The Center for Clinical Trials and Data Coordination (CCDC) provides comprehensive clinical trial management support for clinical trials. We have expertise in biostatistics, data management, and study coordination.
The CCDC partners with the Center for Research on Health Care (CRHC) Data Center Biostatistics Core to provide expertise in the development and execution of statistical analysis plans. The Core also includes MS and BS-level statisticians who contribute significantly to developing and conducting analyses as well as interpreting and writing for publications and grant applications. The Core statisticians also have experience implementing data sharing plans with numerous NIH data repositories.
We work with the CRHC Data Center Data Management Core to implement state of the art data management systems that can be accessed from any electronic device. Each data management system is designed to facilitate the workflow of the study. We work with the investigative team to develop the case report form and an integrated tracking system. Our data management systems have the capability to incorporate electronic health record data and are developed using .NET to create the interface and SQL Server for the database.
Our team can create a data management system that is compliant with current data security practices, including FDA's Title 21 CFR Part 11 federal regulations.
The CCDC utilizes clinical research data coordinators who function as conduits between the clinical, data, and statistical teams of each study. They develop, implement, and oversee study-specific procedures for:
- Protocol development & training
- On-site and centralized study monitoring
- Safety reporting
- Regulatory compliance
