Data Monitoring Committee / Clinical Endpoint Committee Services
As a CRO, cardiabase provides support and assists in the selection, management and coordination of Data Safety Monitoring Boards (DSMB), Executive Committees (EC) and Steering Committees (SC), and works on the creation of charters / guidelines to have these committees operational.
cardiabase is aware that a well-informed Data Monitoring Committee does ensure the safety of each study subject.
That relies upon the quality of data to be reviewed, timely communication, and obviously the clinical trial integrity.
We know that Data Monitoring Committee recommendations for study continuation, modification or termination significantly impact the outcome of a new drug in development.
Similarly, a properly run Clinical Endpoint Committee will certainly ensure a standardized, systematic, independent, and unbiased assessment of the clinical trial endpoints.
Data Monitoring Committees (DMCs) are particularly recommended for randomized and/or multi-center studies that evaluate treatments with mortality endpoints aiming to reduce the risk of a major adverse health outcome (link EMEA).
Clinical Endpoint Committees (CECs) are advisable when endpoints or key safety events in a clinical trial include mortality or morbidity. They also can be subjective to reviewer bias and/or cultural differences in multinational trials.
All medical events are assessed and classified by an independent Critical Events Committee that is blinded to study medication allocation
The Steering Committee is responsible for the overall coordination of the medical work of the study. It is made up of representatives with significant reputations in medicine and medical education from around the globe.
The steering committee also takes advice from other experts in specialist areas if necessary
A Safety Committee is a group of workers who function independently of the investigators of a trial, who are charged with ensuring the well-being of the trial's participants, in accordance with Helsinki Declaration principles .
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