Open-platform environment providing validated integration for multiple programming languages and development tools.

entimICE FastTrack in use

Enabling open source for regulatory activities

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.

Explore entimICE FastTrack