entimICE® DARE

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.

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.

    • Version Control

      All objects of any type under version control. Automatic creation of new versions for each modification in restricted areas (production) and manual creation of versions for modifications in less restricted areas (development). Complementary functionality to retrieve, review and restore older versions.

    • Audit trail

      All objects of any type under audit trail. All modifications to objects are tracked without manual registration and reportable. Content changes to clinical data can be tracked automatically, including comments and reasons.

    • 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.

    • Electronic Signatures

      Configurable electronic signatures for specific actions, including optional or mandatory comments. Signatures are reportable and associated with the respective objects and activities, and cannot be modified or deleted by any means.
Metadata Management
    • Standards Governance

      Model-agnostic governance of data models on attribute level for any data model including EDC, SDTM and ADaM. Supplemental inclusion of value level metadata and controlled terminology. Inheritance and linking foster reusability of standards among different levels. Versioning, change management processes and impact analysis support the lifecycle management of standard data models.

    • CDISC Compliance

      Ensures full compliance with any published CDISC standard, while running any proprietary custom checks at the same time.

    • Study Setup

      Interface to EDC systems for creating forms from metadata, with CRF preview capabilities before export. Import after data collection and compare are fully supported.
    • Operational Standards

      Creation of metadata packages for all downstream processes or users requiring standards. Generation of mapping specifications in Microsoft Excel or define-like formats for exchange.

Data Management
    • Mapping

      UI-based point and click definition of mapping specifications based on metadata. Automatic application of algorithms from standard libraries based on matching rules. Increased reusability based on standard mappings and templates. Generation of executable mapping programs and human-readable reports and specifications. Less need for programming skills.

    • CDISC checkers

      Built in SDTM and ADaM checks for compliance with all published CDISC versions. Supports inclusion of custom checks. Includes available controlled terminology like MedDRA and WHODrug. Includes checks on value level metadata and supplemental qualifiers.

    • ODM Validator

      Checks for compliance with ODM standard.

    • Reconcilliation checker

      Offers sophisticated checking capabilities for any kind of data reconciliation.

    • Spotfire Integration

      Push data into TIBCO Spotfire® from entimICE or pull data from entimICE while working in Spotfire for industry standard visualization of your clinical data.
Program Development
    • Statistical Programming

      Built-in feature-rich editors, including syntax highlighting for SAS, R and SQL. External editors configurable based on user preferences. External program development directly on the repository with native tools, using Enterprise Data Access.

    • Program Execution

      Built-in execution facilities utilizing central servers for SAS, R and SQL. entimICE metadata information made accessible for program code at runtime via macro or environment variables. Optional use of parameters and different value sets to efficiently re-run programs on different data. Direct access to generated log and output files.

    • Traceability

      Automatic execution trace for each SAS, R and SQL execution including inputs used and outputs produced. Automatic detection of outdated outputs and the ability to re-run the relevant programs.

    • Use of Integrated or External Tools

      Internal editors with syntax highlighting and program snippet execution are readily available within the system, while it is just as easy to use any familiar third-party tools for program development and execution.

    • Automation Tools

      A scripting API is available for automation of routine tasks, and a batch box offers the capability to execute a series of programs, with configurable notification on succesful completion or error messages on an unsuccessful run.

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 Compliance Of Processes

    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 Administration 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.

Find out more about the entimICE DARE Product Suite

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.

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

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