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Compliance In Focus
Posted by John Lehmann on Tue, May 15, 2012

The Top 5 Complications of FDA Medical Device Trials

Top Five Trial Complications“You do a really good job with complex trials.” 

We're lucky to say that we’ve heard this from several clients over the years. But, while we’re glad for the recognition, it made us ask ourselves a key question. What is it that makes a trial complex?

For pharmaceuticals, trials can be relatively simple. A company makes the drug, the drug is administered to the trial patients and the effects are monitored. There are very few moving parts involved. Medical devices, which can be complex machines in and of themselves, will require training and retraining of all parties that are involved with implementation and monitoring of the device – there are numerous moving parts and numerous opportunities to fall out of FDA compliance.

To help shed some light on common device trial complexities, we’ve written Is Your Trial Complex? The Top 5 Trial Complications. 

We’ve taken a look at the complications that many device makers run into during trials. Here’s the Top 5:

  1. Inexperience with medical device trials
  2. A high number of people/entities involved in the trial
  3. Dual roles acting as both sponsor and clinical investigator
  4. Highly complex devices
  5. Conducting a study outside the U.S.

If any or all of those sound familiar, please read the whitepaper . We’ve addressed these topics and provided some insight into how best to overcome trial complications. We’d also love to hear from you about other complications you’ve seen. Let us know about your unique challenges and we’ll post them here  along with our thoughts on how best to address them.

Topics: FDA, Is Your Trial Complex, Top Five Trial Compliations


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