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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?

Free Webinar: 3 Major Regulatory Risks You Can Reduce with Electronic Informed Consent

10/7/2016

Date: October 13, 2016

Time: 11:00 am EST | 15:00 GMT

Link: http://tinyurl.com/econsentwebinar

Our own SAM Sather and Mika Lindroos from CRF Health will discuss the important topic of regulatory risks in the informed consent process on this exciting upcoming webinar. As you know, Informed Consent is one of the most cited GCP deficiencies by regulatory authorities and contributes to increases in the risk of delayed approvals, litigation and yes, even trial failure. 

Common Rule Changes and their Effects, as Proposed by the NPRM

8/12/2016

According to the Office for Human Research Protections, the Common Rule, which began circulating in 1991, is undergoing an upgrade of sorts in order to ensure the better protection of human subjects involved in research conducted through clinical trials. The U.S. Department of Health and Human Services has propositioned the revision of the Federal Policy for the Protection of Human Subjects. The goal of the Common Rule’s revision would be to strengthen the overall policy through modernization and an increase and focus on efficiency.

Upcoming Course: Monitoring Electronic Health Records (EHRs): Frequently Asked Questions - Understanding the NEW May 2016 FDA Draft Guidance!

6/14/2016

Date: June 16, 2016

Time: 1:00pm-2:30pm, EDT US

Duration: 90 Minutes - Online

Course Link: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001

UPDATE: This course will include discussion of the NEW FDA Draft Guidance “Use of Electronic Health Record (EHR) data in Clinical Investigations”

Innovations in Electronic Consent: Reducing Regulatory Risk While Improving Participant Comprehension and Retention

6/13/2016

June 14th, 2016, TOMORROW
11:00 am EDT | 16:00 GMT

Key processes within our industry have been in need of substantial change and improvement, one being the informed consent process. 

Informed consent is still one of the most cited regulatory deficiencies, this along with the new technologies available will make electronic consent more and more commonplace. Facing this new reality, we must learn how this impacts each stakeholder.