by Our Team | Sep 29, 2022 | Blog Articles
As part of a sponsor’s inspection readiness activities, storyboarding is a crucial step that provides a solid framework for addressing challenging or important areas of noncompliance via corrective and preventive actions. With the aid of organizational and risk...
by Kimberly | Apr 28, 2022 | Subscriber Articles
The coordinated and impartial review of all clinical trial-related activities and records is known as quality assurance. In the case of a clinical study, the quality assurance department has a wide range of responsibilities. Quality Assurance (QA) departments...
by Our Team | Jun 22, 2021 | Blog Articles, Subscriber Articles
Having a complete Trial Master File (TMF) is the highest priority for sponsors in terms of providing an accurate picture of the affiliated clinical trial. This article speaks about key aspects and techniques to implement in order to have an inspection-ready TMF. Key...
by Kimberly | May 24, 2021 | Subscriber Articles
The Trial Master File (TMF) stores all essential documents pertaining to the conduct of a clinical trial in compliance with Good Clinical Practice (GCP) guidelines. It is the “backbone” that tells the story of a clinical trial at every phase from start-up to...
by Kimberly | Mar 15, 2021 | Subscriber Articles
What’s wrong with this picture? On a typical workday, you may see nothing wrong with this picture…but place an FDA Investigator or other regulatory Inspector in this room, and you may it see differently. I’ve had the opportunity to work as an FDA...
