As a clinical trial sponsor, you’re under pressure to be transparent, but how do you ensure your clinical study documents don’t reveal confidential trade secrets when published by regulators?
Starting January 31, when mandatory compliance with EU Clinical Trials Regulation (EU CTR) comes into effect, you’ll need to submit documents for eventual publication much more quickly than you did under EMA Policy 0070 and do under Health Canada PRCI – even if you choose the less-desirable option of deferral.
To help with this, Privacy Analytics offers a complete solution for your clinical document submissions, enabling you to meet your regulatory submission deadlines while protecting patient privacy and identifying and protecting commercially confidential information (CCI).
Join Niamh McGuinness, Senior Advisor, Clinical Trial Transparency and Privacy, to find out how Privacy Analytics can help you:
- Avoid publication deferral
- Identify and protect CCI
- Shorten feedback cycles with regulators
- Build an aligned transparency team