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Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Case Study Hosted by Certara Synchrogenix: Plain Language Summaries, Patient Engagement, & the EU Clinical Trials Regulation: Meeting the Challenge

Session Chair(s)

Theresa  Shalaby, MSN, RN

Theresa Shalaby, MSN, RN

  • Sr. Regulatory Services Manager
  • Certara Synchrogenix, United States
As the EU clinical trials regulation goes into effect at the end of the year, Sponsors will be faced with the challenge of efficiently and accurately producing large volumes of plain language summaries (PLS). Additionally, an increased demand is expected for patient engagement during PLS authoring. In this session, we will present our solutions to these challenges, which include our Smart Template and our patient engagement tool, Podium. RSVP Required