This post is sponsored by IMARC Research, Inc.
As a medical device focused CRO, we are often asked the difference between the investigational drug and medical device clinical research process. We view this as a very legitimate question and have actually devoted a whitepaper to explain these differences.
Even though the clinical research pathways for drugs and devices have their differences, there is a common thread that ties the clinical research processes together…patients. Real people exist on the other side of an investigational product and they face real risks when they choose to take part in a clinical research study. Although the investigations of drugs and devices have their variations, by design these distinctions are intended to accomplish the same goal: to safeguard those research participants while bringing safe and effective products to the market as quickly as possible.
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So, while getting to the finish line may look a little different for each pathway, the road requires an ethical commitment combined with the proper controls and an understanding of the differences — in the details — between drugs and devices.
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