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New Final Guidance Q&A on RRAs

07/08/2025

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In June 2025, The US Food and Drug Administration (FDA) released the final guidance titled; “Conducting Remote Regulatory Assessments Questions and Answers” to facilitate understanding about what a remote regulatory assessment (RRA) is expected from establishments when the FDA initiates or requests an RRA.

New Final Guidance Q&A on RRAs
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BIMO Finds Objectionable Conditions During ...

06/23/2025

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On June 5, 2025, the US Food and Drug Administration (FDA) issued a warning letter and FDA Form 483 to an investigator as a result of objectional conditions observed during a Bioresearch Monitoring Program (BIMO) inspection. According to the letter, the investigator did not adhere to the applicable statutory requirements of Title 21 CFR part 312.60 which states: “An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations”.

BIMO Finds Objectionable Conditions During Inspection
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FDA shares FAQs on IRBs

06/17/2025

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In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research.

FDA shares FAQs on IRBs
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Final Guidance Released on IRB Written ...

06/03/2025

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In February 2025, the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP) released the final guidance “Institutional Review Board (IRB) Written Procedures.”

Final Guidance Released on IRB Written Procedures
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Now Available: Clinical Pathways’ Major Changes ...

05/30/2025

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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.

Come Experience the First Ever Metrics Champion Consortium Summit: Nov. 14-15

10/15/18

What: First Ever Metrics Champion Consortium (MCC) Summit

Topic: Clinical Trials Risk and Performance Management Summit. Listen to a panel of subject matter experts present current topics such as metrics, centralized monitoring, critical thinking, and issues and risks management. Our own Sandra “SAM” Sather will present the topics critical thinking and root cause analysis.

When: November 14 and 15, 2018

Where: The Westin Princeton at Forrestal Village; Princeton, NJ map

Book the hotel here

Very Helpful Resource: Good Clinical Practice: A Question & Answer Reference Guide 2018

10/12/2018

Our own Sandra “SAM” Sather is a contributing author for the HIPAA Privacy Rule and FDA Regulated Clinical Trials chapter, which extensively answers questions about protection of privacy during clinical research. The reference guide answers more than 1000 common questions related to US and international Good Clinical Practice (GCP) for clinical trials.