by Our Team | Sep 27, 2023 | Blog Articles, Subscriber Articles
The Benefits & How to Utilize Them Checklists are invaluable tools in Inspection Readiness programs within regulated industry of pharmaceutical, medical device and biotech companies. They provide a structured approach to ensure that all necessary preparations are...
by Kimberly | Feb 28, 2023 | Subscriber Articles
SOPs are crucial for ensuring compliance and conducting clinical trials. SOPs provide a standardized approach to clinical research processes, which is essential for maintaining consistency and quality across all study sites and participants. The lack of SOPs may...
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 | Mar 23, 2022 | Subscriber Articles
ICH E6 (R3) Guidelines for Good Clinical Practices (GCP) have been a work in progress to put forward changes to the previous R2 version. The overall purpose is to revise principles that account for ethical trial conduct, participant safety, and clinical trial...
by Kimberly | Jan 26, 2022 | Subscriber Articles
I have been asked so many questions about my FDA career and what it was like working with the FDA. I thought it would be best to write about my experience in an interview-based article according to the most frequently asked questions. How were you introduced to the...
