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 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 | Mar 30, 2021 | Subscriber Articles
The first thought that typically comes to mind when you hear about an upcoming FDA inspection at your site is the logistics– where to meet, document review, and your facility’s condition. There are however, other factors to keep in mind for both on-site...
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...
