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Success with Data

entimICE® DARE

entimo Integrated Clinical Environment

entimo's flagship product is a modular enterprise software suite for the clinical development process. It consists of a metadata driven Statistical Computing Environment (SCE) with a tightly integrated Clinical Data Repository (CDR) and a Metadata Repository (MDR). entimICE is unrivaled in the market for out of the box functionality and configurability to adjust to evolving customer demands. It provides superior adaptation capabilities, serving different sizes of communities from small teams to enterprise platforms with thousands of users. It offers flexible interfaces to other systems in the IT landscape while always guaranteeing full regulatory compliance within the system.

Modular enterprise software for clinical development
Highly configurable and scalable platform
Fully compliant with regulatory standards

All-in-one solution

Leverage entimICE DARE for

Enterprise collaboration
  • Single Point of Truth

All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.

  • Access Control

Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported

  • Workflow and Lifecycle Management

Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.

  • Notifications

Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.

  • Enterprise Search

Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.

  • Enterprise Data Access and Exchange

Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.

Regulatory compliance
  • Single Point of Truth

All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.

  • Access Control

Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported

  • Workflow and Lifecycle Management

Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.

  • Notifications

Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.

  • Enterprise Search

Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.

  • Enterprise Data Access and Exchange

Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.

Metadata management
  • Single Point of Truth

All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.

  • Access Control

Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported

  • Workflow and Lifecycle Management

Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.

  • Notifications

Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.

  • Enterprise Search

Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.

  • Enterprise Data Access and Exchange

Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.

Data management
  • Single Point of Truth

All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.

  • Access Control

Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported

  • Workflow and Lifecycle Management

Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.

  • Notifications

Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.

  • Enterprise Search

Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.

  • Enterprise Data Access and Exchange

Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.

Program development
  • Single Point of Truth

All data, programs and artifacts in one place. Secured and controlled. Accessible and traceable. Direct access for primary and secondary use. No uncontrolled copies.

  • Access Control

Flexible role-based permission model, enabling super users to manage permissions for teams without involvement of IT administration. Granular control on any level from global areas down to single objects or even rows and columns in clinical data. Blinding of data is fully supported

  • Workflow and Lifecycle Management

Configurable workflows for all objects over all lifecycle stages including simple review processes, double programming, validation forms, all combined with discussion forums for the users involved.

  • Notifications

Relevant notifications for pending tasks, finished jobs or subscribed system notifications. They can be directly in the system guiding users to the point of action or delivered to your email inbox.

  • Enterprise Search

Granular indexes on all data and metadata in the repository, constantly updated with the most recent changes, allow for powerful searches for information and data throughout the repository. Search definitions and search results are usable individually, can be shared with others, or can be used to trigger automated processes.

  • Enterprise Data Access and Exchange

Direct access to the entimICE Data Repository while respecting entimICE DARE user permissions. Enables programmers to work with their preferred tools, data scientists to search and find data, and everyone to work with clinical data in entimICE using its virtual database driver.

Your benefits

High security of your data and metadata

With entimICE DARE you find all data, metadata and tools in one secure place. Role- and group-based permissions are controlled down to the record level.

Transparency and process compliance

With entimICE DARE, you can be sure to smoothly fulfill regulatory requirements, including FDA 21 CFR Part 11 and ICH GxP. Audit and status reports are just one click away. The solution natively supports the latest clinical standards including all published CDISC standards.

Informed decision making

A comprehensive view of multiple data sources allows crucial go/no decisions to be taken earlier in the R&D process.

High-performing analytical experience

Enterprise Data Access ensures entimICE DARE to be the clinical data hub in your organization, providing clinical data for analysis or processing to any downstream processes or applications.

Reduced administrative effort

Super Users assign access rights and tasks to group members, no need to involve IT or system administrator.

Speed up the development cycle

Spend less time searching for and aggregating data for analysis.

entimICE DARE components

Metadata Repository (MDR)

The entimICE DARE Metadata Repository provides a model-independent standards and metadata repository, handling various types of clinical metadata throughout all stages of the drug development cycle.

Clinical Data Repository (CDR)

The entimICE DARE Clinical Data Repository provides a safe place to store, manage and share clinical data in various formats and from multiple sources. An optional Mapping Generator helps with data transformation.

Statistical Computing Environment (SCE)

The entimICE DARE Statistical Computing Environment is a powerful integrated framework for program development and execution with access to data flows from heterogeneous sources.

Check tools

Integrated checkers ensure early issue detention and comprehensive reports can be used an effective communication tool for analysis and issue resolution.

Submission tools

A dedicated generator guides users to create the define.xml for SDTM and ADaM with just a few mouse clicks.

Implementation

entimICE DARE is installed in the cloud or on premises.

The default configuration can be up and running within a short time at full power. In the course of optional configuration sprints, the system can be fine-tuned to reflect customer specific workflows, hierarchies and SOPs in detail. Additional modules can be licensed on demand and are simple to activate in the configuration.

entimo provides comprehensive support for all project phases including integration of external applications.

DARE add ons

entimICE Indexing Server (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.

  • Fast access to any clinical data or metadata.
  • Unified access to both entimICE data and external repositories/databases
  • Fast access to any Frictionless clinical trial analysis with fewer manual steps.data or metadata.​
  • Easy querying, reducing effort for users.
  • Real-time information delivery for immediate use
  • More efficient overall clinical trial analysis process

entimICE Enterprise Data Access (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.

  • Immediate availability of any data for smooth and efficient analysis of clinical studies.
  • Supports flexible response to unexpected data access requests.
  • Compatible with common analysis tools such as R Studio, Python, and Jupyter.
  • Provides easy, secure, and high-performing access to clinical or related data.
  • Connects seamlessly with common IT tools and data storage technologies.
  • Grants simultaneous access to all data and metadata stored in entimICE.
Interested in learning more? Request the entimICE Add-ons Fact Sheet
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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.

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