A partnership success story.debbie elliott
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A partnership success story.debbie elliott

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A presentation by Debbie Elliott of Medpace discussing how to optimize strategic partnerships in clinical research between Pharma and CROs.

A presentation by Debbie Elliott of Medpace discussing how to optimize strategic partnerships in clinical research between Pharma and CROs.

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  • Allows operational staff to focus on their primary responsibilitiesMinimizes miscommunication, delays in decision makingProvides clear and reliable communication to required levels of management- engaging them at times when their level of expertise is most critical.
  • Allows operational staff to focus on their primary responsibilitiesProvides clear and reliable communication to required levels of management- engaging them at times when their level of expertise is most critical.
  • Communicate the sponsor expectations of a quality deliverable and ensure appropriate trial oversight practices aligned with sponsor Quality Systems.Identifies routine points of contact and trigger points to define and ensure oversight of quality
  • Program ManagementResponsible for oversight of project execution and quality across studies within a given compound programOperations CommitteeConsists of director level or above management from each functional area. Oversight of key performance metricsProcess improvementFirst point of escalation for project teams Executive CommitteeExecutive management level (VP, CEO)Development of strategic direction of each organization and how it fits into the relationshipOversight of the Operations CommitteeEscalation point for issues that cannot be resolved by OC
  • Tracks all ongoing projects
  • 1500-3000 sites
  • We had a coordinated training with MP and Sponsor CTMs when we released a new MVRGuidelines provide highlights of collaboration processes that have already been established using CRO SOPsReduced contracting timelines ~50% in some casesReduced DM set up timelines – understanding specs for transfer requirements
  • Company recognition for client – company luncheon – sr management presented importance of partnership and recognition

Transcript

  • 1. FOCUSED. TRUSTED. GLOBAL.EXPERTSA Partnership Success Story Debbie Elliott, PhD Medpace Sr. Director, Clinical Operations
  • 2. FOCUSED. TRUSTED. GLOBAL. What is Partnership? o More than contemporaneous, interdependent work on a common project  A shared goal  An agreement on the methods or standards followed to achieve goals  A plan to measure success and provide corrective actions if deficiencies are identified  A forum to discuss scientific, operational, financial and relationship issues to the benefit of all parties
  • 3. FOCUSED. TRUSTED. GLOBAL. Why Develop a Partnership? o Increase the visibility of the Sponsor and program within the CRO o Streamline communication and escalation pathways o Benefit from senior level medical, scientific and operational oversight
  • 4. FOCUSED. TRUSTED. GLOBAL. Why Develop a Partnership? o Develop mutually agreeable processes and apply lessons learned from previous collaborations o Minimize time and costs associated with CRO identification and outsourcing contracting processes
  • 5. FOCUSED. TRUSTED. GLOBAL. Structuring a Partnership o Quality Agreement  Defines expectations regarding quality deliverables – Staff Qualifications and Training (CRO and Site); SOPs to be followed – Quality Management Plans – Study Plans – Audit Readiness  Trigger points – unanticipated events that may impact the execution of the project – 10% behind in recruitment at given time point – Any discovery that impacts patient safety or integrity of data – For cause audit at clinical site or vendor
  • 6. FOCUSED. TRUSTED. GLOBAL. Structuring a Partnership o Operating Charter  Provides the governance details of the partnership – Partnership principles – Escalation pathway – Objectives of each committee – Key performance indicators and metrics to be measured and evaluated – Meeting frequency, attendees and overall communication within each committee – Meeting documentation and follow-up, includes lessons learned and process improvements
  • 7. FOCUSED. TRUSTED. GLOBAL. Levels of Support o Multi-tiered oversight and management  Program Management Team  Operations Committee  Executive Committee
  • 8. FOCUSED. TRUSTED. GLOBAL. Process/Tools o Routine Meetings o Executive Summaries (biweekly/monthly)  Key milestones/deliverables  Top accomplishments during period  Ranked Risks (typically 5-10) with details of managing the risk  Site trend analysis reporting – Categorical summary of outstanding issues at site – Outstanding issues > 30 days – Categorical summary of protocol violations, safety (adverse withdrawals, notables) – Data quality (entry timelines, query rates)
  • 9. FOCUSED. TRUSTED. GLOBAL. Process/Tools o Financial Reporting  Standardized quarterly reporting  Task based revenue accrual  Pass-through and Escrow incurred vs. budget  Detailed invoicing history  Change in scope listing by project o Finance Subcommittee  Key Finance/Outsourcing/Contracting Staff  Periodic meetings  Expedited resolution of financial and contractual issues
  • 10. FOCUSED. TRUSTED. GLOBAL. Measuring Success o Quality  Process Audits  Regulatory Authority Audits  Protocol Deviations o Clinical Milestones  Actual versus contracted • Final protocol to all sites activated • Final protocol to last patient last visit (LPLV) • LPLV to database lock (DL) • DL to final study report o Contract and Cost Management  Actual versus contracted  Change in scope management
  • 11. FOCUSED. TRUSTED. GLOBAL. Partnership History o Yielding benefits for over 10 years o Encompassing single country and discrete service projects to global programs from IND to NDA o Approximately 80 Cardiovascular, Endocrinology and Oncology trials o 6 NDAs
  • 12. FOCUSED. TRUSTED. GLOBAL. Benefits of Partnering o Share best practices across organizations  Updates to SOPs  Development of a Partner specific Clinical Trial Management Manual to preserve and perpetuate best practices o Add new studies to a previously developed infrastructure  Reduced contracting timelines  Reduced learning curve across functional areas  Improved communication and escalation efficiencies  Realistic expectations of requirement to meet study objectives
  • 13. FOCUSED. TRUSTED. GLOBAL. Benefits of Partnering o Volume discount  Consistent rates o Dedicated Resources  Familiarity and trust built across teams and programs o Leveraging Strengths of each group o Understanding long term/strategic goals of each group  Assists with resource allocation and planning o Commitment to continuous process improvement
  • 14. FOCUSED. TRUSTED. GLOBAL. Conclusion o Developing a partnership requires time, commitment and expertise o The long-term benefits of a partnership exceed the investment needed to create and sustain it o For a white paper written on this subject, go to: o https://www.medpace.com/Offers/5Brilliant/ind ex.html