Guest User
EU Commission Releases Draft Annex 11: ...

12/02/2025

-

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
Guest User
Warning Letter Issued to Investigator of ...

11/18/2025

-

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
Guest User
ISO Release DIS 9001:2026 for Quality ...

11/06/2025

-

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
Guest User
Problems Found in Sponsor-Investigator Led Trial

10/30/2025

-

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
Guest User
Sponsor BIMO Warning Letter – What is a Drug?

10/08/2025

-

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?

New FDA Sponsor-Investigator Warning Letter Sent Due to Insufficient CAPA

3/30/2021

-

What happens when an investigator or a sponsor of a clinical trial does not comply with FDA Code of Federal Regulations? And when they do not comply what needs to be done? Inadequate responses to inspection findings are very negatively impacting. Have you wondered how they are notified they are doing something wrong?

Background

The United States Food and Drug Administration (FDA) requires entities conducting clinical trials to go through steps for approval prior to beginning the trial. They also require adherence to several regulations. When these obligations are not met, it can be detrimental to study subjects, the public, and the integrity and quality of the data. The FDA sends warning letters to clinical research sponsors, investigators and other organizations outlining the errors that were made so they can take appropriate action. (About Warning and Close-Out Letters | FDA)

Visit Clinical Pathways, LLC.com to Hear Our Interview with MCC’s Executive Director Linda Sullivan

3/23/2021

-

Metrics Champion Consortium (MCC) has partnered with Clinical Pathways LLC to expand their eLearning courses on performance management and good clinical practice (GCP). This expansion will add 13 new eLearning courses to their program with more in development.

We sat down with Linda Sullivan, the Executive Director of the WCG - Metrics Champion Consortium (MCC), an industry consortium dedicated to bringing clinical research sponsors, vendors, and investigative sites together to collaboratively develop standardized performance.

Draft GDPR Adequacy Decision for UK

3/02/2021

-

When the Brexit transition period ended at the end of 2020, the United Kingdom (UK) officially left the European Union (EU) single market and customs union. This means that for the purposes of the General Data Protection Regulation (Regulation (EU) 2016/679 or GDPR), the UK is a third country with regards to data transfer. As a third country, personal data transfers require additional safeguards. At the beginning of 2021, the EU-UK Trade and Cooperation Agreement came into effect. A part of this Agreement includes a provision which allows data transfers to continue without additional mechanisms until an adequacy decision is adopted, for a maximum of six months.

Sam Sather a Speaker and Panelist at SCOPE Virtual Summit for Clinical Ops Executives

2/23/2021

-

Topic for Speaking Engagement and Panel Discussion: Central and Remote Monitoring: Leveraging Central and Remote Monitoring in Risk-Based Quality Management

Topic for Panel Discussion: Medical Device Trial Regulations, Quality and Data Management: Navigating a Changing Regulatory Landscape and Accelerating Approvals

Dates: March 2 - 4, 2021

Location: The virtual summit consists of pre-recorded sessions with live panel discussions and live Q&A sessions.

Register: https://register.healthtech.com/reg/scope

Sandra “SAM” Sather is: