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Everest Clinical Research Services Inc

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Everest Clinical Research Services Inc Powered By Docstoc
					Capabilities and Quality Delivery System
    for Clinical Research Services


               November 2008




                                           1
   Presentation Outline


1. Company History and Overview
2. Capabilities and Services
3. Systems and Tools
4. Processes and Procedures
5. Experience and Expertise




                                  2
             Company History and Overview

• Previously, a well-established and high performing unit of Pharmacia
   Corporation, with 12 years experience in providing statistical and data
   management services.
• Became an independent Contract Research Organization (CRO) in
   January 2004 after the Pfizer acquisition of Pharmacia.
• Have been successful for 5 years operating as an independent CRO.
   Built partnership or preferred vendor relationship with a number of
   major pharmaceutical companies and other smaller pharmaceutical and
   biotech companies.
• Have a resource level of 55 full-time employees (FTEs) and
   approximately 15 part-time consultants including freelance medical
   writers.
• Corporate Headquarters is in Toronto (Markham), Canada with a
   subsidiary operation in Little Falls, New Jersey, USA.
• Promotes High Quality Standards, Customer Focused, Can-Do Spirit,
   Advanced Technologies, Continuous Improvement, and high level
   Ethical and Professional Standards.
                                                                             3
Legacy Pharmacia Statistical Operations Unit




                  • High Quality Standards
                  • Customer Focused
                  • Can-Do-Spirit
                  • Advanced Technology
                  • Continuous Improvement
                  • Ethical and Professional
     We Continue The 12-Year Legacy Built Under Pharmacia
   We Strive To Become A Center of Excellence For What We Do
                                                               4
                    Capabilities and Services

Established Core Services:
•   Biostatistics and Statistical Programming
•   Clinical Data Management, Medical Coding
•   Trial Subject Randomization using IWRS (Interactive Web-based Response System)
•   Trial Drug Dispensing and Inventory Management using IWRS
•   Development and Maintenance of Web Portals and Study Websites
•   Medical Writing for Clinical Study Reports, Abstracts, Manuscripts, Posters, etc.
•   Regulatory Submission Support Using eCTD
•   Administration of Clinical Trial Data and Safety Monitoring Boards
Other Non-Core Services:
• Clinical Trial Safety Monitoring
• Trial Management and Site Monitoring Using Partnering Clinical Management Firms


                                                                                        5
                       Functions and Structure


Finance/Accounting and                                                        Scientific and
    Legal Services                        President/CEO                    Operational Advisory



                                                                 Strategic Planning &
            HR, Training, Corporate
                                                                Business Development,
                    Affairs
                                                                 Contract Negotiation



                                             Statistical                           Network & Security,
                                                               Medical Coding,
Clinical Data         Biostatistical      Programming &                                 System
                                                              Safety Monitoring,
Management              Sciences             Database                                Administration,
                                                               Medical Writing
                                          Administration                           Web Technologies


     Regulatory Submission             Project Management &             Quality Assurance and
        Support (eCTD)                    Quality Delivery                   Compliance




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    Biostatistics and Programming Services
•    Trial design, sample size calculation, subject randomization, data
     analysis and reporting (covers phase I – IV trials)
•    Exploratory data analysis for completed trials – for publications, signal
     detection, and new trial development
•    Statistical consultation to clinical research and market support
     professionals
•    Using Study Websites within secure web portals to disseminate study
     results to authorized personnel
•    Well-designed workflow processes and procedures (SOPs in all areas of
     statistical operations), including templates for Statistical Analysis Plan,
     Statistical Analysis and Programming QC/QA Plan, Statistical Report,
     etc.
•    Following ICH, GCP, and FDA guidelines for trial design, data analysis
     and reporting
•    Using CDICS standards in preparation for statistical analyses and drug
     submissions to regulatory agencies
•    Major contributor to the writing of Clinical Study Reports, abstracts,
     manuscripts, and development of presentations and posters
                                                                                   7
    Clinical Data Management Services
•   CRF design using FrameMaker
•   Data capture and management using both Electronic Data Capture
    Systems and Paper-based System (ref to next slide)
•   Database integrity checks and trial monitoring reports within data
    management systems, and outside data management systems using
    SAS
•   Using Study Websites within secure web portals to disseminate
    database information, subject progress and trial monitoring reports
•   Medical terminology coding using MedDRA, medication coding using
    WHODRUG
•   Well-designed workflow processes and procedures (SOPs in all areas of
    data management operations), including templates for Data Management
    Plan, Database Quality Acceptance Sampling Report, Database Lock
    Checklist, etc.
•   Following ICH, GCP, and Good Clinical Data Management Practices
•   All data management systems are 21 CFR Part 11 compliant
•   All systems were validated according to Everest‟s System Validation
    Policies and SOPs wherever applicable
                                                                            8
        Main Data Management Systems

Currently we use 4 Web-based Electronic Data Capture applications:

•   InForm (Phase Forward)
•   iDataFax
•   Express (PDS)
•   Clinical Analytics (TrialStat)
    (We will use the EDC system requested by the sponsor, however our standard
    EDC systems are InForm and iDataFax)


•   We also perform data management for paper flow studies using
    the paper/fax/imaging based system DataFax.
    (This system can handle both EDC and paper CRFs within the same
    database. A trial can be completely paper based, or can use both paper/fax
    CRFs and EDC eCRFs. In this case some sites using web-based EDC data
    entry and other sites sending in paper CRFs to the data center for
    centralized data processing).

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Quality and Timely Data Collection, Cleaning, and Database Lock

 Using EDC Applications
 •   Data review, querying, and reconciliation are performed promptly as
     data is entered by the study sites. Outstanding queries are kept to a
     minimum
 •   Data review, querying, and reconciliation processes for individual
     studies are outlined in the Data Management Plans (DMP). Cleaning and
     review of the data is on-going throughout the study lifecycle up to
     database lock
 •   Database acceptance checks are performed by the internal statistical
     team during the initial data extraction test run, and the dry runs for
     interim and final analyses. This process ensures database issues are
     detected and resolved early
 •   The database can be locked within 5 working days of the last patient‟s
     last visit and receipt of last subject‟s data records, including electronic
     data transfers (central lab data, eDiaries, ECGs, other specialty labs,
     etc.)
 •   The database lock checklist is followed to ensure all steps including
     coding, medical review, SAE reconciliation, 3rd party data transfer and
     cleaning, statistical dry runs, etc. are all completed prior to locking the
     database                                                                      10
    Quality and Timely Data Collection, Cleaning, and Database Lock

Using Paper/Fax-based System

•     Electronic CRF images for the completed CRFs are accessible by authorized trial
      personnel via a secure Web Portal/Study Website
•     Data review, querying, and reconciliation are performed promptly as CRF pages
      are received. Outstanding queries are kept to a minimum
•     Data review, querying, and reconciliation processes for individual studies are
      outlined in the Data Management Plans (DMP). Cleaning and review of the data
      is on-going throughout the study lifecycle up to database lock
•     Database acceptance checks are performed by the internal statistical team
      during the initial data extraction test run, and the dry runs for interim and final
      analyses. This process ensures database issues are detected and resolved early
•     The database can be locked within 5-10 working days of the last patient‟s last
      visit and receipt of last subject‟s CRFs, including electronic data transfers
      (central lab data, eDiaries, ECGs, other specialty labs, etc.)
•     The database lock checklist is followed to ensure all steps including coding,
      medical review, SAE reconciliation, 3rd party data transfer and cleaning,
      statistical dry runs, etc. are all completed prior to locking the database

                                                                                            11
Trial Subject Randomization using IWRS

•   Statistical consultation on trial design, sample size estimation and
    justification, and subject randomization requirements and procedures
•   Development of IWRS specifications, facilitating sponsor review and
    confirmation, and obtaining authorization of the specifications
•   Design and development of IWRS database and web interface,
    implement functionalities as specified in the IWRS specifications
•   Design and development of IWRS application test plan with test scripts.
    Execution of the test plan and reporting test findings
•   Facilitating sponsor user acceptance testing and incorporating sponsor
    comments
•   Deployment of IWRS application and conducting user training using a
    parallel and independent training IWRS website, which has the same
    functionalities as implemented in the production IWRS for the trial
•   Performing IWRS application monitoring and user support
•   Ongoing data transfer to sponsor special randomization unit via a
    secure file transfer protocol


                                                                              12
Study Drug Dispensing and Management using IWRS

•   Consultation and discussion with sponsor trial team and drug supply
    personnel on drug supply and management requirements (e.g. subject
    visit and dosing requirements, drug supply flow, central and local
    depots, shipment methods, amounts on initial release and re-supply,
    handling of damaged drugs, low inventory alerts, drug supply and
    inventory monitoring reports, etc.)
•   Development of IWRS specifications, facilitating sponsor review and
    confirmation, and obtaining authorization of the specifications
•   Design and development of IWRS database and web interface for the
    drug supply and management components, in conjunction with the
    subject randomization components
•   Following the same processes and procedures as for the subject
    randomization components for application testing, user acceptance
    testing, user training, application monitoring and support
•   Ongoing data transfer to sponsor special randomization unit via a
    secure file transfer protocol


                                                                          13
          Advantages of IWRS Over IVRS
•   IWRS is more cost-effective than IVRS (eliminates the need for voice
    recording, editing, and programming)

•   Set up time for IWRS is much shorter than that for IVRS. The same is
    applicable to changes or modifications to the system

•   Visual display instructions (IWRS) has been proven to be easier to follow
    than audio instructions (IVRS) in an international clinical trial setting

•   IWRS uses simple instructions on data entry screens, which minimizes
    the need for multiple languages for IWRS applications in international
    clinical trials

•   Fewer key entry errors may occur using IWRS than using IVRS
    (computer keyboard vs. phone keypad)

•   IWRS login can be integrated within EDC systems or Study Web
    Portals/Websites



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Development and Maintenance of Trial Web Portal/Study Websites



 • Each trial sponsor may have a secure trial web portal where Study
   Websites may be built

 • Authorized trial personnel will have access to the Study Website
   for trial related information (sponsor will decide what will be made
   available in the Study Website: trial documents, trial team and site
   contact information, trial benchmarking or monitoring reports,
   etc.)

 • Perform access control, monitoring, and user support




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   Medical Writing of Clinical Study Reports and Publications


• Write Clinical Study Reports (CSR), abstracts, manuscripts, and develop
  presentations/posters
• For each trial, a medical writer with previous experience in the study
  disease area will be identified and teamed with a biostatistician, a QC peer
  reviewer, a graphic designer if necessary, and document publishing
  support personnel
• Sponsor provides CSR template, or Everest CSR template will be used
  (which was developed based on ICH CSR template)
• A CSR Shell will be developed and reviewed by internal peer reviewer.
  Sponsor comments will be obtained and incorporated before a full CSR
  will be drafted
• Facilitate review cycles of the draft CSR. Finalize CSR when all comments
  have been properly addressed
• CSR publishing procedures and final QC/QA review will be performed
  before CSR signing off


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Regulatory Submission Support Using eCTD

• To date: 14 eCTD submissions sent directly to Regulatory Agencies on
  Sponsor‟s behalf: 11 to FDA; 3 to EMEA; No agency validation
  findings/faults
• In-house submission build with options for document publishing, CDISC
  dataset preparation, SPL build, Standard Letter or A4 paper submission
  printing for Agencies or EU Member States as necessary
• Dedicated server able to send and receive documents by secure VPN
  connecting to sponsor
• SOP controlled process from start to finish. Sponsor Audited in 2007; FDA
  remote audit of documentation in July 2008 (FDA on site at Sponsor) with
  no findings/faults
• Regulatory Support for Agency communications available through
  partnering regulatory firms




                                                                              22
 Administration of Clinical Trial DSMBs


• Write Charters for clinical trial Data and Safety Monitoring Boards (DSMB)

• Identify and engage board members
• Design and develop trial data review summary tables, subject data
  listings, and graphs (TLGs)

• Generate and validate trial data review TLGs and provide them to the
  DSMB prior to the DSMB data review meetings

• Schedule and facilitate DSMB meetings, take meeting minutes (DSMB
  Secretary)

• Interact and communicate with trial sponsor and with regulatory agencies
  on behalf of the trial sponsor in accordance with the DSMB Charter




                                                                               23
              Trial Sponsors‟ Feedback


“It has been a great pleasure to work with the Everest teams.”

“They are highly motivated and always go above and beyond to
provide us with quality and timely services.”

“You are really a „Can-Do‟ team! You always try your hardest
and find solutions for problems…. your „Can-Do‟ attitude results
in continuous improvements in all of the things you do….”

“We are very impressed by everything your team has done, they
have contributed a lot to the success of the projects.”




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Therapeutic Area Expertise and Experience

         •   Oncology
         •   Hepatology
         •   Immunology/Autoimmune/Rheumatology
         •   Virology
         •   Allergy/Respiratory
         •   Infectious Diseases
         •   Nephrology
         •   Cardiovascular Diseases
         •   Endocrinology
         •   Urology
         •   Ophthalmology
         •   CNS
         •   Women‟s Health
         •   Dermatology

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         Benefits of Using Our Services

•   Due to the low overhead of the organization, quality and timely services
    can be offered at a competitive rate

•   Well-defined and streamlined processes and procedures enable
    efficiency gains and error prevention

•   Standardization in systems/tools, CRFs/eCRFs, datasets, common data
    displays, standard SAS programs, standard work templates or
    checklists, etc., enables resources/cost saving

•   Everest‟s relatively stable workforce enables knowledge and experience
    retention, minimizes the costs in hiring and initial investment in
    developing new staff members

•   Customer-focused is our tradition

•   Flexibility is our strength




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Everest Contact Information
               Irene Zhang

     Office Phone: 1- 905 – 752 - 5201
     Office Phone: 1 - 973 - 774 - 1160
     Cell Phone: 1- 416 – 788 - 8678

    Everest Corporate Website Address:
            www.ecrscorp.com

          Company Locations:

          675 Cochrane Drive
          Suite 408, East Tower
          Markham, Ontario
          Canada L3R 0B8

          150 Clove Road, Suite 502
          Little Falls, New Jersey
          USA 07424

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