Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
PK Submit™ Creates PK CDISC Domains in Minutes Right From Your NCA Results PK Submit™ automates the time consuming, error-prone and complex task of creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions. It allows PK scientists to automatically create a complete electronic regulatory submission-ready package within minutes during the normal […]
Read MoreCertara 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 […]
Read MoreCDISC SDTM/SEND PK Data Preparation Preparation of clinical (SDTM) and non-clinical (SEND) datasets, while time-consuming and cumbersome, is a critical task required for achieving compliance of electronic 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 […]
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