24| Adverse Events
Clinical Project Management
Custom Application Development
Data Collection and Management
25| Company Directory
27| Data Mining and Visualization
Electronic Data Capture (EDC)
28| Electronic Submissions
Trials Management and Administration
30| Wireless/Mobile Technologies
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.
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.
TrialCentral.net See Knowledge Management
cannot accept responsibility for the accuracy of the information they supplied.
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
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
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 actmagazine.com August 2002
BioObjects, Inc. fax: 310-921-2835 Bound Brook NJ 08805 USA fax: 413-383-3543
A–B 345 Huelva Court firstname.lastname@example.org 732-764-6969 email@example.com
Oceanside, CA 92057 USA www.clinlogic.com fax: 732-764-6755 www.guptaprogramming.com
Acumen Healthcare Solutions, LLC 760-722-1792 firstname.lastname@example.org
14252 23rd Avenue North ClinSource Healthcare Technology Systems
fax: 800-856-9554 Mechelsesteenweg 455, Bus 2 clinplus.com 7617 Mineral Point Road,
Plymouth, MN 55447 USA email@example.com
763-559-8232 ext. 24 Kraainem, B-1950 Belgium Suite 300
www.bioobjects.com +32 2 766 00 80 Madison, WI 53717
fax: +32 2 766 00 81
acumenhealthcare.com C–D CTIS Inc. eOriginal Inc.
Adapt~EDC, LLC 1355 Piccard Drive Suite 450 351 West Camden Street,
Rockville MD 20850 USA www.healthtechsys.com
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 firstname.lastname@example.org fax: 410-659-9799 Herndon, VA 20171 USA
fax: 215-794-5691 fax: 760-936-4800 www.ctisinc.com email@example.com 703-793-4400
firstname.lastname@example.org email@example.com Cytel Software Corp. www.eoriginal.com fax: 703-793-4401
www.adaptedc.com www.cardiff.com 675 Massachusetts Avenue www.poms.com
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 firstname.lastname@example.org fax: 509-692-4939 ICTI
fax: 408-537-6000 fax: +31 15 750 5050 www.cytel.com email@example.com 1040 Stony Hill Road,
www.adobe.com firstname.lastname@example.org Datafarm Inc. www.epharmalearning.com Suite 200
www.cardiocontrol.com 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 email@example.com
fax: 206-728-0469 604-642-2273 firstname.lastname@example.org 919-653-2000 www.icti-usa.com
email@example.com fax: 604-642-2293 www.datafarminc.com fax: 919-653-2001 iMedRIS Data Corp.
www.ClinicalSoftware.net firstname.lastname@example.org DataLabs email@example.com 36213 Highland Avenue, Yucaipa
www.carevoyance.com 17310 Redhill Avenue, www.etrials.com CA 92399 USA
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 Sales@imedris.com
650-292-5314 280-7400 fax: 949-851-2043 Wayne, PA 19087 USA www.iMedRIS.com
fax: 650-292-5302 fax: 610-280-0440 firstname.lastname@example.org 610-989-7000 InferMed Limited
email@example.com firstname.lastname@example.org www.datalabs.com fax: 610-989-7100 23 Bedford Square
www.advasys.com www.cbtech.com Datapharm Australia Pty. Ltd. email@example.com London, WC1B 3HH UK
Cetan Technologies 56-56A Thompson Street lifesciences.fcg.com +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 firstname.lastname@example.org
864-284-9918 452-2253 +612 9719 2800 Allentown, PA 18106 USA www.infermed.com
www.alQemy.com fax: 910-452-2355 fax: +612 9719 2811 610-391-0800 InfoPro Solutions
email@example.com firstname.lastname@example.org fax: 610-391-0801
Analyse-it Software, Ltd. 31200 Via Colinas, Suite 102
cetantechnologies.com www.datapharm.com.au email@example.com
P Box 103
.O. Westlake Village, CA
CiteLine, Inc. DataSpectrum www.fisherclinicalservices.com 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
firstname.lastname@example.org 888-436-3012 Raleigh, NC 27609 USA Glasgow G52 4RU UK info@infoprosolutions
www.analyse-it.com fax: 707-762-0666 888-255-5300 +44 141 585 6434 www.infoprosolutions.com
email@example.com firstname.lastname@example.org fax: +44 141 585 630
ArcStream Solutions Insightful
www.citeline.com www.dataspectrum.com 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
www.arcstream.com 905-522-3282 Mayfield Heights, OH 44124 fax: 206-283-8691
fax: 905-522-7284 USA www.formedix.com email@example.com
Aris Global firstname.lastname@example.org 440-443-0082 FW Pharma Systems www.insightful.com
2777 Summer Street www.datafax.com fax: 216-921-6702 Four Brindleyplace
Stamford, CT 06905 USA IntraLinks, Inc.
email@example.com Birmingham, B1 2JB UK
203-588-3000 ClinicalTrialsNet Inc. 1372 Broadway
www.datatraknet.com +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
www.arisglobal.com 843-965-5598 Am Propsthof 80 fax: 212-543-7801
fax: 843-965-5849 53121 Bonn, Germany www.fwpharma.com firstname.lastname@example.org
Assured Information Systems email@example.com +49 228 979 8330 www.intralinks.com
Equity House, 18 Market Square www.clinicaltrialsnet.com fax: +49 228 979 8334
St. Neots, Cambs PE19 2AF UK firstname.lastname@example.org 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
email@example.com Stockholm, S-113 43 Sweden Drumbeat Dimensions, Inc. 46040 Center Oak Plaza, 617-577-7844
www.assured.co.uk +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 firstname.lastname@example.org
BBK Healthcare, Inc. email@example.com USA 703-433-6104 www.invantage.com
320 Needham Street, Suite 150 www.clinitrac.com 860-572-7255 firstname.lastname@example.org
Newton MA 02464 USA invivodata, inc.
fax: 860-536-9419 www.DrugSafety.com
617-630-4477 ClinLogic 5615 Scotts Valley Drive,
fax: 617-630-5090 18436 Hawthorne Boulevard Gupta Programming Suite 150
email@example.com Suite 208 213 Goldenwood Circle Scotts Valley, CA 95066 USA
www.bbkhealthcare.com 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 actmagazine.com APPLIED CLINICAL TRIALS SUPPLEMENT 25
firstname.lastname@example.org www.netregulus.com 617-868-6878 fax: 901-680-0140 TEAMworks Clinical Services
www.invivodata.com fax: 617-868-2654 siteworkssolutions.com 6 Stirling House, Stirling Road
email@example.com Stat-Ease, Inc. The Surrey Research Park
O–P www.ppdi.com 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. firstname.lastname@example.org
30 South 17th Street 612-378-9449
15 Rue du Géneral Drouot 100 Cummings Center, www.teamworks.de
Philadelphia, PA 19103 USA fax: 612-378-2152
Nancy, 54000 France Suite 311 H
215-282-5500 email@example.com TrialTrac, Inc.
+33 3 83 30 40 31 Beverly, MA 01915 USA
fax: 215-636-9726 www.statease.com 45 Main Street, Suite 405
fax: +33 3 83 35 22 08 firstname.lastname@example.org
email@example.com StudyBuilder Limited Brooklyn, NY 11021 USA
www.premier-research.com John Eccles House 718-237-4000
ProIRB Plus, Inc. Robert Robinson Avenue fax: 718-237-4688
LifeTree Technology, LLC 8 Parvis de St-Maur, Saint-Maur, firstname.lastname@example.org
6020 44th Avenue North The Oxford Science Park,
41093 County Center Drive 94106 France www.trialtrac.com
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 email@example.com
www.lifetree-tech.com 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 firstname.lastname@example.org
fax: 919-465-1742 email@example.com fax: 860-536-9419
firstname.lastname@example.org www.symetric.ca Tim_Fields@drumkey.com
www.liquent.com PerMedics, Inc. www.propack-data.com Symfo www.drumkey.com
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 email@example.com Relsys International
fax: +44 1256 473332 www.permedics.com 16267 Laguna Canyon Road
firstname.lastname@example.org Irvine, CA 92618 USA Synergy Software fax: 510-739-4018
PharmaTech Solutions email@example.com
www.logostechnologies.com 949-453-1715 2457 Perkiomen Avenue
3534 South College Road, www.veloseresearch.com
fax: 949-453-1817 Reading, PA 19606 USA
firstname.lastname@example.org 610-779-0522 Vitalograph Ltd.
Wilmington, NC 28412 USA 910-
M–N 395-5674 www.relsys.net fax: 610-370-0548 Maids Moreton
email@example.com Buckingham, Bucks
fax: 910-392-7275 Resampling Stats, Inc.
MAJARO InfoSystems Inc. www.synergy.com MK18 1SW UK
firstname.lastname@example.org 612 North Jackson Street
1731 Technology Drive, +44 1280 827120
www.pharmatechsolutions.com Arlington, VA 22201 USA Synteract
Suite 560 fax: +44 1280 823302
703-522-2713 187 Calle Magdalena
San Jose, CA 95110 USA Pharsight Corporation email@example.com
fax: 703-522-5846 Encinitas, CA 92024 USA
408-562-1890 800 West El Camino Real, www.vitalograph.co.uk
fax: 408-562-1899 Suite 200
www.resample.com fax: 760-634-2170
firstname.lastname@example.org Mountain View, CA 94040 USA S–T
Mini Mitter Co.
S–T Systemsmith Wimmer Systems, LLC
20300 Empire Avenue,
www.pharsight.com 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 email@example.com
firstname.lastname@example.org Waltham, MA 02451 USA 919-467-1997
www.minimitter.com 888-703-1122 fax: 919-467-1109
fax: 781-890-4848 email@example.com Winchester Business Systems, Inc.
firstname.lastname@example.org www.secassociates.com Target Health 50 Cross Street
One Tower Lane Suite 1700
www.phaseforward.com 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
email@example.com 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
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 actmagazine.com 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 www.metatrial.com.
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
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
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 actmagazine.com 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- TrialCentral.net 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
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-
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-
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
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 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 actmagazine.com 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-
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.
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
by integrating systems, aggregating information and
Investigator DataWeb System Invantage’s Investigator
Training Dataweb is a unified Web-based repository and decision
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
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
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 actmagazine.com 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
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 digital workspaces See Document Mgmt.
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
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 actmagazine.com August 2002