Compliance In Focus

In the daily chaos of running a medical device trial, it's a struggle to keep from dropping the baton. 

There are patients to enroll, protocols to follow, vendors and large volumes of data to manage. It’s enough to stress out even the most experienced clinical research professionals!

Take a deep breath. Remember all the work you’ve done to plan your trial before it started. Feel confident in your clinical research team, knowing they have been trained to understand and apply all the necessary regulations.

Then, follow these recommendations to keep your medical device trial running smoothly—and stay compliant.

IMARC Research has created a new whitepaper that highlights the Guidance for Ensuring your Clinical Study is Being Designed, Executed, and Monitored in Accordance with the ISO 14155.2011 International Device Standards. The goal of this paper is to introduce some suggestions on how to set up a study for successful compliance with both the FDA regulations and ISO 14155, giving some practical advice on how these additional ISO requirements can be added.

While good organizational skills may present a challenge to many of us, allowing disorder to follow us to work is simply a recipe for disaster. Not only can disorganization create for a hectic day, it can also lead to larger problems with industry compliance standards and FDA approvals. Whether your company is involved in drug trials or device studies, poor organization can leave your site more vulnerable to non-compliance if risk-based monitoring is used. It can also create an unpleasant environment during an FDA audit if there are issues with a Sponsor or site’s compliance with ALCOA (attributable, legible, contemporaneous, original, and accurate) guidelines. (Please refer to our ALCOA infographic for more information.)