Vendors provide services that are critical to the successful outcome of a clinical study, yet sponsors retain the ultimate responsibility for activities that are outsourced. If a sponsor gives control of some study activities to a vendor, the sponsor should take measures to ensure the vendor is delivering products or services of acceptable and repeatable quality. This chapter provides recommendations for evaluating, selecting, and providing oversight of vendors to determine whether their services adequately meet quality expectations and regulatory standards.
After attending this webinar, the participants should understand:
- The purpose of, and regulatory basis for Vendor Selection and Management;
- Differences in outsourcing and contracting models
- How to apply a risk-based approach to different outsourcing models
- Process for vendor selection
- Contents and organization of a vendor scope of work (SOW)
- Processes for vendor oversight
- Governance models for strategic partnerships
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
Individual registration: $50 member / $100 non-member
Group registration (max. 10 people per group): $150 member / $300 non-member
Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.