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Problems Found in Sponsor-Investigator Led Trial

10/30/2025

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On March 25, 2025 the U.S. Food and Drug Administration (FDA) issued a warning letter to the sponsor-investigator of a study due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection. The sponsor-investigator’s written response to the FDA Form 483 were deemed inadequate therefore the FDA issued a warning letter stating that the sponsor-investigator was noncompliant with multiple regulations within 21 CFR part 312.

Problems Found in Sponsor-Investigator Led Trial
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Sponsor BIMO Warning Letter – What is a Drug?

10/08/2025

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On April 30th, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter and Form FDA 483 to the sponsor of a clinical investigation as the result of a Bioresearch Monitoring Program (BIMO) inspection. 40 participants were enrolled in the study and took the investigational product that the sponsor claims was to help individuals with sleeping disorders without submitting an Investigational New Drug (IND) application.

Sponsor BIMO Warning Letter – What is a Drug?
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The EU’s CTR and CTIS is Now in Full Effect

09/22/2025

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On January 31st, 2025, the European Medicines Agency (EMA) reached another major milestone for the implementation of the Clinical Trials Regulation (CTR), the European Union’s (EU) current pharmaceutical legislation. The CTR has updated the many of the CTD policies; promoting communication between trials and regulators, increased transparency between trials and the public, and reducing financial and administrative burdens.   

The EU’s CTR and CTIS is Now in Full Effect
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Did You Catch the Update to the FDA’s IRB BIMO ...

09/09/2025

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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.

Did You Catch the Update to the FDA’s IRB BIMO Manual?
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The Commissioner’s National Priority Voucher ...

08/26/2025

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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.

The Commissioner’s National Priority Voucher Pilot Program

ICH E6(R3) Annex 2 Draft Version is Now Available!

ICH E6(R3) Annex 2 Draft Version is Now Available!

12/23/2024

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On November 6th, 2024, the International Council of Harmonization (ICH) published the draft version of ICH E6(R3) Annex 2, a long awaited update to the good clinical practice (GCP) section of the ICH Harmonized Guidelines.

FDA Releases Final Guidance Q&A on Electronic Systems, Records, and Signatures

FDA Releases Final Guidance Q&A on Electronic Systems, Records, and Signatures

12/19/2024

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In October 2024, The Food and Drug Administration (FDA) released a final guidance: “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”. It is intended for sponsors, principal investigators, institutional review boards (IRB), contracted research organizations (CRO) (all of which are considered regulated entities) and other interested clinical trial stakeholders that use electronic records and systems.

FDA Releases Draft Guidance on Multi-Regional Clinical Development Programs for Oncology Trials

FDA Releases Draft Guidance on Multi-Regional Clinical Development Programs for Oncology Trials

12/04/2024

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In September 2024, the Food and Drug Administration (FDA) released another draft guidance titled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs” for sponsors intending to conduct global clinical development programs (CDP) for new cancer treatments. The guidance provides advice on using evidence obtained from multi-regional clinical trials (MRCT) to support marketing applications.

FDA Publishes Draft Guidance on Integrating RCTs into Routine Health Care

FDA Publishes Draft Guidance on Integrating RCTs into Routine Health Care

11/26/2024

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In September 2024, the US Food and Drug Administration (FDA) published a draft guidance for industry titled: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in association with the FDA’s Real-World Evidence program. This guidance was released the day before their final guidance on Conducting Clinical Trials With Decentralized Elements, both guidance discuss the FDA’s current position on collecting health information from sources outside of the clinical research site in order to improve enrollment and protocol adherence to scheduled visits

FDA Releases Final Guidance on Decentralized Clinical Trials

FDA Releases Final Guidance on Decentralized Clinical Trials

11/18/2024

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On September 18th, 2024, The US Food and Drug Administration (FDA) released a final guidance document titled: “Conducting Clinical Trials with Decentralized Elements” which is intended to inform sponsors, investigators, and other clinical trial stakeholders about the proper implementation of decentralized clinical trials (DCT).