October 22, 2024
11 a.m. EST
In the clinical research industry, where patient safety, data integrity, and regulatory compliance are paramount, quality oversight is essential to success. As clinical trial complexity increases, so does the pressure on sponsors and contract research organizations (CROs) to improve efficiency while maintaining quality.
For sponsors, thorough vetting and qualification of a CRO is critical to building quality into clinical trials at the outset. However, CRO selection is just the first of many activities necessary for driving continuous improvement throughout the product development lifecycle. Putting in place robust processes for effective, ongoing CRO oversight enables sponsors to uphold their responsibility for trial conduct and quality and optimizes the likelihood of study success.
In this webinar, we will explore strategies for establishing and maintaining quality oversight over a CRO, from vendor selection to performance measurement.
Topics will include:
- Key components to monitor in CRO and vendor oversight
- Review of ISO and ICH guidelines, including expectations for ICH E6(R3)
- Elements of Quality by Design
- Tips for maximizing audit and inspection readiness
- Nuances of ensuring compliance with global regulations
Speaker:
Theodora (Theo) O’Brien, Vice President, Corporate Quality
Perspectives Blog 