By fine-tuning domain-specific models with real clinical operations data — such as historical performance, feasibility ...

AI in clinical trials holds great promise for the entire drug development lifecycle. However, any new technology should ...

Yseop uses a natural language processing system to speed up its clinical study submission processes by analyzing data and automating the production of key documentation. (iStock / Getty Images Plus) ...

Despite being a cornerstone of cancer treatment advancement, clinical trials remain inaccessible for many patients because of structural, socioeconomic, and systemic barriers. In this ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according to a recent paper ...

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 ...

When you say sponsors should think of their clinical protocols as “data”, what do you mean? For a lot of non-data-scientists, the word “data” typically conjures up images of numbers and spreadsheets.

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

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 ...