IT Services include design, development and support for solutions built on two of the industry’s most trusted commercial platforms: Oracle AERS and Empirica Trace. Our primary safety system, TRACE, is built on the Empirica Trace platform and provides exceptional security and flexibility “out of the box”, including TRACE tools only available at TRI to accelerate data entry and eliminate the need for reconciliation for clients with clinical trial data in our triDMS™ or other E2B-enabled CDMS.

Unlike software publishers, TRI delivers a holistic, comprehensive solution by coupling the system with the in-house expertise provided by TRI’s doctors, nurses, certified safety specialists and QA staff. Clients securing a TRI implementation of TRACE or AERS benefit from immediate and continuous engagement with medical experts.

TRACE is fully validated and compliant with 21 CFR Part 11 as well as E2B requirements. All of our Safety systems include:

• 24/7 system availability for the intake of adverse events answered by RN and Pharmacists
• Complete and accurate documentation of case data, including checks for duplicate cases
• Timely completion of CIOMS, MedWatch 3500A and other reports
• Preparation of periodic reports
• Updates to common dictionaries (MedDRA, WHO) to keep coding current and correct
• Medical literature searches to identify and process reportable cases
• Signal Detection
• A TRI exclusive, automate reconciliation and reporting of Safety and Clinical Trial Data through custom batch processing of data in a TRI reconciliation database
• Monitoring of safety issues and incidents over time using audit trail