Vendor-Sponsor Successful Communication. Nathalie Dutil Nov 2012

Transcription

1 Vendor-Sponsor Successful Communication Nathalie Dutil Nov 2012

2 It s all about setting expectations. Lack of communication Miscommunication

3 Presentation overview Strategic Sourcing Oversight Model Trust & Verify Relationship Oversight components Communication Plan Country Management Plan

4 Why outsource?

5 Strategic Sourcing What is Strategic CRO Sourcing Achieve optimized outsourcing operating model while maintaining quality and advantageous economics Objective Build a best-in-class advanced model for outsourcing to drive improved Study delivery Quality Cost efficiency

6 Principles of Strategic CRO Sourcing

7 Features of the CRO Strategic Sourcing Model

8 CRO Strategic Sourcing Key Characteristics Governance Acceptance Criteria and partnership metrics Strategic and Management Operating Committee Transfer of Obligations Functions transferred to CRO Utilize CRO SOPs/systems

9 CRO Strategic Sourcing Key Characteristics Utilization of Sponsor Resources Efficient utilization of sponsor resources Functional plans/service Level Agreements Reduction in Effort and Time No competitive bidding Milestone based contracting Reduce change orders

10 Sponsor Responsibility CRO Responsibility

11 Trust and Verify Relationship Concept used to describe a relationship in which One party to the agreement undertakes various activities designed to achieve a mutually agreed outcome The Other party verifies the activities to confirm that actions required to achieve the outcome were taken and outcome has been achieved

12 SPONSOR CRO: Trust and Verify Relationship The concept serves as the framework within which the partnership processes, tools, templates are designed key performance indicators are defined

13 Embracing Trust Collaboration with the CRO requires that the Sponsor builds trust by partnering effectively For Sponsor, trust is contingent upon: CRO success in meeting timelines Producing quality data Resolving issues through solution focused action plans For CRO, trust depends on: Sponsor engaging in a sincere partnership Sponsor providing critical responses and information to CRO Timely and in a decisive manner Collaboration in sharing best practices in issue resolution

14 Components of Strategic Sourcing Model

15 Items Evaluated During Oversight Supported by: Budget Quality Scope Financials Timelines Deliverables

16 Strategic Sourcing Model: Components Transfer of Obligations & Master Services Agreement CRO applies standardized tools & trackers CRO controls / manages dayto-day activities CRO collates issues with proposed solution strategies CRO uses internal processes & expertise Performance measure

17 Master Services Agreement And Transfer of Obligations (ToO) Enables the Sponsor and CRO teams to initiate a protocol with an understanding of CRO accountability and responsibility for protocol deliverables and in accordance with the scope documents Master Services Agreement & Transfer of Obligations CRO applies standardized tools & trackers CRO controls / manages dayto-day activities CRO collates issues with proposed solution strategies CRO uses internal processes & expertise Performance measure

18 Quality Agreement - MSA Operational Principles Project Management Qualifications of CRO Personnel, Training Expectations Procedural Requirements Monitoring Activities Study Files/Documentation Third Party Vendor Qualifications Process Quality Metrics Audit Process Sponsor/CRO QA Collaboration CRO QA Internal Audit Program Inspection Readiness

19 CRO Responsibilities Apply standardized tools & trackers Master Services Agreement & Transfer of Obligations CRO applies standardized tools & trackers Control/manage dayto-day activities CRO controls / manages day-today activities Collate issues & propose solutions Use internal processes CRO collates issues with proposed solution strategies CRO uses internal processes & expertise Performance measure

20 Ensuring Strong Performance and Continuous Improvement: Tools Trust and verify points Governance structure Portal access to Sponsor Advisory teams to view: - Sponsor selected status reports - key lab and clinical data Dashboard metrics Acceptance criteria Quality agreement Planning and Strategy sessions (between CRO and BMS) Safety Monitoring Plan Database quality audit Medical Management Plan

21 Performance Measures Data quality audits Query rates Number of protocols violations/serious breaches Enrollment rates Low enrolling sites Compliance audit findings Monitoring Visit Frequency Report metrics Master Services Agreement & Transfer of Obligations CRO applies standardized tools & trackers CRO controls / manages dayto-day activities CRO collates issues with proposed solution strategies CRO uses internal processes & expertise Performance measure

22 Communication Plan = Quality Relationship Effective communication through detailed communication plan Building a strong virtual team where everybody is aware/valued Clear process for escalation and resolution of issues

23 Communication Plan Governance Responsibility for Oversight Local Points of Contact Network At Sponsor and CRO Operational Execution Feasibility and Site Selection Study Start-Up Regulatory Operations Project-Specific Information Management Local Medical Oversight Inv. Product and Ancillary Supply Logistics Quality and Training Local Sourcing

24 Country Management

25 Study Start-up Local Sponsor-CRO kick-off meeting Country/site feasibility Site Selection process Site Start-up activities Health Authority submissions

26 Study Start-up: What could go wrong? Site selection by CRO not aligned with sponsor recommendation Number of sites not clearly defined Challenges with site contracts

27 Sponsor Responsibilities Site Selection process Define Protocol deviations Clinical Drug supply packaging, labeling & randomization Health Authority submissions

28 CRO Responsibilities Finalize country/site feasibility Site Start-up activities/contracts with sites Initiate discussions with Sponsor Legal Develop project plan/charter CRO portals and management trackers/tools

29 Patient Enrolment, Treatment, Data Clean-up Country and Site Activation Patient Recruitment Data Collection, review and cleaning Safety monitoring Site monitoring/management

30 Patient enrolment: What could go wrong? Patients difficult to recruit GCP/Quality issues at sites

31 Sponsor Responsibilities Continued operational and data management oversight Monthly review Ad hoc meetings Quality Oversight visits Lessons learned forum/ Regular face-to-face meetings

32 CRO Responsibilities Patient recruitment implementation Data Review Communicate risk/issues

33 Road to Success Local sponsors & local CRO team members must know each other = trust Schedule planning & strategy meetings with crossfunctional stakeholders early Mutual sharing of information / guidance documents (country library, CRO portal) Hold Lessons Learned meetings with local CRO at major study milestones Escalation of risks/issues

34 Thank you!