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 process of setting up and executing a non-compartmental analysis (NCA) and includes all necessary CDISC domains. With PK Submit the need to become an expert in data management and electronic submissions is eliminated.
PK Submit™ is an add-in tool that works with Phoenix WinNonlin®, the gold standard for PK/PD analysis. PK Submit enables PK scientists to solve data management issues faster, in less time with fewer resources, providing significant savings in drug development time.
Ensure Standardization and High Quality of PK Data
- Create a complete electronic PK regulatory submission package
- Automatically generate CDISC domains while executing an NCA with no additional effort
- Easily harmonize, append, and merge data from multiple sources
- Use with all study designs and types
- Remain current with CDISC controlled terminology and implementation guides
- Utilized through an intuitive, simple, single user interface
Benefits of PK Submit
- Optimize R&D productivity
- Reduce risk of errors and audits
- Easily collaborate with CROs
PK Submit was developed by Certara, a CDISC Registered Solutions Provider and experts in PK analysis using Phoenix WinNonlin. Contact us to learn more about how PK Submit can improve your drug development time.
|Certara は CDISC (Clinical Data Interchange Standards Consortium) の登録ソリューションプロバイダーです。|