A primary objective for the outsourcing and procurement divisions of pharmaceutical and biotech companies is to select the best CRO to undertake their project and deliver it to success. A primary objective for the CRO is to deliver the project to success and earn repeat business with the Sponsor. Both parties' core objective is the same: to deliver the study to success. However, for both organizations it is essential that the business objectives are aligned and therefore, when entering into a Sponsor-CRO contractual arrangement, there are various elements of risk to be considered by both parties.
This presentation, the last in a three-part series on best practices for outsourcing, focuses on the components of managing both legal and financial risk through effective contracting.
Check out Part I & Part II of this series:
Part I - Optimizing RFPs: Simple Steps to Better Responses
Part II - How to Select a CRO: Best Practices
This audio conference covers:
- Required legal and financial terms, and why they are necessary
- Payment terms and incentives
- Investigator responsibility
- Timeline management and responsibilities
- Scope creep & change management
About the speaker:
After spending several years working within the pharmaceutical industry, Lynn Polgar has been with Covance for the past five years. She currently manages the US Contract Management group, and took over the position of Associate Director in 2006. In that role, she oversees the group responsible for negotiating and finalizing contracts starting from pre-bid (Confidentiality Agreements) to post-award (LOIs, Clinical Services Agreements and MSAs) through contract maintenance (inclusive of change management). Lynn received her Bachelor of Arts degree in Economics from Moravian College.
Who should attend?
- Outsourcing Representatives
- Contract Managers (Sponsor-CRO contracts)
- Legal Representatives
- Operational Managers
This audio conference is classified as General Interest.