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Clinical Services

Clinical Plan Development

Methods for collecting clinical data are as varied as the data themselves.  Thoughtful design of a clinical study often means the difference between success and failure, and can make a tremendous difference in the amounts of time and resources spent along the way.  With decades of experience in designing clinical trials for medical devices and cell therapies, MED Institute experts know how to plan efficient data collection processes that also meet applicable requirements and avoid the unseen pitfalls that can stop a trial in its tracks.

Once you know clinical data will be needed, MED can help you tailor a project to the specific data needs by walking you through all of the considerations that need to be accounted for in designing a successful clinical study.  The resulting lean, comprehensive plan can be used to request accurate and detailed proposals.  Considerations to be addressed in Clinical Plan Development at a high level include:

  • IRB strategy (local or centralized)
  • Patient population of interest
  • Most relevant effectiveness and safety endpoints
  • Clinical measures that translate to the required endpoints
  • Statistical hypotheses and sample size based on the appropriate endpoint
  • Schedule of data collection, patient exams, and patient follow-up
  • Data capture system and data management planning
  • Study oversight (e.g., depth and breadth of monitoring)
  • Safety oversight (e.g., use of data monitoring committees or event adjudication committees)

The resulting lean, comprehensive plan can be used to request complete proposals, from MED Institute or other service providers.