CRO Oversight - Laissez-faire vs. Micromanagement - oder: Wie … · 2020. 6. 4. · CRO Oversight...
Transcript of CRO Oversight - Laissez-faire vs. Micromanagement - oder: Wie … · 2020. 6. 4. · CRO Oversight...
CRO Oversight - Laissez-faire vs. Micromanagement - oder: Wie viel ist zu viel?
Jens Opitz Head Corporate Clinical Operations Merz Pharmaceuticals GmbH
X. Interdisziplinaeres Expertengespraech, PPHplus
Frankfurt, Mai 8th, 2015
The opinions expressed in this presentation are those of the individual presenter and should not be attributed to Merz Pharmaceuticals.
• 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)
Definition of oversight What is (and isn’t) oversight? Blaise Walshe
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
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 sub-
deliverables & processes
• High transfer resources
• Increase resources at CRO
• Less risk of performance
issues
• Less ownership by CRO
• ………….
Marketing authorization
new medical / scientific data
Regulatory requirements
Study conduct most efficient way to control the progress &
deliverables of the project
Goals
Patients’ safety
Or ion
Impact on CRO oversight
Organizational Structure
Corporate Culture
Project Scope
Qualified Staff
Sponsor
• 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
Organizational structure
• 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
Project 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)
Project scope 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
Project scope
• 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
Corporate culture
• Expert knowledge
• Project management skills
• Communication & instruction [delegation] skills
• Controlling & monitoring
• Expectation & relationship management
• Mindset of outsourcing
Qualified staff
• 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)
Conclusion: sponsor organization
• 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)
Conclusion: additional considerations
Thank you very much for your attention !
I very much appreciate your opinion about the right
oversight (management)!
Closure