Data Standards and Integration

PRA's Global Data Management team provides clients with robust data integration solutions that adhere to both industry and client data standards.

Data Integration

PRA typically collects clinical trial data across many systems. Although we must integrate the data at the point of analysis, there are stages during the study lifecycle where real-time integration provides great benefit to project delivery. By using data reporting tools like JReview^®, we can avoid complex data integration but still reap its benefits through virtual integration for reporting purposes. Actual real-time integration shows great benefit for study sites, however, when employed between the clinical database and the IVR/IWR randomization and trial-supply data. The DataLabs^® EDC system has developed a cutting-edge partnership with ClinPhone IVR/IWR to provide a full and seamless integration between these two industry-leading applications. This integrated solution provides the following capabilities within a single technology:

• EDC
• CDMS
• Randomization
• Trial supply management
• Electronic Patient Reported Outcomes (ePRO)

This integration provides:

• The ability to enroll and manage study supplies in a single system, either through the EDC interface or through the more traditional telephone interface
• Automated real-time data exchange between EDC and IVR
• A full audit trail for all integration transactions
• Assurance of the quality and reliability of the clinical data
• The ability to share critical screening, withdrawal and randomization/stratification data between the applications
• The elimination of re-keying of data and of reconciliation activities between databases

Integration options around other data sources and in other EDC platforms exist as well. PRA integration experts are available to guide the best structure and integration plan for a successful trial.

Data Standards

PRA has been an active member of the CDISC (Clinical Data Interchange Standards Consortium) Industry Advisory Board since 2004. We also have been an active member of the CDASH (Clinical Data Acquisition Standards Harmonization) initiative to build consensus on consistent CRF content standards since 2006. PRA has expertise in the mapping and converting databases to industry standards like SDTM (Study Data Tabulation Model) and to clients' internal data standards. Automated creation of converted and analysis datasets is also a cutting edge technology employed at PRA to reduce the amount of error in dataset creation as well as reduce the effort to create the final product of analyzable clinical data. PRA's Data Management teams of programmers are available to offer advice and support on the use of the industry data standards.