Clinical Trial Services
Clinical Events Committee
The CEC Services group is comprised of experienced nurses and physicians with medical backgrounds specific to your trial, who provide comprehensive medical review and adjudication of clinical endpoints.
Clinical Events Committee (CEC) adjudication is critical to ensuring the generation and recording of quality data in a clinical trial. The CEC provides medical review and adjudication of trial-specific endpoint events.
HCRI offers CEC services in a variety of therapeutic areas and may be contracted as part of a complete trial management package, or as a stand-alone engagement. The uniqueness of HCRI’s formal CEC meeting format allows for vigorous discussion and superior adjudication of endpoint events.
HCRI’s CEC members are Board-certified physicians from the Boston area teaching hospitals who meet on a regular basis to review clinical events and provide adjudications utilizing trial-specific definitions. Each trial is assigned a Clinical Reviewer, either an experienced Registered Nurse or a physician, to assemble the data required for comprehensive analysis and adjudication. In addition to event adjudication, CEC services include:
HCRI offers CEC services in a variety of therapeutic areas and may be contracted as part of a complete trial management package, or as a stand-alone engagement. The uniqueness of HCRI’s formal CEC meeting format allows for vigorous discussion and superior adjudication of endpoint events.
HCRI’s CEC members are Board-certified physicians from the Boston area teaching hospitals who meet on a regular basis to review clinical events and provide adjudications utilizing trial-specific definitions. Each trial is assigned a Clinical Reviewer, either an experienced Registered Nurse or a physician, to assemble the data required for comprehensive analysis and adjudication. In addition to event adjudication, CEC services include:
- Development of the CEC manual of procedures (MOP)
- Participation in the development of case report forms (CRFs)
- Participation in the pre-programming review of edit checks
- Identification of reported and suspected endpoint events
- Preparation of report-quality clinical narrative summaries which may be used as a supplement to regulatory reports and to DSMB or Data Monitoring Committee (DMC) reports.
- Delivery of CEC meeting minutes
