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PK Submit™

Effortlessly create submission-ready PK datasets with speed and accuracy.

Simplify and accelerate the preparation and analysis of pharmacokinetic data

For PK scientists, speed and accuracy are essential at every stage of the drug development lifecycle. Certara PK Submit is a powerful plug-in for Phoenix, designed to streamline non-compartmental analysis (NCA) and generate validated PK-related CDISC submission datasets.

By automating critical steps and offering a guided, intuitive user interface, PK Submit reduces the time and complexity involved in preparing and analyzing PK datasets. This innovative solution enables scientists to focus on extracting valuable insights from study data while ensuring compliance with regulatory standards.

Optimize R&D productivity

Reduce risk of errors

Save development time

Automating NCA analysis and CDISC domain creation for regulatory submissions

PK Submit is a Phoenix plug-in that automates the creation of CDISC domains and supporting documentation for non-compartmental analysis (NCA) in regulatory submissions.

Designed with PK scientists in mind, this innovative plug-in integrates intuitive tools for data preparation, analysis, and reporting. Users can map and merge data, apply complex rules, and generate dose-normalized parameters with ease. By automating the creation of CDISC domains and validation reports, PK Submit ensures regulatory readiness while maintaining flexibility to handle diverse study designs.

Streamlined NCA PK analysis with customizable options and unit conversions

Automated processes reduce the risk of errors and regulatory audit findings

Integration with Pinnacle 21 ensures submission readiness and validation

How PK scientists benefit

Streamlined NCA PK analysis

PK Submit simplifies the entire NCA PK analysis process with a guided interface, enabling scientists to focus on critical decision points and achieve faster results.

Automated, repeatable processes

Reduce the risk of errors with an automated workflow that ensures consistency and accuracy across studies. Each step is recorded in audit logs for traceability.

Comprehensive regulatory submission packages

PK Submit creates submission-ready PK datasets, including CDISC domains and validation reports, ensuring compliance with regulatory requirements.

Related products

Phoenix Hosted delivers faster compute, outsourced validation, and flexibility of access across Mac and PC operating systems.

Included with Phoenix Hosted, Certara’s Integral equips PK scientists with an API-enabled data repository supporting both GXP and non-GxP studies.

A trusted solution for pharmacokinetic, pharmacodynamic, and non-compartmental analysis.

Optimize early-phase trial strategies.

Why Certara

Certara combines cutting-edge technology with decades of expertise to deliver innovative solutions that drive success in drug development.

Certara PK/PD software is widely trusted and utilized by both industry leaders and regulatory authorities.
With over 30 years of innovation in pharmacokinetic (PK) analysis and modeling software, we have established ourselves as pioneers in the field.
Our team brings extensive expertise in preclinical and clinical research, guided by some of the most respected experts in the industry.

"A cloud based solution takes away the need for IT infrastructure around a company. No need for IT support, validation support, computer systems compliance support - a lot of those things are taken over by the company which then can alleviate us to focus more on the science.”

Jocelyn Webb
Charles River Laboratories

Pharmacokinetic and pharmacodynamic data analysis

Certara is proud to offer a golden opportunity for learners and experts in pharmacokinetics & pharmacodynamics! Prof Johan Gabrielsson’s standard book will be available FREE of charge!

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Related resources

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Case Study

Enhancing Pharmacokinetics Workflows at Charles River

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On-Demand Webinar

Requirements for Efficient PK Analysis: Repository to Report

Aggregating your data is the first step in any pharmacometric workflow. For teams conducting thousands of analyses, or building thousands of models, taking that first step quickly and programmatically is...

Watch now

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Blog

Demystifying CDISC, SDTM, and ADaM

Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand how they work and how to use them.

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Fact Sheet

PK Submit™ Overview

Learn how PK Submit accelerates NCA workflows and ensures regulatory compliance.

Your data is safe

Your data is safe with PK Submit. Certara’s information security management systems (ISMS) hold an ISO 27001 certification, ensuring the confidentiality, integrity, and availability of your valuable information assets.

Schedule a demo

Discover how PK Submit can transform your pharmacokinetic analysis workflows. Request a demo today to experience the benefits of streamlined processes, reduced errors, and submission-ready PK datasets.

Accelerate NCA PK analysis with guided workflows

Ensure compliance with automated, repeatable processes

Generate comprehensive regulatory submission packages with ease