by Our Team | Jan 2, 2024 | Blog Articles
As we navigate through the new year of 2024, the clinical trial landscape is experiencing transformative changes, particularly in the aspect of inspection-readiness. This abbreviated article provides a focused look into how these changes are influencing trial...
by Our Team | Oct 25, 2023 | Blog Articles, Subscriber Articles
The task of documenting and maintaining records can prove to be a daunting one in the world of clinical research. Effective resource allocation constitutes a delicate equilibrium. Striking the right balance between dedicating resources to training and compliance...
by Our Team | Oct 2, 2023 | Blog Articles, Subscriber Articles
By the 2K Blog /team Q: When is the best time to start preparing for an inspection? After database lock After the inspection announcement After IND/IDE Submission A: If you answered C, you are correct. Inspection Readiness is an ongoing process that...
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 | 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...
