Certara, a global technology-enabled drug development and drug safety consultancy, has launched its Pre-clinical Safety Store (PCSS). A companion product to D360 Certara’s integrated solution for the query, analysis and visualization of drug discovery and development data, PCSS enables the capture and validation of file-based pre-clinical study data in a CDISC-SEND architected database, meeting FDA recommendations for standardization of data formats for study data in regulatory submissions.
Pharmaceutical customers who pair PCSS with D360 will be able to access pre-clinical study data from CROs in minutes, in a consistent format, for study monitoring and cross-study analysis. PCSS also offers a terminology mapping tool that provides a consistent view of study data from multiple sources.
Read the full release here.