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Patient Registries

The need for Patient Registries

Medical Device Manufacturers supplying “implantable” or “life-sustaining and -supporting” products are required by the FDA (21 CFR Part 821) to track information about the patient and the device to ensure that healthcare professionals and patients can be notified in a timely manner of any risk of harm associated with the device or for product recalls. In addition, many Pharmaceutical companies are using some form of Patient Registries to track efficacy and potential side effect of their drugs.

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Patient Participation

Study Portal is looking for co-design partners who want to enhance Patient participation in a Clinical Trial, like:

  • - use online tools for patient communication during a study
  • - use a Patient forum on study related issues
  • - increase Patient accrual through online information access
  • - reduce Patient dropout through online study feedback