Ensuring compliance with regulatory agencies’ electronic submission guidelines for preclinical and clinical data is required – for the FDA as well as the PMDA. These guidelines, including the use of CDISC study data standards, apply to any new drug application (NDA), investigational new drug application (IND), abbreviated new drug application (ANDA), and certain biologics license application (BLA) filings.
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 you 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).
Certara is a CDISC Registered Solutions Provider.
Create a complete electronic PK regulatory submission package in minutes, and solve data management issues faster with PK Submit.
- 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
PK Submit™ is an add-in tool that works with Phoenix WinNonlin™, the gold standard for PK/PD analysis. It includes all necessary CDISC domains. With PK Submit, you can:
- Optimize R&D productivity
- Reduce risk of errors and audits
- Easily collaborate with CROs