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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?

Newly Released! Medical Device GCP International Standard ISO 14155:2020

8/04/2020

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The International Organization for Standardization (ISO) is a network of national standard bodies that develop voluntary standards, some which are applicable to clinical research. Some countries or organizations adopt ISO standards as requirements. ISO standards are reviewed every five years, and it takes approximately three years to develop a new standard.

One important standard in global clinical research is ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice. ISO 14155 has been updated to the third edition and released in July 2020.

ACRP Interviewed SAM Sather on Effective Quality Risk Management

7/28/2020

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The Association of Clinical Research Professionals (ACRP) interviewed Sandra “SAM” Sather on “Effective Quality Risk Management as a Mindset” July 8th. An ACRP Fellow, SAM shared her expertise on why the industry frequently misunderstands what is meant by risk-based monitoring (RBM) and quality systems. There is a misconception that clinical trials will either be done with RMB or traditional 100% SDV monitoring, when all trials need to have the approach of being based on risk.

FDA Resumes Domestic Inspections

7/21/2020

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Due to the global pandemic, the Food and Drug Administration (FDA) temporarily stopped onsite inspections in March. In the interim, they have been conducting remote assessments following a risk-based approach. The FDA is planning to resume onsite domestic inspections the week of July 20th. During the reopening, the health and safety of all involved will be a priority, and any regional restrictions will be followed.

Live Webinar Electronic Systems in Clinical Trials July 30th

7/14/2020

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Join Sandra “SAM” Sather as she presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. It includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials.

UPDATE to FDA’s COVID-19 Clinical Trial Guidance on July 2nd

7/09/2020

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With clinical trial sites prolonging restricted access and sponsor or CRO monitors continuing to monitor clinical trials remotely, more clarification of how to proceed in the current environment while maintaining subject safety and data integrity and quality is needed. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on methods of obtaining informed consent from patients in isolation and an additional question and answer.