About us:
The DATA coordinating and Collaborative Research Unit (DATA CRU) has over 40 full-time staff members, with combined experience in research management totaling over 100 years. Team members include:
- Clinical Research Specialists and Coordinators
- Program Managers and Coordinators
- Statisticians
- Programmers
The DATA CRU has experience in all aspects of study design and protocol implementation for a range of projects, including multi-site longitudinal studies and randomized trials, nationally and internationally. Specific capabilities across the study lifetime include:
- Statistical design and analysis
- Case report form creation
- Electronic data system development and testing
- Site training and monitoring
- Participant engagement
- Data collection
- Regulatory documentation and compliance
- Data and safety monitoring
- Final reporting and dissemination
- Protocol closeout
The DATA CRU is trained in ICH Good Clinical Practice (GCP) and knowledgeable of FDA regulations for GCP. The programming staff have experience in producing stand-alone, client-server, or web-based data management systems, using JAVA, XML, C++, VB, and SQL, and they have the ability to create applications on both Linux and Microsoft platforms. Our web-based electronic data entry and management systems meet CFR 21-11 guidelines.
