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Practical considerations for eTMF Planning


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Life science companies expect electronic trial master file (eTMF) projects to provide greater efficiency, improve quality, increase standardization and enhance collaboration in TMF management. Join Paragon Solutions for the second session of our TMF webinar series to gain insights on the practical factors to consider when planning a new or improved future state eTMF. We'll share industry data on eTMF drivers, and discuss our definition of a robust eTMF. You'll learn why TMF information architecture is so critical to eTMF uptake and usability, and high level considerations for systems integration/migration. Finally, we'll define the maturity framework that allows for assessment of eTMF organizational readiness, a critical baseline to successful future state eTMF planning.

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Practical considerations for eTMF Planning

  1. 1. Practical Considerations foreTMF PlanningIndustry WebinarFebruary 13, 2013Fran Ross, Principal Consultant, Paragon SolutionsMichael Agard, Senior Consultant, Paragon Solutions Paragon Solutions, Inc. Proprietary and Confidential
  2. 2. Agenda Introductions Why the move to robust eTMF ? People, process, technology requirements Insight on eTMF maturity model Paragon Solutions, Inc. Proprietary and Confidential -2-
  3. 3. Paragon Solutions’ Introduction Paragon is an enterprise information management solutions company that helps firms leverage information assets to achieve better business Corporate Facts results.• Privately owned, 30-year history• Professional Services and Solutions Divisions• US-Based, NJ Headquarters - 8 domestic and international offices - Overseas development center• Dual-shore Delivery Paragon Solutions, Inc. Proprietary and Confidential -3-
  4. 4. Practical Considerations for eTMF PlanningDoes your electronic trial master file (eTMF) … …provide greater efficiency? …improve quality? …increase standardization? …enhance collaboration? Paragon Solutions, Inc. Proprietary and Confidential -4-
  5. 5. Practical Considerations for eTMF PlanningWhat factors drive the move to a robust eTMF? Paragon Solutions, Inc. Proprietary and Confidential -5-
  6. 6. TMF Paper to Electronic Evolution Paper TMF Repository eTMF Trial Enabler• Paper based, localized TMFs • Centralized, global electronic TMFs• Myriad interpretations of requirements • Leverages TMF Reference Model• Multiple copy / master record confusion • Sole authoritative artifacts• Document “graveyard” • Active workflows to support study conduct• No integration with master metadata • Robust metadata for search and retrieval• Closed / locked environment • Open secure access• Repetitive, error prone process • Automated workflows support CT process• Manual Retention & Litigation Holds • Coordinated, automated RM processes• Significant scramble for audit/inspection • Continuous readiness for audit/inspection Paragon Solutions, Inc. Proprietary and Confidential -6-
  7. 7. Polling Question #1Where are you on the eTMF continuum? a. No eTMF b. Electronic repository only c. Active eTMF, without full trial enablement d. Fully robust eTMF Paragon Solutions, Inc. Proprietary and Confidential -7-
  8. 8. eTMF status What is the status of your organizations eTMF? We currently use eTMF 13% 3% 28% Actively Building / 10% Implementing Evaluating 19% Actively Planning 27% Not Considering Unknown/Not Applicable From TMF Reference Model working group
  9. 9. eTMF Systems Evolution Knowledge Asset Tool e-Filing • Workflows support CT processes (IP Release) Cabinet • Smart alerts, actionable reports • Shares master CT data (CTMS, EDC, IRT) • Curated collection of email, NTF, correspondence eTMFs on Seamless TechnologiesSeparate Sys. • Internal and partner eTMF in concert Electronic SmartDocs Scanned • Created, processed, filed electronically • Digital signatures, fillable forms Documents • Prepopulated with applicable data Balanced Document Access Restricted • Appropriate permissions, secure content Access • All sponsor, site, vendor and inspector roles Paragon Solutions, Inc. Proprietary and Confidential -9-Confidential – Proprietary to Paragon 9
  10. 10. Ready for a Truly Robust eTMF? Robust eTMF is not a technology problem, it’s a people and process opportunity Reliance on current process must be abandoned • Paper is not required, ink signatures are not needed, document tracking tools are irrelevant • Creators must be responsible for their content Perceptions of GCP “requirements” have to be challenged Both users and stakeholders buy into new business as usual Paragon Solutions, Inc. Proprietary and Confidential - 10 -
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  13. 13. Critical Factors When Embarking Organizational readiness assessment: involve all players • Clinical, Ext team, Quality, IT, all others in trial landscape Change Management communications from the start • Why will this change, WIIFM? Clear-eyed view of the landscape • Critical programs, partnership/outsourcing, competitive programs, IT roadmaps Thorough grasp of the Information Architecture • Clearly defined content (TMF RM) w/definitions and responsibilities • Metadata, data flow, migration, integration Paragon Solutions, Inc. Proprietary and Confidential - 13 -
  14. 14. Metadata is required for eTMF flow Reduce keystrokes to create new study, country, site • Automate entry of trial personnel, roles and contact details Enable user-friendly navigation and search Manage access and control by role, status or content type Relate content collection to trial milestones Reduce process complexity of related documents • Protocol amendments, informed consent Support in-flight Investigator changes • Trigger collection of new CV, 1572, Financial Disclosure Automate signals for clinical trial process via workflows • Investigational Product release Robust eTMF flow critically relies on authoritative and accurate metadata Paragon Solutions, Inc. Proprietary and Confidential - 14 -
  15. 15. Clinical System Interfaces Planning Study Conduct Reports / Submissions IxRS LMS / Access Training Management Project Submission Submission CTMS eTMFPlanning Repository Publishing EDC Templates or Structured Authoring Safety / PV Paragon Solutions, Inc. Proprietary and Confidential - 15 -
  16. 16. eTMF Navigation Paragon Solutions, Inc. Proprietary and Confidential - 16 -
  17. 17. Polling Question #2What is the biggest impediment to using CTMS data in eTMF? a. Data not collected early enough in the process b. Data quality and accuracy c. Lack of data warehouse or extraction abilities d. Lack of expertise for interface / integration e. Issues in sharing data between sponsor and CRO Paragon Solutions, Inc. Proprietary and Confidential - 17 -
  18. 18. CTMS & TMF Data For Navigation Paragon Solutions, Inc. Proprietary and Confidential - 18 -
  19. 19. CTMS & TMF Data in file names Paragon Solutions, Inc. Proprietary and Confidential - 19 -
  20. 20. CTMS Search Paragon Solutions, Inc. Proprietary and Confidential - 20 -
  21. 21. TMF Search Data Paragon Solutions, Inc. Proprietary and Confidential - 21 -
  22. 22. eTMF Implementation Teams Steering Committee IT Project Business Management Architecture & Interface & TMF Ref. Model / Communication & Compliance, SOPs, Access & Security Process Environments Configuration Index Training Templates Yellow Study Migration & boxes are ImplementationDecommissioning Plan key for initial planning Paragon Solutions, Inc. Proprietary and Confidential - 22 -
  23. 23. Additional factors / risk areas to addressPeople • Access management • Vendor Management / Consulting Services • Support services, HelpDesk, Technology TransferProcess • Content flow for Regulatory Submissions • Electronic and digital signatures, workflows People • Safety document managementTechnology Process • CTMS Interface and data extraction and quality • Platform integration / Cloud services • Global performance Technology Paragon Solutions, Inc. Proprietary and Confidential - 23 -
  24. 24. eTMF Maturity ModelArchive eTMF Active eTMF Integrated eTMF• Electronic archive of • eTMF drives business • Process and user TMF documents processes integration with site• Easier access for • Business users rely on for full electronic business users eTMF for all content submission / review• Standardized TMF needs • Inspection readiness structure and • Structure flexibility for embedded in all management trial requirements eTMF user behaviors• Centralized • Improvements driven by • Process-driven trial management and central metrics milestone completion maintenance • Doc. mgmt . DURING • Full integration with• Well managed, AFTER business process (i.e., IP internal systems document completes Release Authorization) • All documents signed business process • Clin. Systems integration electronically (digital• Minimal transition for consistent metadata signatures), except from paper to • E-workflow for internal legal/reg exceptions electronic documents review / approval • Transition from• Strong Scanning / • Moderate transition managing documents Indexing reliance from paper to e-docs to managing data Paragon Solutions, Inc. Proprietary and Confidential - 24 -
  25. 25. Our eTMF ViewRobust eTMF allows organizations to: Reduce Clinical Trial process complexity Improve compliance by adapting or extending processes and systems that ensure inspection readiness Have an authoritative source for trial documentation Increase authorized knowledge sharing Improve accuracy of research results Reduce records storage costs Determine efficient management and migration pathways for TMF records Rely on eTMF as a clinical trial enabler Paragon Solutions, Inc. Proprietary and Confidential - 25 -
  26. 26. Questions and More InformationMichael Agard, Senior Consultant, Paragon Solutionsmagard@consultparagon.comFran Ross, Principal Consultant, Paragon Solutionsfross@consultparagon.comJeff Crawford, Director, Life Sciences, Paragon Solutionsjcrawford@consultparagon.comAndy Lambros, Managing Director, Paragon Solutions, our website at Paragon Solutions, Inc. Proprietary and Confidential - 26 -