A Data Monitoring Committee (DMC), also known as an Independent Data Monitoring Committee (IDMC) or Data Safety Monitoring Board (DSMB), is an independent panel of experts who periodically review clinical study data to ensure trial integrity, scientific rigor and patient safety.

Novella offers our customers the necessary expertise for the successful implementation of DMCs. Novella’s Oversight Group Management can manage the process from beginning to end, or work with sponsors on a customized list of services. Our capabilities include:

Member Selection

  • Identify DMC members, with access to a global pool of board certified physicians and key opinion leaders through our Physician Network
  • Manage member contracts and payments
  • Prepare Physician Payment Sunshine Act reports for sponsors

Charter and Process Development

  • Establish a written charter, with well-defined standard operating procedures for committee operations which are in compliance with the FDA Guidance, EMA Guideline and ICH Guideline
  • Collaborate with sponsors to document pre-defined statistical stopping boundaries in the DMC charter. These could be for declaring benefit of a new treatment or appropriate boundaries for harm and futility, as appropriate.
  • Partner with sponsors and the DMC to identify appropriate data required for safety review

Project Execution

  • Coordinate meetings including agendas, logistics, hosting and minutes of appropriate sessions
  • Provide current data reports for periodic safety reviews and interim analyses with expert biostatistician guidance