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IDMC Services

Independent Data Monitoring Committee

Independent Data Monitoring Committees (IDMCs) have been one of the important components of many clinical trials, especially for large, randomized multisite studies that evaluate treatments intended to prolong life or reduce risk of a major adverse health outcome. US FDA released a guidance in 2019 on IDMC providing recommendations for controlled trials of any size that will compare rates of mortality or major morbidity.

Brightech has provided DMC support services for over 100 trials. This includes preparing tables, figures and listings for open and close meetings, serving as independent statistician as well as serving as project manager for organizing and coordinating DMC meetings.

Services include:

  • Serve as an Independent Statistician or DMC voting member
  • Data monitoring strategy
  • DMC member selection
  • DMC charter writing, interim analysis plan writing
  • DMC executive summary writing
  • DMC management, minutes taking and reporting
  • DMC programming support for open/closed sessions