Mission

As a high-performing data repository, entimICE DARE offers a completely new analytical experience for statisticians and data scientists. With Teradata or Hive backend, DARE is able to integrate even Real World Evidence data as well as other data sources like financial or safety data into clinical analysis. The solution allows the user to query, transform and pool data, develop and run ad hoc and standard programs, produce regulatory and management reports as well as submission packages in a fully controlled and traceable manner.

Benefits

  1. Fast load performance
  2. Version control for data with restore
  3. Regulatory compliant audit trail
  4. Incremental updates
  5. Support of views and snapshots
  6. Role-based access down to records
  7. Data blinding facility
  8. Configurable workflows
  9. Direct access to metadata
  10. Big data support
  11. Scripting API for automation

 

 

What's new

  • Enhanced metadata conformance control of productive data
  • Interface with Pinnacle 21 Community edition (OpenCDISC Checker)
  • Enhanced TIBCO Spotfire interfacing
  • Better traceability with access control, deputy and notification reports
  • Background import for large data volumes

 

 

Clinical Data Repository Highlights

Fast load performance

With a large number of ongoing trials, full data load can result in numerous loads every day and thus impact trial performance. Incremental loads are an efficient way to reduce this load. Use of incremental loads is the native way that an entimICE-based operational data warehouse works in production. Event-driven updates push forward the actuality of data to the level of the source system. This allows the EDC system and the analytical platform to be kept in synchronization, and analytics on the latest data can be run independently from the EDC.

Data privacy and data restrictions

entimICE DARE contains a dedicated component to manage access rights, roles, groups and users across the whole product suite. The access rights and roles managed in DARE can be applied on the data level (database schema) and on the file system level. The data access control is applied irrespective of the analytical tools used and this eliminates the risk of accessing unauthorized data. In addition, the system holds a detailed record of who ran which query against the repository. Based on the statistics available in the system, audit questions can be answered in a timely, validated and robust manner.

Flexibility through a dual storage concept

A unique characteristic of the entimICE platform is that the solution supports a hybrid storage concept with database and file-based repositories. Both storage types offer a similar functional scope and user experience. Users have the flexibility and convenience of using datasets, database tables, or a mixture of these to store and access data, depending on their needs.

 

Configurable and robust governance

The integrated solution handles large data volumes without compromising the governance process. In addition to the temporal function on data, the entimICE toolkit provides for version control for all other object types such as programs, metadata, documents and reports, to mention a few. Integrated tools allow users to tag or retrieve versions or to compare objects and versions by using a built-in comparison tool. The system supports the configuration of lifecycles for all repository elements by using the dedicated functionality of the application package. Changes to lifecycle and workflow states can automatically trigger other actions or notifications – this is a powerful communication tool, particularly for distributed teams, which keeps them up-to-date.

Metadata and standards re-usability

entimICE DARE contains a tightly integrated metadata repository that supports governance for such metadata types as data models, specifications, analysis and reporting metadata as well as a variety of other metadata types. The solution provides powerful tools to create, extract, collect, manage, link, search and exchange metadata. Due to this flexibility, the environment easily handles standardized metadata such as CDISC models as well as company-specific data models. A key aspect of the metadata repository available in the application is its tight integration with down-stream processes. Metadata are used for the transformation of data to different CDISC formats (e.g. from CDISC CDASH into CDISC STDM), for data validation and checking of SDTM compliance and numerous other functions. The metadata repository is accessible from reporting programs running in the analytical tools, thus supporting the re-usability of metadata and standards in the reporting process. In conjunction with the high-performance backend, the offering is unique in the market and will lay the foundation for future-oriented analytical solutions.


Download the fact sheet entimICE DARE CDR | SCE  or learn more about entimICE DARE product.

Data and metadata

Data and metadata

Create views

Create views

Data grid

Data grid

Version control

Version control

Audit trail

Audit trail