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Get Ready for AI Assisted FDA Inspections Part ...

04/30/2026

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In addition to the launch of Elsa, in a press announcement on December 1, 2025, the FDA broadcasted the deployment of Agentic AI capabilities for their employees. Agentic AI is unique from LLM AI due to its capability to plan, reason, and execute multi-step actions in order to achieve a specific goal. This means it can be used to assist with more complex tasks.

Get Ready for AI Assisted FDA Inspections Part 2/3
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Get Ready for AI Assisted FDA Inspections Part ...

04/07/2026

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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.

Get Ready for AI Assisted FDA Inspections Part 1/3
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FDA releases Final Guidance for BIMO Inspection ...

03/23/2026

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On December 19th, 2025, the US Food and Drug Administration released the finalized guidance for industry: Processes and Practices Applicable to Bioresearch Monitoring Inspections. The guidance details the processes and practices of Bioresearch Monitoring Program (BIMO) inspections of FDA-regulated establishments NOT specified in existing FDA guides or manuals.

FDA releases Final Guidance for BIMO Inspection Program Processes and Practices Not Found in Current Industry Guides or Manuals
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FDA Releases Final Guidance on ICH E6(R3)

02/03/2026

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On September 8th, 2025, the US Food and Drug Administration (FDA) released their final guidance for industry on the ICH E6(R3) Good Clinical Practice (GCP). ICH E6(R3) Principles and Annex 1 were finalized on January 6th, 2025, officially taking over the preceding 2016 ICH E6(R2). Annex 2 is expected to be finalized in early 2026.

FDA Releases Final Guidance on ICH E6(R3)
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Finalized Guidance for Industry: Investigator ...

01/08/2026

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On December 15th, 2025, the US Food and Drug Administration (FDA) released the finalized guidance for industry “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices”. Unlike most updates, this finalized guidance is replacing the FDA’s recommendations from two separate final guidance documents: “Safety Reporting Requirements for INDs and BA/BE Studies” from 2012 and “Adverse Event Reporting to IRBs—Improving Human Subject Protection” from 2009, both of which are now withdrawn.

Finalized Guidance for Industry: Investigator Responsibilities for Safety Reporting

eLearning

Bye Bye to Five Whys?!

08/16/2022

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Do you ever wonder why people are not doing what you expect? How do you figure out what went wrong and what constraints are getting in the way of everything working as it should? You may have heard that you need to ask the right question, or even about the Five Whys. But if you have used the Five Whys before, have you noticed that you are not confident in the results?

CRO Oversight Essentials Article Published in Clinical Leader

07/19/2022

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Our article “CRO Oversight Essentials” was recently published in Clinical Leader. Following are some key points.

Oversight does not mean micromanagement. A CRO is contracted for its specific capabilities. It is important to allow the CRO to do whatever it does best and not to overcontrol how they implement.

Trusted Partner Biopharma Institute: Supporting Training for Clinical Trial Management

05/03/2022

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Clinical Pathways has exciting news to share about Biopharma Institute, a trusted partner and reseller for our catalog of eLearning courses. They were featured in Life Sciences Review as a Top 10 Emerging Clinical Trial Management Company of 2022, with an exclusive interview with Sandra “Sam” Sather, VP at Clinical Pathways.