Global Research Services: Integrated instance of Clinical Systems
ChallengeGRS International is a contract research organization headquartered in Rockville, Maryland with offices in Europe and Asia around the world providing services for clinical trials and specializing in cardiac safety. Supporting around twelve clinical trials each year, and operating on three continents, GRS prides itself on using technology effectively. Trying to speed up clinical trial data reconciliation and reduce time to database lock, GRS set out to replace its legacy Safety and medical coding applications with more state of the art applications and to try to integrate these applications with Oracle Clinical, its clinical data management system. In addition to improving data processing capability, Medifacts hoped to improve inter-department communication between its Safety and Clinical Data Management groups. If their systems could work together, it may be able to accelerate timelines on database locks as well as resolve
discrepancies and queries more quickly and effectively.
Solution
To Install Safety and Thesaurus Management systems that work with Oracle Clinical
GRS had worked with BioPharm systems on an Oracle Clinical upgrade and used BioPharm for help desk support. Therefore BioPharm was a natural choice for this new project. After extensive analysis of dominant Clinical Safety and Data Dictionary systems, GRS chose the balance of the Oracle Pharmaceutical Application suite.
GRS and BioPharm chose to create an “integrated instance” in which the Oracle Clinical, Oracle AERS, and Oracle TMS databases reside on the same server. This integration allows AERS and Oracle Clinical to work together to resolve adverse events, and both use the same medical coding dictionaries. Each system can “see” relevant data in the other, thus allowing for cross communication. With a single medical coding system, the Oracle Thesaurus Management System (TMS), dictionaries and coding standards are easy to keep consistent. Though creating this integrated instance carried some technical risks, and had never certified as workable by Oracle Corporation. GRS and BioPharm determined that the functionality gained from such an environment outweighed the potential dangers.
BioPharm Systems executed the full implementation of Oracle AERS and TMS as well as a necessary upgrade to Oracle Clinical. The TMS installation was not so straightforward, as the integrated instance required BioPharm to install TMS twice -- once as a stand-alone and once for AERS – and then consolidate the two. The next step was to bring Oracle Clinical to the highest version. BioPharm then tested and validated these systems to ensure this CRO was ready to run their next clinical trial.
Upon project completion, GRS had quite a learning curve for their Safety department. Nonetheless, the client was very pleased with the results of the implementation. Each department involved is able to drill into the other systems. Sharing and maintaining one common medical dictionary has freed up resources.
Results
A Complete Integrated Environment within the project timeframe
