Streamlining Drug Development with PK Submit™: Automating CDISC Domain Creation for Regulatory Submissions

In the fast-paced world of drug development, efficiency and accuracy are paramount. With the increasing complexity of regulatory requirements, creating CDISC domains for regulatory submissions can be time-consuming and error-prone. However, Certara PK Submit™ offers a solution to optimize research and development (R&D) productivity, reduce the risk of errors and audits, and facilitate collaboration with Contract Research Organizations (CROs).

Streamlining CDISC Domain Creation: PK Submit™ is a cutting-edge software tool that automates the process of creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions. CDISC is a global standard for organizing and standardizing clinical trial data, ensuring that data can be accurately analyzed and interpreted by regulatory agencies. By automating the creation of CDISC domains, PK Submit™ saves time and reduces the potential for human error, resulting in a more efficient and reliable process.

Flexible Options for NCA Analysis: PK Submit™ is its ability to optimize R&D productivity. The software allows for the automatic creation of a complete electronic regulatory submission-ready package within minutes during the normal process of setting up and executing a non-compartmental analysis (NCA). This streamlined approach significantly accelerates the drug development timeline, allowing companies to bring their products to market faster.

PK Submit™ helps to reduce the risk of errors and audits: Manual data entry and domain creation can introduce human errors, which can have serious consequences for regulatory submissions. PK Submit™ minimizes the potential for errors by automating the process, ensuring that CDISC domains are created accurately and consistently. This reduces the risk of regulatory scrutiny and audits, saving time and resources in the long run.

Seamless Collaboration with CROs: Collaboration with CROs is a critical aspect of many drug development projects. PK Submit™ facilitates this collaboration by allowing for the easy sharing of CDISC domains with CROs, eliminating the need for manual data transfers and reducing the potential for errors. This seamless collaboration streamlines communication, enhances efficiency and ensures that CROs have access to the necessary data for their own workflows, leading to a more integrated and coordinated drug development process.

Compliance with SDTM and SEND Standards : PK Submit™ ensures compliance with industry-standard CDISC models, such as the Study Data Tabulation Model (SDTM) and the Standard for Exchange of Nonclinical Data (SEND). These standards ensure that the data is organized, formatted, and standardized consistently, which is essential for regulatory submissions. By adhering to SDTM and SEND standards, PK Submit™ helps ensure that the submission-ready package complies with regulatory requirements and facilitates a smoother regulatory review process.

Advanced Quality Control Checks: Ensuring data accuracy and quality is paramount in regulatory submissions. PK Submit™ incorporates advanced quality control checks to identify and correct potential errors or inconsistencies in the data. These checks include range checks, data plausibility checks, and consistency checks, among others. By automatically identifying and resolving issues, PK Submit™ helps to reduce the risk of errors in the CDISC domains and enhances the overall quality of the submission-ready package.

PK Submit™ offers a comprehensive and efficient solution for automating CDISC domain creation in the drug development process. With its flexible options for NCA analysis, advanced quality control checks, seamless collaboration with CROs, and compliance with SDTM and SEND standards, PK Submit™ helps to optimize R&D productivity, reduce the risk of errors and audits, and enhance the overall efficiency of the regulatory submission process.

To learn more about PK Submit™ and how it can benefit your drug development projects, contact AK Health at info@akthealth.com.