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Medical Devices

Clementine Global Medical & Operational MD Research team follow three main principles

 

Passionate customer focus Extensive knowledge in multiple therapeutic areas Cross functional teamwork

 

Medical device trials require an added level of specialized service and regulatory knowledge to be executed successfully. Although such clinical trials have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct with critical differences:

  • Class of the device or risk stratification varies the requirement for a clinical trial, to demonstrate effectiveness consistently meets the labelled application.
  • Safety reporting. For devices, manufacturers are required to report all SAEs, even if they are not directly related to the device or the procedure in which the device is used. This requirement applies not just to implantable, but also to in vitro devices and diagnostics which are not used directly by the patient.
  • Clinical trial design and population studied, Medical devices may not be appropriate to insert the device into healthy subjects. Instead, a device trial may be initiated in a small pilot population with the disease or condition under study before moving into the larger pivotal populations.
  • Clinical Trial classification, varies from medicinal products.
    • Exploratory Study at early stages of device development.
    • Pivotal Study to demonstrate the device is safe and effective for a specific use within a defined patient population and it’s used to gain regulatory approval to market the device.
    • Postmarket Study  

Being familiar with the specifications and format of drug and medical device clinical trials is crucial to ensure the trials run as smoothly and efficiently as possible, adding an extra value for successful commercialization.