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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?

ICH E6 (R2)

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.

Updated EMA GCP FAQ Guidance: Medical Records Inspection

6/22/2021

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The European Medicines Agency (EMA) Good Clinical Practice Frequently Asked Questions (FAQ) webpage offers guidance on GCP and is updated regularly as additional questions are received. A recently added question with answer regards the inspection of study participants’ medical records by regulatory authorities in the EU.

Question 15: “Do GCP inspectors from regulatory authorities of an EU/EEA Member State have the authority to inspect trial participants’ medical records and other data, even if there is no statement in the ICF establishing that trial participants consent to the review of their medical records and other personal data by EU inspectors?”

New EMA Guidance: Quality Management of Electronic Systems

9/08/2020

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On April 7, 2020, the European Medicines Agency (EMA) released a Notice to sponsors on validation and qualification of computerized systems used in clinical trials. This guidance is applicable for clinical trials conducted in the EU and clarifies that even though a sponsor may delegate all or part of clinical trial activities out to a company, the ultimate responsibility for validation of software tools or electronic systems remains with the sponsor. This guidance also clarifies that most vendors focus on system security of the participant’s personal data, but they lack a focus on how an electronic system used in a clinical trial must comply with Good Clinical Practice (GCP) and the documentation principles of ALCOA+.

Live Webinar Risk Mitigation Changes with ICH E6(R3) and E8(R1) August 25th

8/18/2020

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Change is coming again. Expected updates to ICH GCP E6(R2) and ICH E8 support the agility and adaptability we need to reach the levels of study design, management, and conduct closest to the data and subjects. Taking these theoretical concepts into flexible, reliable, and accountable practices is the next step in more effective trials.

How Can We Work Together to Monitor Quality Source Data Amid COVID-19 Restrictions? Webinar

3/19/2020

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In the rapidly changing environment of COVID-19 restrictions, how can monitors and investigators ensure subjects and their personal health information remain protected and data remains high-quality? The ongoing challenge of site closures, travel restrictions, and social distancing has many unsure of how to proceed.

The Food and Drug Administration (FDA) released a finalized guidance document for conducting clinical trials during the COVID-19 pandemic. It clarifies…