Prior to implementing OpenText, the CRO client maintained a custom in-house EDC solution to meet the requirements of its sponsors. Over time, and as new sponsor requirements were added, the implications for compliance, performance, operations, support and maintenance, coupled with a scarcity of resources, made it prohibitive for the CRO to continue with the solution. Some of the key sponsor requirements included:
- Offer EDC data in CDISC LAB data model format
- Support for subsequent sponsor analysis, with data conforming to strict data quality requirements
- Uploading of incremental data feeds in realtime, through services exposed by various sponsor data ingest platforms, without manual intervention
OpenText addressed the inherent complexities of conforming to varying sponsor-specific data and delivery requirements by developing a solution that allows the CRO to hand off its EDC data in native form. The native data is processed and validated between the CRO and OpenText through the implementation of a standard canonical map.
OpenText then takes the validated canonical data and transforms it into sponsor-specific formats. This approach enables reuse of the core data processing logic from one sponsor to another by implementing it on top of the canonical map. Additionally, OpenText™ Lens™ provides the CRO with end-to-end visibility across this data flow so that status and outcome can be verified. OpenText™ Managed Services, which consists of a combination of technology, processes and people, further met the needs of the CRO client by protecting highly skilled resources from the operational aspects of the solution.