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EU Commission Releases Draft Annex 11: ...

12/02/2025

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On July 7, 2025, the European Union (EU) Commission and Pharmaceutical Inspection Co-operation Scheme (PIC/S) published an updated draft of Annex 11: Computerised Systems, a supplementary guideline that is part of the Good Manufacturing Practice (GMP). Although it is GMP focused, the guiding principles of the annex can also be applied to other GxP standards.

EU Commission Releases Draft Annex 11: Computerised Systems
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Warning Letter Issued to Investigator of ...

11/18/2025

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In July, 2025, the US Food and Drug Administration (FDA) issued a warning letter to an investigator conducting a clinical trial for pediatric participants. The warning letter was the result of a routine inspection part of the FDA’s Bioresearch Monitoring Program (BIMO) as well as the investigator’s written response to the Form FDA 483.

Warning Letter Issued to Investigator of Pediatric Study
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ISO Release DIS 9001:2026 for Quality ...

11/06/2025

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On August 27, 2025, the International Organization for Standardization (ISO) released a Draft International Standard (DIS) for the ISO 9001:2026 Quality Management Systems (QMS) to ISO member bodies for a twelve-week review and ballot period. The goal of ISO 9001 is to help organizations create and maintain consistency of their products or services and seeks to improve and refine their internal processes and procedures to increase efficiency.

ISO Release DIS 9001:2026 for Quality Management Systems
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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?

FDA Released ICH E6(R2) Guidance!!!

3/6/2018

On February 28, 2018, the FDA released E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry, which can be found here. Other than a few minor clerical differences, the guidance was implemented in entirety from the ICH E6(R2) Addendum, which can be found here. The notice of the draft guidance was published in the Federal Register on September 29, 2015 and was open to comments until November 30, 2015. The final draft was submitted to ICH Assembly and the regulatory agencies endorsed it in November 2016.

Upcoming Webinar on Monitoring Considerations for Clinical Trials Using eConsent – March 8th

2/8/18

Join us Thursday March 8th as Deborah, Elizabeth and SAM discuss the benefits of integrating eConsent into your consenting process as well as the benefits it has on monitoring and data integrity.  Sponsors have the responsibility of ensuring all subjects have been properly consented and which requires onsite visits from the sponsor’s monitor to manage the informed consent process.  These 3 are experts in informed consent and have decades of monitoring experience between them and will speak on the advantages of eConsent from their own personal experiences as well as the challenges they have encountered throughout the years.