PK Submit™ Effortlessly create submission-ready PK datasets with speed and accuracy

PK Submit automates the generation of CDISC domains and supporting documentation for NCA, streamlining regulatory submissions. Built specifically for PK scientists, this advanced plug-in includes intuitive tools for data mapping, merging, and rule application, as well as the calculation of dose-normalized parameters.

Benefits for PK Scientists

• Simplified NCA PK Analysis: PK Submit streamlines the entire non-compartmental analysis process with a user-friendly, guided interface. This allows scientists to focus on critical decision-making while achieving faster and more efficient results, with customizable options and built-in unit conversions.

• Automated and Consistent Workflows: Automated, repeatable processes minimize the risk of human error and ensure consistent, accurate results across studies. Each step is automatically documented in audit logs, supporting transparency and traceability.

• Submission-Ready Compliance: PK Submit integrates with Pinnacle 21 to generate complete regulatory submission packages, including CDISC-compliant datasets and validation reports—ensuring readiness and alignment with regulatory standards.

Seamless Integration with Your Existing Workflow

PK Submit isn't a standalone solution—it's designed to enhance your existing Phoenix environment. As a native Phoenix plugin, it integrates seamlessly with your current PK/PD modeling workflows, maintaining the familiar interface your team already knows while adding powerful new capabilities.

Comprehensive Ecosystem

PK Submit works even better when combined with Certara's broader ecosystem:

• Phoenix Hosted: Cloud-based access with enhanced compute power

• Certara Integral: Validated data repository for GXP and non-GXP studies

• Phoenix NLME: Advanced population PK/PD modeling capabilities

By automating key processes and providing a guided, user-friendly interface, PK Submit simplifies and accelerates the preparation and analysis of PK datasets. This innovative tool allows scientists to concentrate on uncovering meaningful insights from study data while maintaining full compliance with regulatory requirements.

Transform your drug development journey with solutions that matter. PK Submit™ isn't just software, it's your pathway to more efficient, compliant, and successful pharmacokinetic analysis.

Ready to experience the future of PK analysis? Contact AKTHealth at inof@akthealth.com today to schedule your personalized demo and discover how PK Submit™ can accelerate your path to regulatory success, streamlined processes, reduced errors, and submission-ready PK datasets.