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  • Viraj D replied to the topic CROs in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

    If a CRO is not able to deliver the expected results I am sure there is language within the contract specifying this possible outcome and steps to take to get a proper return on their money and resources. Usually, strong and well supported clinical trials are executed for over 5 years or more. This ensures that the proper data and research is collected as well as evidence that properly claims that the device is not harmful and performs as intended. For some instances, this allows the company to observe possible side effects of the device that may be observed during the trials and correct the issue or label the product with this side effect.