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
