Watch this webinar for a discussion highlighting a unique and impactful collaboration between TransCelerate’s Clinical Content & Reuse (CC&R) initiative and the Innovative Medicine Institute’s (IMI) EU-PEARL initiative. The session will examine how stakeholders from two industry consortia collaborated and how solutions from each initiative were leveraged to advance the future of master protocol design and platform trial research.
The webinar discusses the EU-PEARL solutions that reflect the harmonized lessons learned from these two initiatives and how this also affected additional inputs to the 2024 TransCelerate Clinical Template Suite (CTS) release. The expert panel shares the critical lessons they learned from these interactions and how they could be applied to future collaboration.
Slides can be viewed here. Watch the webinar here.
Panelists:
- Madhavi Gidh-Jain, Global Head of Medical Writing and Document Management, Sanofi
- Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis
- Peter Mesenbrink, Executive Director Biostatistics, Novartis, EU-PEARL Member
- Cecile Spiertz, Vice President Development Operations, Exscientia, EU-PEARL Member
Ideal Attendees:
- Anyone interested in Clinical Data Interoperability
- Solution Providers that utilize clinical protocol information, such as:
- Study builders and authoring platforms
- Structured content management tools
- Sponsors and CROs involved in processes that consume protocol information, such as:
- Protocol and Development Authoring
- Clinical Trial Digital and Technology Support
- Regulatory Operations, submissions & document management
- Data Manager; Innovation Manager, Infrastructure Manager, Programmers in Clinical Development
- Health Authorities: clinical trial regulators, regulatory submission review (esp. FDA and EMA)
- Solution Providers that utilize clinical protocol information, such as: