CRO Oversight - Laissez-faire vs. Micromanagement - oder: Wie viel ist zu viel?

Transcription

1 CRO Oversight - Laissez-faire vs. Micromanagement - oder: Wie viel ist zu viel? X. Interdisziplinaeres Expertengespraech, PPH plus Frankfurt, Mai 8 th, 2015 Jens Opitz Head Corporate Clinical Operations Merz Pharmaceuticals GmbH The opinions expressed in this presentation are those of the individual presenter and should not be attributed to Merz Pharmaceuticals.

2 Definition of oversight What is (and isn t) oversight? Blaise Walshe Oversight magic SOP and/or contract oversight Micromanagement oversight Regulatory authorities have not defined oversight Oversight = management by overseeing the performance or operation of a person or group Oversight is a documented output from a mix of process, people, tools and philosophy working to realize the value of partnership *Source: Statement of Blaise Walshe, Director Jefero Consultant LT (Meeting London March 2015)

3 Definition of oversight What is (and isn t) oversight? In this presentation Ensure transparent transfer of duties to a CRO = contract and SOPs Implement adequate management processes to ensure patients safety and regulatory requirement of outsourced clinical study (program) = Oversight Requested by authorities, but not defined in detail Management of CRO micromanagement Extent of oversight has to be decided by the sponsor

4 Comparison Laissez-faire Focused on main deliverables Low transfer resources Less sponsor intervention Higher risk of performance issues More ownership by CRO. Micromanagement Focused on many subdeliverables & processes High transfer resources Increase resources at CRO Less risk of performance issues Less ownership by CRO.

5 Goals Marketing authorization new medical / scientific data Patients safety Regulatory requirements Study conduct most efficient way to control the progress & deliverables of the project

6 Impact on CRO oversight Organizational Structure Corporate Or Culture ion Project Scope Qualified Staff Sponsor

7 Organizational structure Key competencies What should be done in-house Outsourcing model Processes, roles & responsibilities (internal policies & SOPs) e.g., Project/line organization (tools: e.g., budget/risk management) CRO management (including selection process, outsourcing principles: e.g., trust, transparency. ) Purchasing & contracting policy Quality control/deliverable plan (e.g., release of documents) Staff qualification

8 Project scope Contract Scope of services (of work) Responsibilities (Sponsor / CRO) Timelines, milestones & budget Specifications/deliverables (product definition, performance details, acceptance criteria, sponsor SOPs and templates) Legal and financial terms and conditions Regulatory requirements Key team members of CRO functions (Sponsor) Relevant SOPs (Sponsor) Countries, number of sites

9 Project scope scope Project plan Goals & scope (time, resources, quality, deliverables) Roles & responsibilities of team members (team structure) Communication, escalation process between Sponsor & CRO Risk and mitigation plan Reporting process to sponsor (frequency, reporting template, meetings, meeting minutes including decision log) SOPs, templates & other manuals References to other key documents (e.g. safety plan, regulatory plan)

10 Project scope Project governance Support the joint goal and ensure successful collaboration Review of high level progress (milestones & quality, metrics & KPIs = performance) Support process improvements Review and ratification of proposed solutions of high level issues escalated from the project team Implementation of lessons learnt Members are the senior management of Sponsor & CRO

11 Corporate culture Reason & intention of outsourcing Value of outsourcing Common understanding of the management of CROs by the functional groups Transfer resources for management of CROs are transparent Mindset of outsourcing

12 Qualified staff Expert knowledge Project management skills Communication & instruction [delegation] skills Controlling & monitoring Expectation & relationship management Mindset of outsourcing

13 Conclusion: sponsor organization Organization defines the framework of outsourcing and management of external provider Contract and project plan outline the details, the scope of work and CRO oversight (collaboration between Sponsor & CRO) Corporate mindset and individual qualification of staff influence significantly the resources needed to manage a CRO Continued improvement by lesson learnt (reduces risks of failure & transfer resources)

14 Conclusion: additional considerations Organization and structure of CRO Team structure and qualification of assigned CRO staff Complexity & benefit/risks of a study Common understanding of the project scope and deliverables of Sponsor & CRO Project management skills (e.g., reporting, risk & budget management) Implementation governance or oversight models (structure)

15 Closure Thank you very much for your attention! I very much appreciate your opinion about the right oversight (management)!