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.

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.

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.

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.