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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
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