by Our Team | Oct 13, 2021 | Blog Articles, Subscriber Articles
The national and global regulations for conducting clinical trials involving human participants are known as Good Clinical Practice (ICH-GCP). They include not only quality criteria, but also regulatory guidelines to ensure that all newly created pharmaceuticals and...
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 Our Team | Jun 7, 2021 | Blog Articles, Subscriber Articles
The Trial Master File (TMF) is the backbone of the clinical trial. It consists of essential documents which not only enable the conduct of a clinical trial, but also enable the evaluation of the quality of data produced. One of the questions asked at the beginning of...
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 | May 12, 2021 | Subscriber Articles
Correspondence in the Trial Master File (TMF) is imperative to keep all parties abreast of the details involved. In order to keep all information relevant and the entire TMF streamlined and efficient, it is necessary to decide what is important, applicable, and...
