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Open-platform environment providing validated integration for multiple programming languages and development tools.
entimICE FastTrack in use

Enabling open source for regulatory activities

FastTrack product logo: A visualization of a fast-tracked clinical submission process showing efficient data flow.
FastTrack product logo: A visualization of a fast-tracked clinical submission process showing efficient data flow.

Your profile

You are working for a biotech or pharma company with an active Phase III clinical trial pipeline, or for a CRO providing biometrics services to sponsors. Your teams are engaged to make use of R in clinical trial reporting activities, in combination with SAS or as a replacement for SAS.

Your challenge

The use of open-source technologies such as R and Python in clinical R&D has been growing steadily for years, with R already successfully used in initial clinical trial submissions to the FDA. However, meeting GxP compliance requirements for these tools is challenging, as neither R nor Python natively provide the necessary controls or documentation to fulfill regulatory standards.

Our solution

entimICE FastTrack delivers a fully validated data science platform with GxP-compliant integrations for SAS, R, and Python, providing a robust foundation for using open-source tools in clinical trial analyses and regulatory submissions.

  • The platform seamlessly integrates with popular open-source IDEs such as RStudio and JupyterHub, as well as commercial solutions such as Posit Workbench.
  • The unified environment of entimICE FastTrack enables customers to manage R package and Python module validation within the same validated setup used for clinical trial programming.
  • With entimICE FastTrack, regulatory compliance is ensured across all programming languages—SAS, R, or Python.
  • This approach makes the creation of deliverables and execution of program runs both simple and compliant.
Take a closer look at the features and performance benefits we’ve developed to bring more speed and precision to every stage of your clinical trial services.

Have a project in mind?

Discover how our solution can streamline your workflows and elevate your results—contact us today to learn how it works for your organization.