As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

While important, clinical trial protocols merely provide the foundation for success. It is the people who run those protocols, and their use of optimal processes and systems, that determine whether ...

When discussing the future of clinical trials, people often focus on the promise of exciting new technologies, including artificial intelligence (AI) and predictive modeling. However, even the most ...

In the first of a two-parter, lawyers at Santarelli analyse the patentability of therapeutic inventions where publication of clinical trial protocols occurs before the application's filing date The ...

In the second of a two-part article, Gabrielle Faure-André and Stéphanie Garçon at Santarelli unpick EPO, UPC and French case law to assess the importance of clinical development timelines in ...

The answer to this inquiry is “yes” — but maybe “no.” Will confidentiality agreements shield any prior art concerns? Once again, maybe “yes” — but maybe “no.” Indeed, do clinical trials constitute an ...