by Kimberly | Nov 29, 2022 | Subscriber Articles
The concept of pharmacovigilance—derived from the Greek and Latin ‘Pharmakon’ (medicinal substance) and Vigilia (to keep watch)—emerged in earnest among physicians and other health experts almost 200 years ago. Initially, the practice amounted primarily to...
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 | 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 | Sep 29, 2021 | Blog Articles, Subscriber Articles
You have just undergone an audit and discovered a gap in your process. What’s the next step? The key to inspection readiness is having an effective CAPA system that not only correct the issues but also prevent them from happening again. Only by identifying the root...
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...
