Certara, a global technology-enabled drug development and drug safety consultancy, has launched its Preclinical 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 preclinical 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 preclinical 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.
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 analyzed by D360. PCSS also standardizes 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 Jonathan Feldmann, Certara chief technology officer. “Furthermore, by facilitating trend analysis of past studies, PCSS helps improve study design and drug development research.”