Hi Colleague,
While regulatory agencies worldwide clearly recognize the value of eSource data, inspection scrutiny has increased for a variety of reasons. Applying the same paper-driven logic to the digital world, regulators are more focused on data integrity than ever.
This webinar discussion focuses on areas of regulatory concern, the value of upfront collaborations between providers and sponsors to determine important data, along with suggested tools and tactics for sponsors to stay compliant when eCOA data are part of a clinical trial.
Key learnings include:
- Areas of increased regulatory scrutiny
- How to ensure data integrity and inspection readiness
- Other considerations for proactive data review