Clinical Advisory Boards are established by Medical Device sponsors to seek opinions from clinical subject matter experts who play a key role in advising the company’s clinical programs and overseeing the clinical development process.
A sponsor may choose to appoint an Executive Committee or Steering Committee to provide oversight for the overall direction and strategy for a clinical trial. This committee may include investigators, other experts not otherwise involved in the trial, and usually representatives of the sponsor. The Executive or Steering Committee may contribute to the design of the study, increase information exchange at an early stage of trial development, increase the efficiency of clinical trial collaboration and, in many cases, contribute to the publication of the study data. These individuals may also participate in open sessions of Data Monitoring Committee (DMC) meetings and communication of DMC recommendations following each DMC review of the trial data.
Novella offers our Medical Device customers the necessary expertise for the successful implementation of Clinical Advisory Boards, Executive Committees and Steering Committees. 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 Clinical Advisory Board, Executive and/or Steering Committee 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
- Establishing a written charter, with well-defined standard operating procedures for committee operations
- Board and Committee meeting coordination, including agendas, logistics, hosting, facilitation, and minutes of appropriate sessions