Oakbrook Terrace IL 60181 USA                                              SiteWorks Solutions
                                                                                                                  New York, NY 10016 USA               781-729-7150
 888-707-6900                          PPD Informatics                      6409 Quail Hollow Road
                                                                                                                  212-681-2100                         fax: 781-729-7211
 fax: 630-573-6050                     84 Sherman Street                    Memphis,TN 38120
                                                                                                                                  Cambridge, MA 02140 USA              888-707-SITE(7483)

intuitive validation processes quickly capture accurate         DZS Software Solutions, Inc.                                  MAJARO InfoSystems Inc.
information. Operators spend seconds verifying data             ClinPlus Data Management DZS Software Solutions is            ClinAccess Dictionary Coder SAS-powered. Integrates
rather than minutes manually keying entire forms.               the leader in SAS-based software solutions for Clinical       with ClinAccess or as standalone. Works with any diction-
Connects to leading clinical database applications, includ-     Data Management and Reporting. The ClinPlus family of         ary, including MedDRA, COSTART, WHO, or custom built.
ing SAS, SPSS, Oracle Clinical, and Clintrial.                  products enable your company to meet its goals in a           Autoencodes exact matches. Flexible term search, learn-
Clinical DataFax Systems Inc.                                   timely and cost effective manner.                             ing capabilities, entered word as replacement, etc. to
DataFax A complete clinical trials management solution          etrials, Inc.                                                 assist with uncoded terms. Variety of reports. Used with
using CRFs and simple fax technology at the clinical sites      QuickStudy etrials, Inc. provides data management             entire system, images dynamically appear for easy coding.
and powerful software at the coordinating center including:     technologies and services for the healthcare industry.        NetRegulus
intelligent character recognition from faxed CRFs, query        etrials offers efficient data management products and         IssueExpert See Adverse Events
tracking, standard reports, audit trails, study setup tool,     services for collecting, monitoring and assessing quantita-
bookmarked PDFs of patient CRFs, acceptance test kit,
                                                                                                                              RegistryExpert RegistryExpert allows users to link and
                                                                tive and qualitative study data. etrials leads biotech and    track products, patients, care facilities, capital equipment,
and much more.                                                  pharmaceutical companies through the critical processes       medical professionals, and more. Register and track
ClinSource                                                      involved in successfully migrating from paper-based to        capital equipment and products by product number,
TrialXS/CRF See Electronic Data Capture                         electronic data capture methods.                              serial/lot number, date or your own system. Features
DataSpectrum                                                    Formedix Ltd.                                                 multiple address capability to quickly locate patients with
Services DataSpectrum is a data and statistical services        Formedix Origin, Formedix Transform, and Formedix             products in critical situations.
provider. DataSpectrum’s “no barriers” approach                 Express See Electronic Data Capture                           PerMedics, Inc.
integrates all data capture methods—Internet, paper and         Healthcare Technology Systems                                 Surveyor See Trials Management/Administration
fax—into one validated system. This “mix and match”             Clinical IVRS See Electronic Data Capture
capability gives you the flexibility to pick a study site
                                                                                                                              Pharsight Corporation
based on patient enrollment and site quality—not the
                                                                InferMed Limited                                              Pharsight Knowledgebase Server Collaborative data
site’s technological capability.
                                                                MACRO See Electronic Data Capture                             management for 21 CFR Part 11 compliance.

26       APPLIED CLINICAL TRIALS SUPPLEMENT                                                                                                       August 2002
Phase Forward Incorporated                                      patient diaries, online data submissions, and data report-    ously monitoring for adverse events and assuring trial
InForm See Electronic Data Capture                              ing.                                                          protocol adherence. Better quality data, reduced time to
                                                                QuickZilver See Web-Based Software Services                   database lock, and safe management of adverse events
InForm Architect Phase Forward’s powerful InForm Archi-                                                                       results in significantly reduced risk for our customers.
tect development tool quickly designs, tests, validates         Cardiff Software, Inc.
and documents Web-based clinical trials.                        TELEform See Data Collection and Management                   CB Technologies, Inc.
                                                                Drumbeat Dimensions, Inc.                                     MetaTrial CB Technologies is the premier provider of
PPD Informatics                                                                                                               technology tools and services to the life science indus-
TableTrans A data transformation tool.                          Dynamic DRUMBEAT for Clinical Trials Supplies (CTS)
                                                                Dynamic DRUMBEAT for Clinical Trial Supplies provides the     tries. CB’s solutions include MetaTrial clinical electronic
SyMetric Sciences, Inc.                                         basic DRUMBEAT Tools for assessing compliance, linking        data capture software and myMetaTrial Management
SyMetric Clinical Data Management System Comprehen-             policies and procedures to DRUMBEAT Concepts and              Portal. These innovative solutions enable greater efficien-
sive data management system for clinical trials including       worldwide regulations, and assessing the quality of your      cies in the clinical trials process. For more MetaTrial infor-
full support for double data entry, multivariate data valida-   documents and your level of compliance.                       mation, visit
tion, data dictionary, autoencoders for all standard dictio-                                                                  ClinicalTrialsNet Inc.
naries (ICD9, MedDRA, WHO, etc.), query management,             eOriginal Inc.
                                                                eOriginal eCore Business Suite 2.0 eOriginal Inc. is the      ClinTriNet ClinicalTrialsNet has developed a Web-based
flexible export to ASCII, HTML, and SAS, etc. Complies                                                                        system that enables comprehensive data and project
with all regulatory requirements. For more information,         leading provider of enterprise software to enable organiza-
                                                                tions to execute secure online business transactions          management in a regulatory compliant, on-line environ-
please visit our Web site.                                                                                                    ment. Our intuitive user interface makes it easier for you
                                                                creating legally enforceable electronic original documents.
Vitalograph Ltd.                                                By leveraging the eOriginal eCore Business Suite 2.0,         to focus on trial management, instead of trial software
Spirotrac Centralized Spirometry System See Electronic          companies are able to participate in end-to-end electronic    management. Contact us to bring efficient technology to
Data Capture                                                    transactions, dramatically reducing paperwork costs,          your trials!
Wimmer Systems, LLC                                             increasing profit margins and accelerating contract cycles.   Clinitrac
DaCS (Data Compliance System) DaCS is the original              First Consulting Group                                        Clinitrac Patient Diary Wireless patient diary for collec-
stand-alone 21 CFR 11 compliance solution for Microsoft         FirstDoc CRFs FCG has combined the industry’s best            tion and monitoring of patient data in real time.
Excel, providing security, audit trails, and true electronic    practices, state-of-the-art technology, and consulting        ClinSource
signatures in a low-cost, low-overhead, and customizable        services to produce FirstDoc CRF, the industry’s only         TrialXS/CRF TrialXS/CRF is a Web-enabled CRF design
solution. Free demonstration software allows you to             Documentum-based, prepackaged electronic document             tool to create, design, program and change Clinical
conduct a full evaluation before purchasing.                    management solution for case report forms (CRFs). Our         Research Forms in a fast, accurate, remote and secure
Winchester Business Systems, Inc.                               solution addresses highly complex document manage-            environment. It works fully integrated with the TrialXS trial
paraFILE paraFILE helps users capture, author, edit,            ment and regulatory requirements associated with CRFs.        management and data capture system.
review, approve, and publish electronic documents from          IntraLinks, Inc.                                              DataLabs
any computer source or application. paraFILE fosters an         IntraLinks digital workspaces IntraLinks digital              DataLabs CTMS DataLabs CTMS is the first Internet-
environment where document creation, review, and                workspaces enable pharmaceutical companies to collabo-        based product that integrates the elements of project,
approval is collaborative among authors, approvers, and         rate efficiently with external parties to organize and        data and document management into a single application.
reviewers within and outside the corporation. 21 CFR Part       complete work faster and better. Using IntraLinks             Based in Microsoft’s .NET framework and servers, this
11 compliant.                                                   workspaces, which are 21 CFR Part 11 compliant, profes-       integrated approach provides significant benefits, includ-
                                                                sionals securely exchange documents, conduct discus-          ing an accelerated time to market, lower development
                                                                sions, and manage information online. Pharmaceutical          costs and improved research quality.
        Data Mining and Visualization                           companies speed complex, critical activities such as drug     Datapharm Australia Pty. Ltd.
                                                                development and licensing while saving on communica-
CiteLine, Inc.                                                  tion, document distribution, and meeting costs.
                                                                                                                              eCRF eCRF is a remote data capture tool allowing sites to
CiteLine Professional Internet Editorially supported appli-                                                                   send clinical trial data electronically to Datapharm’s
cation featuring parallel searching, site monitoring, and       Liquent, Inc.                                                 secure server. Fields are programmed with edit checks
“hide my identity.” Utilized by thousands of industry           CoreDossier See Knowledge Management                          and database lookups allowing quick access to clean data
knowledge workers to maximize the value of the Web for          MAJARO InfoSystems Inc.                                       which can be viewed on the Web. System setup and
their business information needs. Includes information          ClinAccess PowerServer See Data Collection and                maintenance is cost effective.
on competitor clinical trials, epidemiology, disease,           Management                                                    DATATRAK International
medical economics, regulatory, and more.                                                                                      DATATRAK EDC DATATRAK International, Inc., with offices
                                                                Pharsight Corporation
Insightful                                                      PKS Reporter Template-driven authoring of compound            in Cleveland, Ohio, and Bonn, Germany, specializes in
Insightful Miner Insightful Miner Desktop Edition is the        documents and reports.                                        electronic data capture using DATATRAK EDC. The product
first affordable, no-compromise data mining workbench                                                                         suite operates in centralized or stand-alone modes, and
that gives new data miners and skilled modelers the             Winchester Business Systems, Inc.                             offers state-of-the-art security and real-time data entry and
ability to deploy predictive intelligence throughout the        paraLAB-Electronic LABOOK paraLAB-Electronic LABOOK           review. Electronic site assessment and Web-based train-
enterprise.                                                     is a document repository meant to augment and/or              ing are offered.
                                                                replace the paper data notebook used by scientists and
NetRegulus                                                      engineers. paraLAB can contain documents that manage          DZS Software Solutions, Inc.
ReportExpert ReportExpert provides detailed, Web-               files from practically any computer source.                   ClinPlus Remote See Web-Based Software Services
enabled internal analytical reporting for decision makers,                                                                    etrials, Inc.
as well as regulatory reporting for all phases of a                                                                           QuickStudy See Data Collection and Management
product’s life cycle. Includes a library of standard reports           Electronic Data Capture (EDC)
and intuitive tools to create unlimited ad hoc reports.                                                                       Formedix Ltd.
Generates and e-mails regularly scheduled reports. Pulls                                                                      Formedix Origin, Formedix Transform, and Formedix
                                                                Acumen Healthcare Solutions, LLC
data from related and nonrelated database sources,                                                                            Express Formedix Origin is our standards-based trial
                                                                TracIt2k EDC System TracIt2k is the most affordable and
regardless of platform.                                                                                                       authoring package that allows the specification of a
                                                                flexible EDC solution available today. Quickly and easily
                                                                                                                              complete clinical trial, including the efficient re-use of
Phase Forward Incorporated                                      create, design and modify your own e-CRFs complete with
                                                                                                                              previous trial components. Formedix Transform is our
Clintrial See Data Collection and Management                    error checks and comprehensive audit trails. If you need a
                                                                                                                              automated trial generation service, quickly and safely
                                                                system to accommodate off-line and/or on-line data entry
Synergy Software                                                without changing your database, TracIt2k can do it afford-
                                                                                                                              transforming Origin-based specifications into working
KaleidaGraph KaleidaGraph is an easy-to-use 2D graphing                                                                       trials. The result is Formedix Express, a real-time
and data analysis application for scientists. Easily                                                                          electronic data capture and collaboration solution that is
customize every aspect of your plot, perform flexible           Adapt~EDC, LLC                                                powerful, flexible and easy to use. Seamless
regression analysis and add error bars. Perform basic           Adapt~EDC Clinical Trials Suite Adapt~EDC serves the          scanning/integration of paper-based materials with
statistics on your data including t-test. Print your graph or   pharmaceutical and biotechnology industries by develop-       electronic trial records. Also: custom software services.
export to PowerPoint, the Web, and other favorite applica-      ing and supporting advanced software applications and
                                                                outsourcing services designed to dramatically reduce the
                                                                                                                              FW Pharma Systems
tions.                                                                                                                        INITIATOR See Trials Management/Administration
                                                                costs and time associated with the collection, distribution
                                                                and analysis of clinical trial data. Adapt~EDC enables        Healthcare Technology Systems
             Document Management                                companies to make go/no-go decisions much earlier than        Clinical IVRS Healthcare Technology Systems (HTS) is the
                                                                ever before possible.                                         world leader in developing and providing clinical interactive
Adobe Systems Inc.                                                                                                            goice response systems (IVRS) to gather data directly
                                                                Cardiff Software, Inc.
Adobe Acrobat Acrobat 5.0 software lets you convert any                                                                       from patients. HTS offers more than 30 IVR clinical rating
                                                                LiquidOffice The Cardiff LiquidOffice eForm Management
document to an Adobe Portable Document Format (PDF)                                                                           scales, including the HAMD, plus research and clinical
                                                                System is a complete XML-based solution that is used to
file. Anyone can open your document across a broad                                                                            expertise.
                                                                automate forms and the business processes they drive.
range of hardware and software, and it will look exactly as     LiquidOffice uses XML, HTML and PDF standards to put          InferMed Limited
you intended. Distribute documents with complete visual         forms into an online system—complete with routing,            MACRO MACRO is a modular system for running Internet-
fidelity via print, the Web or mobile devices.                  online approval, digital signatures and data processing.      based multicenter trials. MACRO’s intuitive, interactive
AlQemy                                                                                                                        tools for remote study definition, on-line and off-line
                                                                Carevoyance Telematics
PDF Form Services Design and deployment services for                                                                          remote data entry and remote study monitoring reduce
                                                                Catalyst Using the RIM BlackBerry 957, Catalyst collects,
electronic forms (PDF) used for secure data collection—                                                                       set-up time and improve time to database closure.
                                                                analyzes, and transmits data in real time, while continu-

August 2002                                                                                             APPLIED CLINICAL TRIALS SUPPLEMENT                     27
MACRO is the only independent EDC system fully                     With offices in Switzerland, UK, Germany, Singapore, and       requires between 40 and 160 hours of consultancy.
integrated with Oracle Clinical.                                   USA, TEAMworks is also establishing itself as a global         Systemsmith
invivodata, inc.                                                   leader in applying innovative Internet technologies            Services See Custom Application Development
invivosystem The invivosystem is a patient-focused                 together with high performance processes to automation
electronic diary solution for collecting real-time, real-world     of the clinical trial process.
patient self-report data for clinical research that is valid,      Vitalograph Ltd.                                                           Knowledge Management
reliable, and timely. By combining behavioral science              Spirotrac Centralized Spirometry System Vitalograph has
methods and proven Web and handheld technologies, the              been a world leader in respiratory diagnostics for almost      Aris Global
invivodata patient management system consistently deliv-           40 years. The Centralized Spirometry System transmits          REGISTER See Data Collection and Management
ers patient compliance at unmatched levels.                        encrypted data everyday via email from investigator sites      BBK Healthcare, Inc.
LifeTree Technology, LLC                                           direct to the sponsor or via a dedicated and unique over- TrialCentralNet is BBK’s e-process
LifeTree ICTM LifeTree ICTM is a comprehensive Internet-           read software system where data quality is ensured on a        management system for maximizing site enrollment
based solution that accelerates trials, setting the                daily basis.                                                   capability through the creation of relationships with clini-
standard for trial data management. ICTM's Web-based               Wimmer Systems, LLC                                            cal study sites. The comprehensive suite of Web-based
system simplifies study design and data management,                DaCS (Data Compliance System) See Data Collection              tools includes modules specific to sponsors, sites and
automates electronic case report forms (eCRFs) and                 and Management                                                 BBK. Providing ongoing data and communications access
accelerates data entry and validation. ICTM answers the                                                                           in real-time, TrialCentralNet creates a “virtual community”
demand for exceptional data management.                                                                                           among key parties and maximizes productivity.
Logos Technologies Ltd.                                                         Electronic Submissions                            BioObjects, Inc.
ALPHADAS Logos Technologies is one of the early                                                                                   Web Services See Web-Based Software Services
                                                                   Aris Global
pioneers of electronic data capture for drug research.                                                                            Insightful
                                                                   Aris Global E2B Gateway E2B Gateway is the only
ALPHADAS and Smart Patient Diary Card use Internet,                                                                               InFact InFact is currently the only commercial technology
                                                                   electronic safety submissions software certified by
smart card, and hand-held technologies, providing high-                                                                           of its kind to embody human-like intelligence, thereby
                                                                   Cyclone Commerce to operate with the EMEA. Designed
quality and regulatory-compliant solutions. Additionally,                                                                         empowering knowledge workers and decision-makers to
                                                                   as a stand-alone application, E2B Gateway facilitates the
recruitment, study scheduling, laboratory and data                                                                                make better decisions faster in a wide range of critical,
                                                                   transfer and management of E2B/M2 files to regulatory
management tools provide both sponsor and site with a                                                                             high-value business areas.
                                                                   authorities and trading partners. E2B Gateway can be
fully integrated solution.
                                                                   configured to work with ANY pharmacovigilance system.          Liquent, Inc.
MAJARO InfoSystems Inc.                                            Cardiff Software, Inc.                                         CoreDossier CoreDossier lets you easily and efficiently
ClinAccess SureStart See Data Collection and Manage-                                                                              manage multiple, simultaneous report and submission
                                                                   LiquidOffice See Electronic Data Capture
ment                                                                                                                              dossiers. The backbone of this product suite is its unpar-
                                                                   Datafarm Inc.
Mini Mitter Co.                                                    Clinical Information Technology Consulting Datafarm
                                                                                                                                  alleled PDF-rendering technology, which ensures that exact
Actiwatch Actigraphy Monitors Actiwatches are wrist-                                                                              page fidelity is maintained at all times. With a single,
                                                                   provides electronic document publishing, clinical data         cohesive interface, it works with no modification on most
worn, 17.5-g medical devices for monitoring subject activ-
                                                                   management, statistical analysis and reporting, document       document management systems.
ity and analyzing sleep and circadian rhythm patterns.
                                                                   management systems and custom application develop-
Used for supplementing patient diaries with objective                                                                             NetRegulus
                                                                   ment solutions. Functionally, Datafarm solutions maximize
data, verifying subject compliance with trials protocol, and                                                                      PQIntelligence PQIntelligence is a 21 CFR Part 11-compli-
                                                                   the quality of publishing and efficiency of document life-
tracking treatment efficacy. Actiwatch-Score includes an                                                                          ant software suite that provides enterprise-wide, Web-
                                                                   cycle management.
LED touchpad for patient input of subjective rating on pain                                                                       enabled data management specifically for the medical
levels, anxiety, etc.                                              eOriginal Inc.                                                 products industry. Working in the background, PQIntelli-
                                                                   eOriginal eCore Business Suite 2.0 See Document
NetRegulus                                                         Management
                                                                                                                                  gence organizes, automates, and manages clinical,
ActivityExpert ActivityExpert is an entirely Web-based                                                                            regulatory, and other product quality data, while you focus
solution that enables any authorized person to input infor-        Galt Associates, Inc.                                          on what you do best—developing and marketing your
mation into NetRegulus’ PQIntelligence Software System.            dsGateway and dsNavigator dsGateway: Proven online             product.
This product is ideal for vendors, field representatives,          secure electronic submission. dsNavigator: The industry        Premier Research/SCP Communications
auditors, clinical trial personnel, and others who require         standard coding and dictionary management solution             Premier Web Portal The Premier Web Portal is a protocol-
limited access to the system’s functionality. Available in         Gupta Programming                                              specific Web page that is a password-protected central
both online and offline versions for increased productivity        Best Practices Clinical Trial Reporting Templates              repository of all study information and CRFs for your study.
and mobility.                                                      Expedite and standardize new development based on pre-         Why does this technology make a difference to you? (1)
Phase Forward Incorporated                                         built and validated best practices clinical trial reporting    Because it’s Web based, CRF data can be viewed on a
InForm Phase Forward’s flagship solution is the InForm             templates. Reuse and customize best practices templates        real-time basis. (2) Because it’s Web based, sponsors and
software product, using Internet technologies for                  to individual clinical trial studies. Ideal environment for    investigators can access all or parts of study-related infor-
electronic data capture (EDC) to conduct and manage                leveraging and reusing existing SAS code. Ensure compli-       mation (e.g., subject status and study documents)
clinical trials efficiently and effectively. The InForm            ance by using best practices SOP and validation documen-       whenever they choose. (3) Pre-screening data on an
solution covers all operational functions of a clinical data       tation for IQ and OQ requirements.                             ongoing basis saves CRAs valuable time during site visits
management system in a user-friendly, Web browser-                 MAJARO InfoSystems Inc.                                        while allowing sponsors to make protocol revisions as
based interface that puts all information just a click away.       ClinAccess Web See Data Collection and Management              necessary.
StudyBuilder Limited
StudyBuilder Enterprise Edition ($4999/study designer;                                                                                              Medical Imaging
no site/subject/data manager fees) Integrated study                                    IT Consulting
design, data management and collection software                                                                                   Cardio Control
package. Use wizards and drag-and-drop to design and               Advanced Systems Development
                                                                   Clinical IT systems implementation consulting                  Cardio Perfect PC-based resting ECG system. Includes
deploy your study. Includes data collection/management                                                                            management of data. Optional software for digital trans-
system for Web, palmtop, and desktop computers and                 Implementation and integration consulting services for
                                                                   Oracle Clinical, TMS, AERS and other IT clinical systems.      mission, Interpretive statements, QT/JT dispersion, HRV.
integrates data from spirometers, etc. automatically.                                                                             Will have FDA-XML output once defined by FDA.
Symfo                                                              Cetan Technologies
                                                                   Computer Systems Validation Consulting Services See            KIKA Medical
Symfo Electronic Diary Electronic handheld patient                                                                                Eventa See Web-Based Software Services
diaries for recording symptoms, activities, medication             Validation
intake, etc.                                                       Datafarm Inc.                                                  Perceptive Informatics
                                                                                                                                  Services See IT Consulting
Target Health Inc.                                                 Clinical Information Technology Consulting See                                              Statistical Analysis
Target e*CRF Target e*CRF is a proprietary Internet-based          Electronic Submissions
remote data entry, data management and project manage-             Perceptive Informatics                                                         Statistical Analysis
ment system, created and managed exclusively by Target             Services Perceptive Informatics, Inc. develops and offers
Health Inc. Data are entered through a Web interface               a portfolio of sophisticated and innovative technology-        Analyse-it Software, Ltd.
(browser) directly to a remote database. No software is            based products and services that facilitate clinical product   Analyse-it Clinical Laboratory Analyse-it! Method valida-
installed ,and the system is fully functional even if used         development and decrease time to peak sales. The               tion and evaluation software for Microsoft Excel. Includes
with a 28.8 modem.                                                 technology portfolio includes Web-based solutions, Inter-      NCCLS and IFCC protocols, Altman-Bland and NCCLS bias-
TEAMworks Clinical Services                                        active voice response systems, electronic data capture,        plots, Deming, Passing-Bablok and Kappa method
TRIALink EDC Systems TEAMworks was founded in 1997                 and medical imaging solutions.                                 comparisons, NCCLS EP5 imprecision, NCCLS EP6 linear-
following successful introduction of our Internet-based            StudyBuilder Limited                                           ity, IFCC reference ranges, ROC curves, and sensitivity
TRIALink electronic data capture (EDC) system. The                 StudyBuilder Design Consultancy Outsource study design         and specificity analysis. Visit our Web site to download a
TEAMworks organization has since established itself as a           and implementation based on StudyBuilder products to           free trial.
leading EDC innovator and vendor with experience in the            our consultants including protocol and paper case report       ClinSource
implementation, deployment and support of e-clinical               form design (includes layout, development of validation        TrialXS/PDR TrialXS/PDR is the Online Patient Data
trials across all phases and international geographies.            criteria, documentation and testing). Typical project          Review application for reporting and exporting Clinical Trial
                                                                                                                                  Data, containing statistical tools and automated data

28       APPLIED CLINICAL TRIALS SUPPLEMENT                                                                                                           August 2002
verification. It is an online data review application for fast,   ClinSite ClinSite is a comprehensive solution for SMOs           application providing productivity and compliance assur-
accurate and secure handling of your study data.                  and research sites, managing all aspects of clinical trial       ance tools for managing the institutional review board
TrialXS/PDR is designed to speed up the data review               participation from prospecting and enrollment to grant           work-flow process from scheduling to meeting minutes.
process in your clinical trials.                                  payments and patient stipends. The system tracks visits          The application is developed in MS Access and is
Cytel Software Corp.                                              and procedures and can enforce protocol visit windows.           currently in use by major universities and healthcare insti-
EaSt Software for the flexible design of clinical trials,         ClinSite also includes call center management, media             tutions nationwide.
including early stopping, midstream sample size adjust-           effectiveness, and medical records.                              Propack Data Corp.
ment, and interim monitoring.                                     ClinSource                                                       PMX CTM Solution The CTM solution fulfills the specific
DataSpectrum                                                      TrialXS/TMS TrialXS/TMS is the integrated Web-based              requirements of the pharmaceutical industry. CTM stands
Services See Data Collection and Management                       Trial Management System For Your Clinical Research               for the organization of the complete material and informa-
                                                                  Community. To plan, conduct and effectively manage clini-        tion flow: the production of the substances, randomiza-
DZS Software Solutions, Inc.                                      cal trials through experience, collaboration, and consis-        tion, packaging to the delivery, batch tracing and surveil-
ClinPlus NDA DZS Software Solutions is the leader in              tent workflow. The TrialXS Trial Management System (TMS)         lance of the expiry and retest date of the trial samples at
SAS-based software solutions for Clinical Data Manage-            addresses the global management aspects of the entire            the clinical centers.
ment and Reporting. The ClinPlus family of products               clinical research process.
enable your company to meet its goals in a timely and                                                                              SiteWorks Solutions
cost effective manner.                                            CTIS Inc.                                                        SiteMinder Web-based financial, regulatory and adminis-
                                                                  TrialBridge Clinical trials research and management              trative management application. Fully integrated, config-
Gupta Programming                                                 solution.                                                        urable system including budgeting, financial tracking,
Best Practices Clinical Trial Reporting Templates See                                                                              regulatory administration and patient scheduling and
Electronic Submissions                                            FW Pharma Systems
                                                                  IMPACT IMPACT is a comprehensive, single, integrated
MAJARO InfoSystems Inc.                                           database for managing clinical research activities, ranging      TrialMinder Web-based trial management application
ClinAccess Web See Data Collection and Management                 in scale from single-site to large multinational, multisite      designed for study and financial management, site activa-
Pharsight Corporation                                             studies. It provides a route to a wealth of management           tion, and document tracking. Provides investigator registry
Pharsight Trial Simulator Simulation-based clinical trial         control techniques such as control by key performance            information, investigator payment tracking, document
design and optimization.                                          indicators.                                                      tracking, regulatory management, budgeting, and report-
                                                                                                                                   ing capabilities.
Resampling Stats, Inc.                                            ICTI
Resampling Stats Software Resampling Stats uses the               Interactive Trial Management Solutions See Clinical              StudyBuilder Limited
new statistics of resampling (including bootstrapping and         Project Management                                               Complete Introduction to StudyBuilder Training Course
permutation). Resampling is excellent for confidence inter-                                                                        See Training
                                                                  iMedRIS Data Corp.
vals, hypothesis tests, and assessing errors in estimates         Study Assistant iMedRis has designed a Web-based trials          TrialTrac, Inc.
used to determine reliability of conclusions drawn from           management system that integrates with our Web-based             SiteTrac SiteTrac is clinical trials management software
small samples. Resampling Stats’ easy-to-use program-             IRB application. Submissions, AEs, and updates all flow          tailored to the needs of SMOs, research institutions,
ming language lets you design resampling procedures with          seamlessly between each of the modules thus cutting              sites, and AROs. It’s easy to use, quick to implement, and
your data.                                                        time and paperwork for all. Sites also have ability to           customizable. Our integrated design is comprehensive,
Stat-Ease, Inc.                                                   capture and export data using our new Data Capture               and tracking includes patient information, essential
Design-Ease Software Design-Ease is an entry-level                module.                                                          documents, investigator earnings and sponsor payments,
program for design and analysis of two-level factorial                                                                             patient/study searching, and every step in between.
                                                                  InfoPro Solutions
screening experiments. Detect main effects and interac-           Clinicopia Suite The Clinicopia Suite is the world’s first       Velos, Inc.
tions that lead to breakthrough improvements. In addition,        purpose-built, industry-specific clinical trials supplies        Velos eResearch Velos eResearch is a transformational
the software handles any number of categorical factors at         management system developed from the ground up to                trial management solution that supports investigators,
any number of levels, thus offering extreme flexibility for       meet the unique needs and concerns of all the groups             study teams and sponsors through the entire research
most screening needs.                                             associated with clinical trial materials supply. The Suite       process—including protocol design, patient feasibility
Synergy Software                                                  consists of Clinicopia Supply Chain, Clinicopia Labeling,        assessment, study administration, project management
KaleidaGraph See Data Mining/Visualization                        and Clinicopia Forecasting.                                      and trial execution—-thus expediting the research
                                                                                                                                   process, enhancing quality and improving access to data
                                                                  Invantage, Inc.
                                                                                                                                   by integrating systems, aggregating information and
                                                                  Investigator DataWeb System Invantage’s Investigator
                         Training                                 Dataweb is a unified Web-based repository and decision
                                                                                                                                   centralizing processes.
                                                                  support environment for corporatewide collaboration and          Winchester Business Systems, Inc.
ePharmaLearning                                                   proprietary knowledge management regarding large                 Protocol Manager Protocol Manager is a software suite
eMeetings, eLearning On-line meetings, eLearning and              numbers of potential investigators. Using a personalized         that helps an entire trial team (sponsor, CRO, SMO, site,
eCollaboration solutions for clinical research profession-        Web interface, sponsors access and analyze potential             investigator, and CRA) manage all documents for clinical
als delivered by clinical research professionals.                 investigator data, producing highly informed and confident       trials—all investigator documents, protocol documents,
StudyBuilder Limited                                              decisions regarding effective trial placement.                   inventory, SOPs, patient recruiting, patient scheduling and
Complete Introduction to StudyBuilder Training Course                                                                              patient tracking. It includes a Snapshot module that
Complete Introduction to StudyBuilder Training Course                                                                              details summary trial status. 21 CFR Part 11 compliant.
                                                                  StudyExpert StudyExpert streamlines the management of
($499/CD-ROM, DVD, video) An interactive multimedia               clinical trial and other study data, while complying with the
guide to using StudyBuilder tools for study design, data          FDA’s Guidance for Industry: Computerized Systems Used
collection and management.                                        in Clinical Trials and 21 CFR Part 11. Features intuitive
Validation Wizards International                                  tools to enter, track, verify, query, view and export case
                                                                                                                                   Cetan Technologies
Validation Wizard for Application User Teams See Valida-          report from data as well as input and oversee key
                                                                                                                                   Computer systems validation consulting services Cetan
tion                                                              management information.
                                                                                                                                   provides specialized computer systems validation (CSV)
                                                                  Oriam                                                            services for the pharmaceutical, biotechnology, and
                                                                  EC1-TrialManager Administrative, financial clinical trials       medical device industries. Our test suites are designed to
 Trials Management and Administration                             management, including tracking of milestones, essential          determine the accuracy and reliability of each computer
                                                                  documents, drug supplies, sites, patient visits and proce-       system function using a practical, defensible approach.
Advanced Clinical Software                                        dures, budgeting and payments. Integration of SOPs               We also specialize in 21 CFR Part 11 assessments, SOP
Study Manager Study Manager makes the process of                  (check-list module). Off-line modules (portable and              development and remediation.
conducting studies more efficient, more organized, and
                                                                  wireless). Database query (query module). Web-enable
more profitable. It lets research administrators manage                                                                            Drumbeat Dimensions, Inc.
                                                                  (site and patient levels). Standard API (planning, IVRS,
operations and financials, while making daily work easier                                                                          Dynamic DRUMBEAT for Clinical Trials Supplies (CTS)
                                                                  data management, finances, logistics, etc.). Audit trail (21
and more organized for clinical staff. Now entirely Web-                                                                           See Document Management
                                                                  CFR compliant).
based, Study Manager is in its ninth year, with over 1200                                                                          Honeywell/POMS
installations worldwide.                                          PerMedics, Inc.                                                  POMS CMS See Other Applications
                                                                  Surveyor Surveyor is a software application designed
Advanced Systems Development                                      specifically for single- and multisite clinical trials manage-   SEC Associates, Inc.
Clinical IT systems implementation consulting See IT              ment. Surveyor tracks trial progress including enrollments,      Computer system compliance consulting SEC Associates
Consulting                                                                                                                         provides system compliance consulting and computer
                                                                  scheduling, resource management, financials and IRB
Analyse-it Software, Ltd.                                         tracking. Patient tracking tools include automated               validation services for the pharmaceutical, biotechnology,
Analyse-it Clinical Laboratory See Statistical Analysis           scheduling, screening, adverse events and activity               and medical device industries. SEC’s experienced consul-
                                                                  reports. The Web-based software aids HIPAA compliance            tants assist clients with regulatory compliance assess-
Assured Information Systems                                                                                                        ments, vendor audits, 21 CFR 11 training, procedure
PV-Works See Adverse Events                                       and simplifies trial management.
                                                                                                                                   development, requirements analysis and planning,
ClinicalTrialsNet Inc.                                            PharmaTech Solutions                                             documentation, and execution of computer validation and
ClinTriNet See Electronic Data Capture                            Services See Clinical Project Management                         life cycle activities.
ClinLogic                                                         ProIRB Plus, Inc.                                                Validation Wizards International
ClinProject See Clinical Project Management                       PRO_IRB PRO_IRB is a multi-User, multi-IRB software              Validation Wizard for Application User Teams Validation

August 2002                                                                                                  APPLIED CLINICAL TRIALS SUPPLEMENT                   29
Wizard for Application User Teams is a “read-and-click”          iMedRIS Data Corp.
application that trains the trainer and the user team in the     Study Assistant See Trials Management/Administration                       Other Applications
ABCs of computer systems validation (CSV) for user
acceptance of regulated systems. Wizard teaches a
                                                                 KIKA Medical                                               CB Technologies, Inc.
common-sense approach for integrating CSV into the
                                                                 Eventa Eventa technology allows the development of         MetaTrial See Electronic Data Capture
                                                                 customized Web-based applications dedicated to the
normal workflow of regulated areas.                                                                                         DZS Software Solutions, Inc.
                                                                 management of studies and registries.
                                                                                                                            ClinPlus Coding DZS Software Solutions is the leader in
                                                                 LifeTree Technology, LLC                                   SAS-based software solutions for Clinical Data Manage-
               Web-Based Software                                LifeTree ICTM See Electronic Data Capture                  ment and Reporting. The ClinPlus family of products
                                                                 Logos Technologies Ltd.                                    enables your company to meet its goals in a timely and
AlQemy                                                                                                                      cost effective manner.
                                                                 ALPHADAS See Electronic Data Capture
QuickZilver Innovative Web-based process modeling
software utilized for improved organization and ISO certifi-     Premier Research/SCP Communications                        Fisher Clinical Services
cation and documentation.                                        Premier Web Portal See Knowledge Management                Clinical Materials Supply Chain Management Services
                                                                                                                            Services include design, manufacturing, packaging, label-
PDF Form Services See Document Management                        Propack Data Corp.                                         ing, storage, distribution, site management including
                                                                 PMX CTM Solution See Trials Management/Administra-
BioObjects, Inc.                                                                                                            patient randomization and kit assignment, return process-
                                                                 tion                                                       ing and drug destruction. We utilize the latest technology
Web Services BioObjects specializes in enterprise
business and data solutions. This includes: portal design        SiteWorks Solutions                                        within cGMP facilities managing your projects with experi-
and development using Web services; data integration;            SiteMinder See Trials Management/Administration            enced teams.
e-procurement and supply chain managements; and                  TrialMinder See Trials Management/Administration           Honeywell/POMS
staffing and workforce management.                                                                                          POMS CMS Manufacturing execution systems for clinical
                                                                 StudyBuilder Limited
DZS Software Solutions, Inc.                                     StudyBuilder Enterprise Edition See Electronic Data        supplies manufacturing.
ClinPlus Remote DZS Software Solutions is the leader in          Capture                                                    SEC Associates, Inc.
SAS-based software solutions for Clinical Data Manage-                                                                      Computer system compliance consulting See Validation
ment and Reporting. The ClinPlus family of products              Velos, Inc.
enable your company to meet its goals in a timely and            Velos eResearch See Trials Management/Administration       Synergy Software
cost effective manner.                                                                                                      KaleidaGraph VersaTerm-Pro is a broad-based communi-
                                                                                                                            cations application combining high-quality, industry
ePharmaLearning                                                         Wireless/Mobile Technologies                        standard terminal emulations and a suite of network
eMeetings, eLearning See Training                                                                                           connections. Terminal emulations include: DEC
Galt Associates, Inc.                                            ArcStream Solutions                                        VT100/VT220, Data General’s D210/D211, both with
dsGateway and dsNavigator See Electronic Submissions             Services ArcStream is a wireless and mobile systems        multiple sessions.
                                                                 integration firm focused on developing solutions for the
Insightful                                                       mobile professional.
                                                                                                                            Winchester Business Systems, Inc.
StatServer StatServer is a Web-based decision support                                                                       Health Agency Tracking The Health Agency Tracking
system based on S-PLUS, the premier tool for data analy-         Carevoyance Telematics                                     system tracks all documents associated with queries and
sis, data mining, and statistical modeling. It enables           Catalyst See Electronic Data Capture                       responses made by and to regulatory agencies. Automatic
analysts to deploy analytical tools to decision makers who       Logos Technologies Ltd.                                    workflow notifies all interested parties and initiates action
can then run shared analytical models, view custom               SMART Patient Diary Card See Electronic Data Capture       items for resolution of the query. Maintains complete
reports, and generate graphics from a familiar environ-                                                                     audit trail. Conforms to 21 CFR Part 11 regulations for
ment, such as a Web browser or Excel.                            NetRegulus                                                 electonic records and signatures.
                                                                 ActivityExpert See Electronic Data Capture
IntraLinks, Inc.
IntraLinks digital workspaces See Document Mgmt.

Looking Ahead

                                                                                                 For more information contact:
                         The 2003 Applied Clinical Trials                                         Wayne K. Blow
                         EDC & Software Application                                               Raritan Plaza III, 101 Fieldcrest Avenue, Edison, NJ
                         Supplement will be polybagged                                            08837-3622, USA
                                                                                                  +1 (732) 346-3021 fax: +1 (732) 225-0211
            with the March 2003 issue, to be
                                                                                                  Gillian Brailsford
            distributed at the DIA’s 18th Annual                                                  EUROPEAN SALES MANAGER
            Workshop for Clinical Data                                                            Advanstar House, Park West, Sealand Road, Chester
                                                                                                  CH1 4RN, UK
            Management, March 30–April 2, 2003,                                                   +44 (1244) 393 104 fax: +44 (1244) 376 130

            Philadelphia Marriott Hotel,                                                          John Kiesewetter
            Philadelphia, Pennsylvania.                                                           WESTERN SALES MANAGER
                                                                                                  859 Willamette Street, Eugene,
                                                                                                  OR 97401-6806, USA
                                                                                                  +1 (541) 338-0022 fax: +1 (541) 338-0044

30       APPLIED CLINICAL TRIALS SUPPLEMENT                                                                                                     August 2002

Description: Project Management for Clinical Trial Application document sample