Center for Professional Innovation & Education, Inc., Malvern, PA
Feb. 20 & 21, 2014
This course will provide the attendees with the specific methodology and management techniques to successfully outsource pharmaceutical programs that should then be more likely to be completed on time, within budget, and most importantly, with a high level of quality and performance. Participants will learn how the current external and internal forces are shaping the way projects will need to be delivered to be competitive and cost efficient given the state of the industry.
The following topics will be discussed:
- Types of CROs
- All or none - What should you outsource?
- How the FDA views CROs
- Sponsor responsibilities
- Writing the RFP
- Evaluating responses to the RFP
- Pre-Qualification of vendors and vendor audits
- Contract negotiations and partnering with CROs
- Managing the CRO
The processes in managing CROs, including study plans, in-field site visits, preparation for inspections, and monitoring evaluation programs will be discussed. Progress and conditions for terminating the services of a CRO will be analyzed along with the overall requirements of data quality assurance. Solutions to problem assessment and correction involving all outsourcing projects along with the legal requirements of sponsors and CROs are included in the presentations.