Certara 的 PK Submit™ 是 Phoenix 的一个插件，可帮助科学家大幅提高完成非房室分析 (NCA) 的速度，并创建经过验证的 PK 相关 CDISC 提交数据集。通过指导用户完成 NCA 的每个步骤，PK Submit 可以让用户轻松专注于从研究数据中得出有价值的科学结论。
您如何从 PK Submit 中获益？
- 在执行 NCA 时自动生成 CDISC 域
- 采用引导式直观用户界面，重点关注 NCA 的关键决策点，优化研发效率。便捷的工具可让您在极短的时间内准备和分析数据。
- 在执行 NCA 时自动生成 CDISC 域
- 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
Protecting your valuable information assets is paramount. That’s why we are proud that Certara’s information security management systems (ISMS) holds an ISO 27001 certification. Our certification proves our commitment to safeguarding your data, ensuring its confidentiality, integrity, and availability.
With ISO 27001, you can have peace of mind knowing that we have implemented robust security controls, undergone rigorous risk assessments, and continuously strive for improvement.
