Compliance In Focus

Your trial master file (TMF) tells the story of your entire clinical study, so you want to make sure it’s complete and accurate before the FDA reviews it. 

Hiring a third party to review your trial master file is the best way to ensure you’ve checked all the boxes.

However, the cost of a TMF audit can be significant.

Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important for every trial participant—from the patients to the researchers. Whether the product being investigated is a drug or device, a well-organized, efficient clinical trial can save time and money for each individual and organization involved. Additionally, the faster and more accurately a trial is performed, the faster the new medication or clinical product can be introduced to the market and begins helping the community.

IMARC Research has published a whitepaper outlining the similarities and differences between drug and device clinical trials. Since IMARC focuses primarily in the medical device space, we felt it was important to highlight the differences between the two trials. It has proven to be one of our more popular whitepapers, so we have decided to offer an infographic as a quick reference.