Certara CDISC Technology Solution for the Preparation, Analysis and Submittal of PK Data
Phoenix CDISC Navigator │Phoenix CDISC Workflow Templates │ 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 CDISC Workflow Templates automate the preparation of NCA SDTM clinical and SEND non-clinical data sets into CDISC-ready formats required for FDA electronic submissions. Learn more how these workflow templates can streamline the filing process for your clinical and non-clinical data submissions.
Phoenix CDISC Navigator provides a user-friendly interface that seamlessly imports CDISC data into an analysis-ready format, and then exports CDISC-formatted PK parameters for regulatory submission. It is ideal for scientists who perform non-compartmental PK analysis in Phoenix WinNonlin. Learn more.
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.
|Certara is a CDISC Registered Solutions Provider|