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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

Supporting Subject Safety and Comprehension with eConsent

11/21/17

The purpose of the Informed Consent Process is to ensure the subject’s understanding of the study prior to enrollment, to protect data integrity and the subject’s safety and rights, and to reduce noncompliance and study drop-outs. Paper consent forms have been used traditionally, but due to more complex clinical trials and longer, more complicated consent forms, they may not be the best option moving forward.

2018 Edition of the International Compilation of Human Research Standards Released

11/16/17

The 2018 edition of the International Compilation of Human Research Standards has been released by the Office for Human Research Protections (OHRP) and can be found here. The Standards compile more than 1,000 laws, regulations, and guidelines from 130 countries, including new countries to the 2018 edition Algeria, Madagascar, Mali, and Saint Lucia. The Standards were created for Sponsors, Investigators, Ethics Committees, and other stakeholders in clinical research, globally. Social-Behavioral research is newly included in the 2018 edition of the Compilation.