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Data Review Committees in Clinical Trials

Ensuring patient safety through an independent non-biased panel is critical in every clinical program

A Data Review Committee (DRC) is an independent panel of experts who periodically meet during a study to review clinical data. The primary purpose of is to protect the current and future patients in the trial by reviewing safety and exposure data and making unbiased recommendations to the study sponsor based on the results.

A DRC may recommend the study continue with no modification, with modification, or stop all together due to safety concerns. The DRC can also make recommendations based on interim efficacy results - particularly in adaptive design trials - sample size modification or stopping criteria due to efficacy or futility.

Veristat teams develop and organize many types of independent data review committees for clinical trials with various remits. We are experienced in and can help you manage the following types of data, safety and endpoint committees :

Data Monitoring Committee
Data Safety Monitoring Board (DSMB)
Independent Data Monitoring Committee (IDMC)
Safety Review Committee (SRC)
Data Review Committee (DRC)
Clinical Endpoint Committee (CEC) / Clinical Endpoint Adjudication

Veristat has managed over 45 DRCs in the last 5 years across numerous therapeutic indications including Cardiology, Endocrinology, Gastrointestinal Disorders, Genetic Disorders, Infectious Diseases, Neurology, Oncology and Pulmonology.

EBOLA VACCINE

Veristat assembles an ad-hoc data monitoring safety ommittee review of US sites on EBOLA vaccine program to remove clinical hold placed on European sites.

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Identify thought leaders in the relevant indications and medical specialties to sit on independent committee
Draft Data, Safety or Endpoint Committee Charter
Coordinate Data, Safety or Endpoint Committee meetings
Facilitate communication between study sponsor and committee members