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entimICE® FastTrack

Fast-track your submission. With entimICE® FastTrack.

Clinical data science is a crucial part of the drug development process in pharmaceutical and biotech companies and the key to providing drug and therapeutic innovations that are safer, faster and more cost-effective to the patients.

entimICE FastTrack Statistical Computing Environment significantly increases the efficiency of the clinical data science processes, and supports them to master the constantly growing study pipelines, resource bottlenecks, and ever-increasing regulatory requirements. entimICE FastTrack is ready today for data from decentralized clinical trials and various sources, and it fully supports real-time analysis and the use of AI/ML technologies.

Thus entimICE FastTrack contributes substantially to the goals of biopharmaceutical organizations to provide regulatory reporting outputs faster for major reporting events and as a result accelerate the time to submission.

What people say about entimICE FastTrack


Head of Statistical Programming – Global Pharma

“Our organization is moving from traditional analytical languages to new methods including open-source solutions. Implementing governance for these different processes is a major challenge.”

entimICE FastTrack provides a truly language agnostic Statistical Computing Environment, and ensures regulatory compliance and end-to-end traceability for all commonly used programming languages


Head of Clinical Data Science – Mid-sized Biotech

“We have outsourced most of our statistical programming to services CROs. Importing data deliveries and ensuring quality, timeliness and compliance of various formats in different stages of the drug development process is tedious and time-consuming.”

entimICE FastTrack’s import pipelines can automate detection and import, as well as streamline workflows of data deliveries. From CRF to SDTM or ADaM, any source data format can be handled.


Senior Study Manager – Mid-sized Pharma

“Keeping track of progress or a study is a challenge, as data are processed by different software systems. Integration and communication between these systems and their users often leads to delays.”

entimICE FastTrack offers visual information about study progress, providing a comprehensive overview of submission deliverables. Integration of down- and upstream systems can be achieved using a validated REST API, while integrated collaboration tools facilitate communication among users.


CTO – Biotechnology Start-up

“We are in imminent need of a GxP compliant Clinical Data Repository and SCE supporting Open Source tools. Our organization has limited time and resources for implementation, validation and maintenance of such systems.”

entimICE FastTrack is available as a complete solution, including all levels of support and validation. Customers benefit from decades of experience implementing solutions in the biopharma industry.


Director of Statistical Programming – Global CRO

“Study sponsors require on-time results. With the increasing amount and complexity of clinical data, processing, checking, transforming and delivering them to our clients requires the use of a comprehensive, flexible and validated system.”

entimICE FastTrack saves time and effort by supporting sponsor-specific workflows for the preparation of submission-ready deliverables. Tracking study progress across multiple clinical teams enables CROs to meet sponsor timelines.


Learn more about entimICE FastTrack


Data Science Ecosystem
  • Cloud Technology

    entimICE FastTrack is a cloud-native, next-generation Statistical Computing Environment based on microservices, enabling scalability for business growth.
  • Evolving Business Requirements

    Microservice-based systems are developed quickly and have significantly shorter test and validation cycles.
  • Evolutionary Ecosystem

    Standardized and validated REST APIs allow easy integration of any third-party (open source) tool to entimICE FastTrack.
Statistical Programming
    • Program Development

      entimICE FastTrack is language agnostic and supports the use of any analytical (open source) software such as R Studio, SAS Studio, Tableau or Spotfire.

    • Program Execution

      Programs can be executed automatically or with just one mouse click, with direct access to logs and outputs.

    • Program Traceability

      Program executions generate automatic execution traces, including corresponding inputs and outputs, enabling dependency tracking through visualization and automated re-runs for outdated outputs.

    • Automation Tools 

      The job manager automates repetitive tasks such as complex program sequences. The Open API supports automation beyond system boundaries.
Personalized Computing Environment
    • Flexible Dashboards

      Flexible dashboards guide system users to repository objects, which are relevant for the task at hand.

    • Non-blocking User Interface

      entimICE FastTrack's asynchronous backend and non-blocking web-based user interface mean that users never have to wait for a task to be completed.

    • Customizable User Interface

      User interface elements can be customized to provide optimal support for individual working styles.
    • Choose Your Programming Language

      entimICE FastTrack is language agnostic. SAS and R are tightly integrated, and other languages (e.g., Python) can be used for exploratory analysis.

Universal Data & Information Access
    • Access Any Data Source

      entimICE FastTrack allows FAIR data access from various data sources. Examples include clinical, legacy, biomarker, devices, real-world, and many more sources of information.

    • Access Data in FastTrack

      Open REST APIs enable connectivity with the IT landscape and controlled access to data and metadata in entimICE FastTrack.

    • Information Search

      entimICE FastTrack allows access controlled queries against data, metadata, objects, keywords and text, across large repositories (similar to Google search).
Enterprise Collaboration
    • Study Progress Control 

      Study progress dashboards and reports provide complete status control of all ongoing studies and enable their active management.

    • Workflow & Lifecycle Management

      Preset workflows ensure the process management of all objects over their lifecycle phases, including peer reviews, double programming, and validation forms.
Regulatory Compliance
    • Automatic End-to-End Traceability

      entimICE FastTrack provides automatic and effortless compliance with regulatory requirements and policies, including FDA 21 CFR Part 11, EU Annex 11 and ICH GxP.

    • Regulatory Reporting

      entimICE FastTrack provides a flexible search and reporting engine to easily find relevant information in version control, audit trails, object history, permissions and execution traces.

    • Access Control

      A flexible, role-based permission model enables team leads to manage access control for internal and external users.

    • Electronic Signatures

      Users are asked to provide reliable and reportable electronic signatures for relevant workflow activities.

entimICE FastTrack helps you with

Your benefits from entimICE FastTrack


  • entimICE FastTrack is fully scalable and extendable for business growth, evolving business requirements and changing ecosystem integration needs.

  • entimICE FastTrack can significantly increase programming throughput utilizing integrated automation features and flexible automation options.

  • Set up your own dashboards and work contexts, plus use your preferred tools (SAS, R, or Python) so that entimICE FastTrack looks and feels the way you want it to.

  • entimICE FastTrack provides universal data and information access with entimICE EDA and entimICE Indexing Server

  • Powerful collaborative functionality for increased process control and more efficient teamwork.

  • entimICE FastTrack provides full end-to-end compliance traceability so that the system is audit-proof any time.

  • entimICE FastTrack visualizes the data flow by utilizing version controlled program executions and data dependencies. Study progress dashboards tell the complete story, ensuring timely and effective deliverable management.

entimICE Add-ons

entimICE Enterprise Data Access (EDA)

What is entimICE EDA?

entimICE EDA provides easy, secure and high-performing access to all clinical data and metadata in entimICE, as well as access to external filesystems or databases. Source data are retrieved as virtual tables, which can be joined and combined by a full-featured SQL language. Retrieval of data can be executed by any tool of choice, while individual user access rights are always taken into account.

entimICE EDA Business Value

entimICE EDA enables immediate availability of any data for a smooth and efficient analysis process of clinical studies, even if unexpected data access requests suddenly arise. Any analysis tool, e.g. R Studio, Python or Jupyter, can take advantage of EDA to allow easy, secure and high-performing access to clinical or any other related data. EDA enables connectivity with all common IT tools and data storage technologies, while providing access to any data or metadata in entimICE at the same time.

entimICE Indexing Server (IX)

What is entimICE IX?

entimICE IX is a flexible and powerful search engine for entimICE, providing answers to various queries and questions in real-time. entimICE IX provides access to controlled queries against data, metadata, objects, keywords and text, across large repositories - similar to Google search.

entimICE IX Business Value

entimICE IX queries any clinical data or metadata in a fast and easy way, no matter if the required information is from entimICE, or whether it is information from an external repository or database. entimICE IX provides all required information in real-time for a frictionless and efficient clinical trial analysis process.

Interested in learning more? Request the entimICE Add-ons Fact Sheet

Are you looking for a comprehensive
solution for your RnD process?

If you think entimICE can speed up your clinical development process and want
to find out more about it, our experts will be happy to discuss your project with you.