Event Adjudication Committees and DSMBs Comprise Seasoned Experts

The value of any clinical research program hinges on the relevance of the research findings and the validity of the data. CRF has a strong reputation in the cardiovascular industry, has privileged access to many well-qualified and leading physicians, and serves as the alliance between sponsors and the committees. At a time when regulatory authorities place greater emphasis on the use of oversight committees, the CRF Clinical Trials Center provides first-rate event adjudication and DSMB services.

Event Adjudication and DSMB

• Our Clinical Event Committees (CEC) systematically identify, adjudicate, and classify clinical endpoint events to ensure they are consistent with prevailing standards; the CRF Clinical Trials Center has CEC experience with more than 350 trials
• Our Data and Safety Monitoring Boards (DSMB) expertly monitor patient safety and treatment efficacy data to provide a risk-benefit profile of the investigative treatment or procedure throughout the life of the trial; the CRF Clinical Trials Center has DSMB experience with more than 100 trials

Member rosters include highly accredited, independent interventional cardiologists, noninterventional cardiologists, cardiothoracic surgeons, neurologists, and other specialists as well as biostatisticians. The CRF Clinical Trials Center Event Adjudication and Reporting Division is led by experts in the field who are committed to ensuring that trial data is consistent, reliable, and of high quality.

Our comprehensive CEC and DSMB services include:

• Identification, recruitment, and contracting with committee members
• Development of committee charter, forms, and case dossiers
• Meeting scheduling, conduct, and reporting
• Entry of adjudication results into CRF or sponsor database
• Independent statistical output for DMC meetings