Investigator Initiated Study (IIS) is not a new concept in the MedTech industry. However, the processes and the compliance framework governing clinical studies have become far more complex due to significant changes.
Although the number of IIS conducted globally is on the rise, manufacturers are facing considerable complexities in increasing their legal, ethical and financial risks. Moreover, the changing nature of clinical trials in the post-pandemic world has added to the complexity and brought new professional challenges.
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