data monitoring committees and
Endpoint Adjudication Committees
Encorium understands process and function as it relates to DMCs and Endpoint Adjudication Committees. Our Medical Monitoring/Safety Surveillance, Biostatistics, Data Management, and Project Management groups have proven expertise in overseeing these committees, as well as managing the timely handling of data to meet critical DMC timelines.
We are experienced in providing data for regularly scheduled DMC meetings, as well as for DMC meetings convened on an ad hoc basis to review data from unanticipated adverse events. Our monitors have extensive experience managing the issues often encountered to ensure that DMC members can efficiently and effectively perform their duties.
Our DMC experience includes Phase I through Phase IIIB trials in multiple therapeutic areas, including cardiovascular, infectious disease, counter-bioterrorism vaccines, neurology, and oncology. |