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overview
Key Learning Outcomes
- Understand the different types of CRO contracting models
- Discover the right tools to evaluate and select CROs
- Identify GCP and budget requirements
- Learn how to prepare an effective Request for Proposal (RFP)
- Measure CRO performance using metrics and KPI’s
- Communication and relationship management for CRO/Sponsor
- Develop a strategic approach in dealing with changes in scope in an on-going project
About the Course
Most pharma, biotech and device companies outsource some or all of their clinical trial programmes to one or more CROs. The differences in operations and project management of a study between in-house and through a CRO are considerable and may cause significant challenges to clinical executives when transitioning to CRO-run project management. In addition, the latest revision to ICH GCP has highlighted the responsibility on the Sponsor to oversee their trials. Agency Inspectors are increasingly focusing on this as an area of weakness in Sponsor companies.
This intensive masterclass aims to provide participants thorough understanding on selection and oversight of CRO. Gain practical solutions on how to better design & implement RFP (request for proposal), bid evaluation, CRO selection and oversee your project to conclusion. Participants will also learn how to deal with on-going changes in the project, CRO/Sponsor partnership optimisation and how to design an effective communication plan. The restrictions caused by Covid-19 as well as implications on CRO oversight & communications will also be discussed throughout the course.
Who Should Attend
- Clinical Outsourcing
- Clinical Operations
- Project Management
- Contract Management
- Clinical Quality Control
- Finance / Purchasing/ Project Controlling
- Medical Affairs
- Procurement / Purchasing
- Strategic Sourcing
- Program/Portfolio Management
- CRO Administration and Management
Live Online Training
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- Learn live online in an interactive environment
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Register today for our Live Online Training courses and fi nd out how they can help you transform the way you work. Contact one of our training consultants on [email protected] to find out more.
Testimonials
“Instructor was candid and gave real world examples, he gave constructive feedback on exercises, group discussions generated a lot of interesting discussion and debate”
Clinical Project Manager, Tessa Therapeutics
“Lot of examples shared by others’ mistakes, different tools/options to consider in project managing & oversight. Trainer offers project management from a different perspective; as well as strategies for measuring, reporting, controlling, resource prediction among other things”
Director – Project Management, Clinipace
Agenda
MODULE 1
SPONSOR PERSPECTIVE OVERVIEW
- Regulatory expectations
- Business expectations
- Project Management of the CRO
OVERVIEW OF WORKING WITH A CRO
- Current CRO business model
- Types of Contracting Models
- Contract versus project management
- Overview of CRO Management Steps
- RFP
- Contract
- Oversight
- Change in Budget and/or Scope
MODULE 2
OVERSIGHT
- Knowing the status and health of your project
- Measurements, KPI’s, reports,
- Documenting CRO tasks and responsibilities
- Vendor oversight plan
SPONSOR/VENDOR COMMUNICATION
- CRO Meetings
- Effective communication plan
- Mode of communication
- Feedback and resolution
CRO QUALIFICATION ANALYSIS
- Criteria during selection phase
- Elements of a contract
- Fees – how to review the budget
- Use of a standardised bid grid
- Services
- Legal
- Evaluation of different selection tools
- Bid defence meeting
- Qualification visit or audit
- Standardised questionnaire
- Negotiating contracts with CROs – key considerations
- Sponsor’s responsibilities
- CRO’s responsibilities
MODULE 3
DEVELOPING REQUEST FOR PROPOSAL (RFP)
- Basic elements
- How your selection criteria, anticipated relationship and oversight affect your RFP
- Use of feasibility studies
ON-GOING CHANGES IN THE PROJECT
- Dealing with changes in scope and/or requests for more resource
- Budget tracking and renegotiation
MODULE 4
TYPES OF SPONSOR CRO RELATIONSHIP
- Preferred provider model
- Single provider model
- Relative size of Sponsor and CRO
BUDGET STRUCTURING, FORECASTING, NEGOTIATION AND COMPLIANCE
- GCP guidelines, regulations, applicable law and best practices
- Structure for CRO-run projects’ budgets
- CRO budget forecasting, negotiation and tracking
- Billing and payment issues with CROs
CASE STUDIES THROUGHOUT
Dedicated Exercises and Case Studies on:
- Setting CRO charge-out rate
- Making CRO reports a tool to help you manage
- Worked example of drafting a vendor oversight plan
- Analysing a CRO budget
- Developing a CRO selection grid and setting objective choice criteria
- Creating an RFP
when & where
24 - 27 May 2022
Live Online Training
27 - 30 Sep 2022
Live Online Training
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.