Certara’s PK Submit™ is a plug-in for Phoenix that helps scientists dramatically increase the speed to complete a non-compartmental analysis (NCA) and create validated PK-related CDISC submission datasets. By guiding the user through each step of the NCA, PK Submit makes it easy to focus on delivering valuable scientific conclusions from the study data.
How do you benefit from PK Submit?
- Optimize R&D productivity with a guided, intuitive user interface focused on the key decision points in NCA. Convenient tools enable you to prepare and analyze your data in a fraction of the time.
- Reduce risk of errors using an automated, repeatable process to get consistent results across studies
- Save development time since PK Submit can rapidly create a CDISC compliant, comprehensive regulatory submission package for PK data or for data sharing
Guided, Intuitive User Interface
Complete the full NCA PK analysis and be able to create CDISC compliant output files through one interface – built with PK scientists in mind and eliminating the need to create complex workflows needed to prep data for analysis. PK Submit walks scientists through each step of the process with prompts and tools to guide them through the process.
By choosing PK Submit, you empower your team to streamline the NCA PK analysis workflow efficiently and effortlessly.
Convenient Tools
Discover the power of PK Submit’s comprehensive toolkit, simplifying critical decisions and expediting actions. From data preparation to analysis, our suite covers it all.
Experience streamlined pharmacokinetic analysis with customizable options, unit conversions, and key parameter calculations, all at your fingertips.
Optimize clinical data management with PK Submit’s efficient software capabilities. Elevate your analysis with ease.
Automated, repeatable process
Designed with 30 years of expertise and the guidance of the largest pharmaceutical companies in the world, the PK Submit process has the flexibility to handle all common study designs while providing a repeatable and predictable experience for scientists. Each step of the process is recorded in audit logs to track any changes and exceptions and can be rerun at any time to recalculate the results. To decrease the risk of errors and regulatory audit findings, reports and electronic records are generated from one source.
Comprehensive regulatory submission package
PK Submit was designed to create the entire PK regulatory submission package, including the CDISC domains, validation report, study data reviewers guide, and define file. With its integration into Pinnacle 21, the industry leading CDISC validation and submission readiness software, PK Submit ensures that regulatory submission processes are even more efficient. These files can be exported for collaboration with other parties or to create regulatory data submissions.
PK Submit is ISO 27001 certified by BSI
お客様の貴重な情報資産を保護することが最も重要です。サターラの情報セキュリティ管理システム (ISMS) は ISO 27001 認証を取得しています。当社の認証は、お客様のデータを保護し、機密性、完全性、可用性を確保するという当社のコミットメントを証明するものです。
ISO 27001のもと、堅牢なセキュリティ管理を実施し、厳格なリスク評価を受け、継続的に改善に努めているため、安心してご利用いただけます。
