Oracle responds to the data-intensive and increasingly networked drug R&D environment in its Health Sciences Clinical Development Center 3.1. The new version begins as an update to the CDC platform developed by trial automation solutions provider Phase Forward, acquired by Oracle last year.
CDC comprises a clinical data repository and a control environment to automate and track the statistical analysis process. In version 3.1, it's integrated with Phase Forward's InForm trial management EDC solution. The InForm piece provides automatic study set-up. But the update takes another step via its integration into the Oracle Health Sciences IT ecosystem, including the Siebel CTMS. Also integrated is Medidata Rave, especially important when CROs are involved.
"Many customers are Rave users," says Martin Young, a VP at Phase Forward prior to the acquisition, via telephone.
Clinical Development Center 3.1 works apart from the Oracle environment, too, and is available as a standalone product. A typical starting point for a standalone purchase, says Young, is a customer who wants a repository downstream from its EDC system to catch the data. Another standalone start point is driven by statistics analysis and reporting, which "was previously uncontrolled," says Young. But with increasing scrutiny from regulators, traceability has become a necessity.
- Automated data load and new execution triggers for data analysis. The system automatically reruns routines against the most recent data and notifies users of data and study changes.
- Enhanced governance capabilities allow users to create validated libraries to drive standardization, control and reuse of data models, macros, and programs across studies.
- Support for Interactive SAS program development.
- Supports multiple languages.