Our expertise
CERC establishes and coordinates Clinical Event Committees (CEC) and Data Safety Monitoring Boards (DSMB) to ensure independent, expert oversight of clinical trials.
Our mission is to provide scientific and regulatory confidence through transparent processes, rigorous data review, and impartial decision-making.
CERC also manages safety and vigilance activities, including AE/SAE reporting and regulatory compliance (MDR/ FDA/ PMDA/ Country specific), ensuring patient protection and data integrity throughout the study lifecycle.
Who we support
Sponsors and investigators conducting clinical studies requiring independent data and safety oversight.
CERC supports both global multicenter trials and focused cardiovascular studies, adapting committee structure and operations to each project’s needs.
Engagement options
- Full CEC/DSMB coordination: committee setup, meeting logistics, and data management.
- Safety management module: AE/SAE reporting, vigilance, and compliance with MDR and ISO standards.
What we deliver
- CEC and DSMB charter development
- Selection and recruitment of independent experts
- Meeting organization and documentation (virtual or in-person)
- Endpoint adjudication workflow and tracking
- Safety data collection and reporting (AE, SAE, device vigilance)
- Communication with sponsors and regulatory authorities
- Comprehensive safety and adjudication reports for final submission
Our process
- Define: assess study needs and determine committee structure.
- Select: recruit qualified experts and key opinion leaders.
- Set up: establish charters, secure data access, and adjudication rules.
- Operate: manage meetings, data flow, and endpoint adjudication.
- Report: compile results, safety summaries, and recommendations for regulators and sponsors.
Why CERC?
- Extensive experience coordinating independent committees since 2005.
- Strong network of international key opinion leaders in cardiovascular and interventional research.
- CEC technology enabling secure, paperless, and real-time adjudication.
- End-to-end integration with CERC’s Core Lab, Data, and Regulatory teams.
- Recognized reliability by regulatory authorities for trusted, transparent oversight.
Typical deliverables
CEC and DSMB charters, expert roster and CVs, meeting minutes, adjudication logs, safety management plan, AE/SAE listings, and summary safety reports.
Sample outcomes
- Accelerated adjudication timelines through centralized e-CEC workflows.
- Improved regulatory confidence with transparent, high-quality documentation.
Ensure independent and compliant oversight of your clinical studies.
Contact us to learn how CERC’s committees and safety management solutions can support your project.
