Certara®, the global model-informed drug development and decision support leader, today announced the availability of PK Submit™, a technology solution for automating the creation of PK Clinical Data Interchange Standards Consortium (CDISC) domains during Non-Compartmental Analysis (NCA). The US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) both require that CDISC study data standards be applied to preclinical and clinical data submitted electronically as part of a new drug application (NDA).
“As the number of clinical trials being conducted has grown tremendously, it is spurring an equally dramatic increase in the number of new drug and biologics license applications being filed,” said Michael Eckstut, senior vice president and head of Certara’s pharmacometrics software group. “It is now more important than ever that sponsors have access to tools that can automate standardized, manual processes, such as the creation of CDISC files, thus increasing accuracy, improving data organization, and ensuring compliance. Our clients are also finding significant time reductions, thus shortening the time to file regulatory submissions.”
CDISC guidelines apply to all new drug applications (NDAs), investigational new drug applications (INDs), abbreviated new drug applications (ANDAs), and certain biologics license applications. In fact, PK CDISC domains are required when developing the preclinical Standard for Exchange of Nonclinical Data (SEND) and clinical Study Data Tabulation Model (SDTM) datasets needed for a regulatory submission package.
“Customer feedback from our recent Phoenix User Group Meeting further validated the benefits of using our PK Submit tool to make PK workflows more efficient. Customers reported that without PK Submit, it could take anywhere from weeks to months to navigate internal resources to create these domains. As this is one of the final steps in preparing a regulatory package for submission, any delays directly increase time to submission and therefore incur cost,” said Kevin Trimm, head of product management for Certara’s pharmacometrics software portfolio.
PK Submit is integrated with Certara’s Phoenix WinNonlin™ software and supports the automatic generation of a complete electronic PK regulatory submission package, including all necessary CDISC domains, a validation report, study data reviewers guide, and define file during the normal process of setting up and executing an NCA. These documents can all be generated within minutes, from the same source, by a PK scientist who does not need to be a CDISC expert.