“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.