Certara, the leading global technology-enabled drug development and drug safety consultancy, has launched Pre-clinical Safety Store (PCSS). A companion product to D360, Certara’s integrated solution for the query, analysis and visualisation 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 standardisation 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 contract research organizations (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.
PCSS was developed in collaboration with D360 customers to address specific challenges that they were facing, such as CROs supplying their data in different file forms and using different names for the same test. PCSS uploads study data files into a SEND-based data system so that the information can be readily queried and analysed by D360. PCSS also standardises the naming convention used to match either CDISC-SEND controlled terminology or a customer’s own.
“Capturing study data using PCSS allows real-time study monitoring; it takes just minutes to upload and query the data and eliminates hours of complex file manipulation. That, in turn, permits rapid decision making about ongoing studies,” said Certara chief technology officer Jonathan Feldmann. “Furthermore, by facilitating trend analysis of past studies, PCSS helps improve study design and drug development research.”