Clinical Data and Information Management

Customer: A medical device manufacturer developing products for the clinical oncology market, using proprietary technology for detection of cancer and other human tissue abnormalities

Problem: To design and develop a 21 CFR part 11 compliant database to track patient information and manage the pivotal phase of the clinical trial  

Solution: Tribiosys developed a 21 CFR Part 11 compliant clinical data management system for geographically distributed multi-site pivotal clinical trials. The system was based on Microsoft technologies. Specifically, Tribiosys redesigned and validated the database architecture to comply with 21CFR Part 11 requirements while leveraging existing applications, process flows, and database structures. The design minimized impact to applications relying on existing database structures. The solution included electronic signatures to authenticate electronic records, access management, date & time-stamped audit trails, user identification codes and password administration and record retention. In addition, the system was designed to allow for data transfer between and from independently validated systems from multiple external CROs. The design also allowed for the capability to perform XML-based data interchanges.  

Additional case studies -Clinical Data and Information Management