Transparency-by-Design: Build Efficiencies into Your Clinical Document Disclosure Process

8:00 AM or 11:00 AM Eastern Standard Time
Duration: 30 minutes

Since the 2023 relaunch of EMA's Clinical Data Publication Policy (EMA Policy 0070), clinical trial sponsors have seen a marked uptick in regulatory requirements for clinical document publication.

As these documents contain dense personal and commercially confidential information (CCI), protecting this information—through redaction or statistically derived transformation—can pose a significant challenge.

With public document disclosure becoming integral to the clinical trial lifecycle, you can reduce this burden by incorporating best practices in writing transparency-friendly clinical documents.

Join Niamh McGuinness, Associate Director, Safety, Regulatory & Transparency, to find out:

• What makes a clinical document transparency-friendly?
• How do you incorporate best practices into your current initiatives?
• How can our complete solution help you satisfy 3 key requirements - EMA Policy 0070, EU CTR, and Health Canada’s PRCI?

Sign up for either session (or both) to see a short presentation followed by a chance to ask your most pressing questions about EMA Policy 0070 and transparency-friendly clinical documents.