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Alkermes: Improving TMF Quality and Oversight with Effective Collaboration
Kate Santoro from Alkermes presented on their experience improving TMF quality and oversight through effective collaboration with CROs on their Veeva eTMF system. Key aspects of their process included getting CRO input during system configuration, training CRO and sponsor users together, aligning processes during implementation, and holding periodic check-ins and TMF summits with internal and CRO stakeholders to review metrics and identify areas for improvement. The goal was to drive better sponsor oversight through collaborative working relationships with CROs.
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Alkermes: Improving TMF Quality and Oversight with Effective Collaboration
- 1. Improving TMF Qualityand Oversight with Effective Collaboration Kate Santoro Clinical Trial Manager
- 2. 2019 Veeva R&DSummit 1. About Alkermes 2. System Configuration − Why CRO input is important − Partnering with CROs 3. System (and Process) Implementation 4. Maintenance − New upgrades/enhancements − Periodic check-ins Agenda
- 3. About Alkermes Company: • Mid-sizebiopharmaceutical company • ~2,400 employees globally • 4 locations eTMF History: • Implemented: June 2015 • Two strategic CRO partners • Multiple smaller CRO contributors 2019 Veeva R&D Summit
- 4. A Show ofHands 2019 Veeva R&D Summit
- 5. 2019 Veeva R&DSummit System Configuration and CRO Collaboration CRO Experience Process Sandbox • Electronic system • TMF Reference Model • System understanding • Team training • Both CRO and sponsor • Beneficial workflows
- 6. System Configuration Model 2019Veeva R&D Summit •Workshops •Decisions •CRO feedback •Participation •CRO users (2) •Alkermes •Veeva •System/process Change •Participation CRO Buy-in Build Team MeetingsProcess
- 7. 2019 Veeva R&DSummit System Implementation (Go-Live) Sponsor and CRO Alignment System Training Process
- 8. System Implementation (Go-Live)– Alkermes Experience 2019 Veeva R&D Summit Pilot Study Assess Change (if needed) Process Documents TMF plan Content list Training CRO and Alkermes Onsite session
- 9. 2019 Veeva R&DSummit event 4 Periodic check-ins Metrics System enhancements Notification Options Working teams Stakeholders Measure Share Improve The Maintenance Phase Metrics
- 10. 2019 Veeva R&DSummit The Maintenance Phase – Alkermes’ Experience Internal CombinedStakeholders • Compare • Discuss • Alkermes • CRO 1 and 2 • Working teams • TMF Summit
- 11. 2019 Veeva R&DSummit Goals Alkermes TMF Summit BenefitsEvents Meeting Agenda Attendees
- 12. Driving Sponsor Oversight InterimTMF Reviews Metrics Reviews Lessons Learned 2019 Veeva R&D Summit
- 13. 3 Days in advanceTrends Issues Collaborative working Notice ResolveInform Interim Reviews 30 2019 Veeva R&D Summit
- 14. Reviewing Metrics QC Rejections CycleTimes Submissions 2019 Veeva R&D Summit
- 15. Naming Conventions Flexibility System/Process Changes Communication CRO DifferencesTurnover Lessons Learned Security 2019 Veeva R&D Summit
- 16. 2019 Veeva R&DSummit Veeva Clinical Network Expected Document Lists Future Endeavors
- 17. Alkermes eTMF Timeline June2015 Sep 2019 Jul 2019 May 2016 May 2018 Feb 2019 Oct 2015 Feb 2017 Feb 2018 2019 Veeva R&D Summit
- 18. Questions? For further queries,contact: Kate.Santoro@alkermes.com 2019 Veeva R&D Summit
- 19.