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