About us:
The DATA CRU has over 40 full-time staff members including clinical research specialists and coordinators, program managers and coordinators, statisticians, and programmers. The staff are trained in ICH Good Clinical Practice (GCP) and are knowledgeable in FDA regulations for GCP and clinical trials and have 100 years of combined experience in research management. The DATA CRU currently manages dozens of active protocols, ranging from single-site projects to multi-site international longitudinal studies and randomized trials. Our staff are involved in all aspects of study design and protocol implementation. Specifics include case report form creation, electronic data systems development and testing, site training and monitoring, participant engagement and data collection, regulatory documentation and compliance, data and safety monitoring, statistical design and analysis, final reporting, and protocol closeout.
The Research Programming Group (RPG) is a key unit within the DATA CRU. 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 has the ability to create applications on both Linux and Microsoft platforms. Importantly, our web-based electronic data entry and management systems meet CFR 21-11 guidelines.
