CRO/SPONSOR COOPERATION: COLLABORATING FOR A SUCCESSFUL OUTCOME

Transcription

1 CRO/SPONSOR COOPERATION: COLLABORATING FOR A SUCCESSFUL OUTCOME Vibeke Breinholt Director, Clinical Operations, Ferring Pharmaceuticals A/S 18 September 2014

2 Presentation Overview 1. How to choose the optimal CRO? 2. Roadmap of expectations 3. Budget and contract negotiations 4. Successful outcome 5. Common challenges

3 Presentation Overview 1. How to choose the optimal CRO? 2. Roadmap of expectations 3. Budget and contract negotiations 4. Common Successful challenges outcome 5. Successful Common challenges outcome

4 Presentation Overview 1. How to choose the optimal CRO? 2. Roadmap of expectations 3. Budget and contract negotiations Roadmap Succesful outcome of expectations 3. Budget and contract negotiations 5. Common challenges 4. Common challenges 5. Successful outcome

5 How to choose the optimal CRO? RFI RFP Proposal evaluation Bid defense Award Start-up Agreement / Contract Kick-off Meeting Sponsor oversigt Evaluation Defining CRO collaboration: Role and responsibilities (who) Activities and tasks (what) Timelines and milestones (when) Processes and communication (how) Challenges Budget (how much)

6 How to choose the optimal CRO? RFI RFP Proposal evaluation Bid defense Award Start-up Agreement / Contract Kick-off Meeting Sponsor oversigt Evaluation Defining CRO collaboration: Role and responsibilities (who) Activities and tasks (what) Timelines and milestones (when) Processes and communication (how) Challenges Budget (how much)

7 CRO Identification How to choose the optimal CRO? RFI RFP Proposal evaluation Bid defense Award Start-up Agreement / Contract Kick-off Meeting Sponsor oversigt Evaluation Preferred provider? New collaboration? The more details you can provide on: Scope Expectations Estimated timelines Etc. The better information / proposals Combination? you will receive to facilitate evaluation (less individual assumptions and less diversity) Initial selection criteria: General understanding of the project and scope Therapeutic experience Regional coverage Full-service CRO? Team structure Overall project plan

8 The optimal CRO? Young, lean, quality-focused organisation located in Denmark is looking for honest and dedicated partner to provide agreed services.you must be financially stable and must be located in Europe - but have good connections in countries around the globe. We are looking for someone who is flexible to meet our needs and can offer attention to all details of our relationship. Please respond ASAP photo not required! The perfect match is not a CRO that can do the same things that you can do. It is someone that can do what you cannot do yourself the way you would have done it in order to meet the objective of your trial.

9 How to choose the optimal CRO? RFI RFP Proposal evaluation Bid defense Award Start-up Agreement / Contract Kick-off Meeting Sponsor oversigt Evaluation WHO? Which activities do you want to outsource? And why? Which competencies do you have internally? Which competencies are you looking for at the CRO? How can the collaboration with a CRO create value for your project?

10 Roles and responsibilities (who) (1) Evaluation of project specific internal competencies that creates value for your project HIGH - Protocol - Investigators Brochure - Site Selection V A L U E LOW - Translations and local requirements - Monitoring - CRF - Data Management / Statistics - Data Review - CTA (IEC/CA) - Documents and Filing - Investigator Agreements HIGH LOW COMPETENCIES

11 Roles and responsibilities (who) (2) Evaluation of project specific internal competencies that creates value for your project HIGH V A L U E LOW - Protocol - Investigators Brochure - Site Selection - CRF - Data Management / Statistics - Translations and local requirements - Monitoring - Investigator Agreements - Data Review - CTA (IEC/CA) - Documents and Filing HIGH LOW COMPETENCIES

12 How to choose the optimal CRO? RFI RFP Proposal evaluation Bid defense Award Start-up Agreement / Contract Kick-off Meeting Sponsor oversigt Evaluation WHAT? WHEN? HOW? Summarised as the deliverables Roadmap is linked to: - Project Plan - Trial Checklist and SOP list - Risk management plan - Outsourcing specification Applicable for: - Operational team - Clinical team - Outsourced activities

13 Deliverables (what) Focusing on critical aspects to ensure quality while maintaining timelines Stretching / shrinking? Frontloading? Mitigating risks / challenges

14 Deliverables (when) Planning of interfacing activities must be agreed by all relevant team members! Flexibility must be agreed up front!

15 Deliverables (how) change change change Budget Assumptions Expectations Look for synergies! Check the cost drivers! Benchmarking Verify bid according to specs Review again, again and again.

16 Process and Communication (1) Bid Defense Meeting: Emphasize the key critical aspects in the trial and for the project Create a forum for discussion Be honest (but listen) Align initial expectations and assumptions Prepare! Focus on added value Challenges: Limit or omit the sales talk Invite the relevant people (not senior VP but PM!) Include lessons learned, if applicable ( even better if )

17 Process and Communication (2) Don t tell me what you think I want to hear. Have an ambitious but realistic approach Be honest on challenges and risks and provide considerations for mitigation and/or potential solutions Well, tell me anyway what you are going to do if something does not go according to plan

18 Deliverables (how) The Trial Outsourcing Specification should be your Activity Book for CRO (ABC) If assumptions and expectations are clear, everyone will know what to do and when (and how much it will cost) Share with the team Create transparency with those who have to do the actual work Avoid that it is just an appendix to the contract Use it actively during CRA training Trust (but control) Sponsor Oversight Risk Management Plans Process optimisation, if needed Evaluation and lessons learned At the end of the project and as part of the next proposal (incorporate synergies, previous change orders, improvements etc)

19 Budget and contracts Pick two! Quality Scope Quality is embedded in the scope (not extra charge!) Flexibility will impact costs and timelines Transparency Budget variance reports OOS vs Change Orders Justification for changes Milestone payments Time Costs

20 Communication challenges Team Structure: Formal / informal Flexible or bureaucratic? Structure in CRO/Sponsor must be aligned Governance structure Escalation principles/plan Team work: Training! Motivation Work as one team Evaluation and lessons learned Process optimisation

21 Summary Define and agree on expectations early in the process Extent of services (expectations and assumptions) must be transparent to the entire team (ABC) Involve and motivate the team members doing the actual work and let them take responsibility Look for improvements and synergies ( let s be better together ) Acknowledge that changes will impact timelines and costs (and potentially quality) Focus on the added value from the collaboration

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25 QUESTIONS?