What you will learn
Industry best practices for how to:
- Plan, qualify and select a CRO for a clinical study
- Negotiate and align expectations with a CRO
- Better understand the financial and legal complexities of CRO and Site Agreements
- How to perform CRO Oversight
- How to manage a CRO, e.g. how to escalate and resolve issues
- Understand ICH GCP E6 guideline R2 revisions on sponsors, Sites, CROs and Vendors
What your company will get
An employee who feels confident in:
- The outsourcing process including how to select the right CRO for a study
- Aligning expectations and scoping the outsourced activities correctly
- Following up on CRO deliverables, including how to perform high quality Oversight and risk management
- Understanding and using the best negotiation technique as well as the best financial set-up and payment structure
- Resolving issues and conflicts with CROs
- The contents of the legal contract with CRO and Site