Clinical Research

Get Ready for AI Assisted FDA Inspections Part 1/3

Get Ready for AI Assisted FDA Inspections Part 1/3

04/07/2026

-

On June 2, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of their Artificial Intelligence (AI) Tool: Elsa. AI has been seen in many parts of the clinical research ecosystem in recent years such as trial and protocol design, participant recruitment, and safety monitoring, all of which have the potential to enhance trial efficiency and safety.

Did You Catch the Update to the FDA’s IRB BIMO Manual?

Did You Catch the Update to the FDA’s IRB BIMO Manual?

09/09/2025

-

On April 4th, 2025, the U.S. Food and Drug Administration (FDA) updated their Institutional Review Board (IRB) Guidance Manual, part of the Bioresearch Monitoring (BIMO) Compliance Program. Staying up to date with these sorts of regulatory updates will help better prepare for inspections and give IRBs a chance to update any relevant protocols or policies that may not be compliant with these new changes.

The Commissioner’s National Priority Voucher Pilot Program

The Commissioner’s National Priority Voucher Pilot Program

08/26/2025

-

On June 17th, 2025, the U.S. Food and Drug Administration (FDA) introduced its Commissioner’s National Priority Voucher (CNVP) pilot program to accelerate development of select drugs or biologics from companies that are supporting U.S. national interests and are aligned with U.S. national health priorities.

EMA Releases Guidelines on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

EMA Releases Guidelines on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

08/11/2025

-

On June 4, 2025 the European Medicines Agency (EMA) posted a guideline titled: ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials. Individuals who are pregnant or breastfeeding make up a significant portion of the world’s population, however, the European Union (EU) reports that less than 0.4% of clinical trials currently submitted to the EU include pregnant people and only 0.1% include lactating individuals. This guideline highlights the importance of including these individuals as well as the steps that should be taken in order to ensure their safety during a trial.  

Inadequate Source Documentation Results in FDA Warning Letter

Inadequate Source Documentation Results in FDA Warning Letter

07/29/2025

-

On May 29th, 2024, the US Food and Drug Administration (FDA) issued a Form FDA 483 and subsequent warning letter to a Principal Investigator (PI) as the result of objectionable conditions found during an inspection under the Bioresearch Monitoring Program (BIMO).