Protocol teams can invest months in expert review and still face costly amendments, frozen enrollment and delayed Phase III ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...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

Generative AI is streamlining the creation of clinical trial protocols, cutting drafting time from weeks to hours while improving accuracy and regulatory alignment. By automating routine sections and ...

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 flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow ...

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 ...

New BPEI preclinical data address treatment protocol, corneal biochemical environment, fungal resistance mechanism, MRSA biofilm inhibition, and ...

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 ...

Giuseppe Aminzade, head of regulatory life sciences in BonelliErede’s Healthcare & Life Sciences Focus Team, reflects on ...

Hermest Hair Transplant Clinic expands its international footprint through clinical innovation, certified training, and ...