CDISC Technology Solutions

Certara CDISC Technology Solution for the Preparation, Analysis and Submission of PK Data

PK Submit™ │ Phoenix PKAssist™ │ Certara Strategic Consulting

Through our collaborations with regulatory agencies and partnerships with global pharma, CROs and major nonprofit organizations, and as a CDISC Registered Solutions Provider, we continuously strive to provide up-to-date solutions to help streamline the drug development process and compliance requirements for our clients.

The US Food and Drug Administration (FDA) and other regulatory agencies have implemented electronic submission guidelines using standards developed by the Clinical Data Interchange Standards Consortium (CDISC) 1. These standards support the acquisition, exchange, submission, and archive of clinical and non-clinical data sets.

Certara offers a full end-to-end solution of tools and services that streamline routine PK data preparation for CDISC-ready submission, provide NCA-ready analysis of CDISC-formatted data in Phoenix, and eliminate the error-prone and time-consuming task of converting data to a CDISC format manually.

Certara CDISC Technology Solution for PK Data Preparation, Analysis and Submittal

Phoenix PKAssist is a customized reporting solution that includes regulatory compliant data management and CDISC compliant file generation.

PK Submit is an add-in tool that works with Phoenix WinNonlin™and supports the automatic generation of a complete electronic PK regulatory submission package, including all necessary CDISC domains, during the normal process of setting up and executing an NCA.

Certara Strategic Consulting provides a range of pharmacometric services, tailored to the specific needs of each client, ensuring that the modeling & simulation deliverables are embedded in the overall development workflow to optimize the impact of the work. Learn more of the services available to support your strategic drug development decisions and new drug approvals through quantitative analysis and predictive models of diseases, drugs and clinical trials.

1. Providing Regulatory Submissions in Electronic Format – Standardized Study Data, Guidance for the Industry. US Department of Health and Human Services Food and Drug Administration. December 2014.