Clinical trial compliance starts with a strong strategy. IMARC can assist with establishing study protocols, developing a risk-based study plan and training your team to ensure human subject protection and data integrity.
Managing all the moving parts of a medical device trial can be stressful. Our team can lighten your load by assisting with monitoring, data entry, vendor management, safety management and more. (And we’ll make sure the hand-off is seamless.)
You’re so close to the finish line, but you still have a few more hurdles to clear. IMARC can assist with final audits, data lock and analysis and corrective action if your study receives a Form 483 or an FDA warning letter.
To further ensure the safety of medical devices, the FDA is putting a greater emphasis on post-market data collection and surveillance. IMARC can help your team update these processes to comply with the FDA and the new European MDR regulations.
The history of clinical research is both fascinating and troubling. It’s a series of trial and error—followed by regulations that put patient safety ahead of profits. And it’s the reason IMARC Research exists.