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Three reasons to use entimICE DARE:

1. All information and programming tools in one place

2. Improved team communication

3. Regulatory compliance of your processes

 

entimICE DARE

Data Analysis and Reporting Environment is a statistical computing environment that facilitates statistical programming and data management in a fully controlled and traceable manner.
The solution integrates available programming data sources and tools in a central repository and provides for audit trails, versioning, date stamps and electronic signatures along the entire study lifecycle. Among other distinguishing features, entimICE® DARE tracks dependencies between objects involved in the analysis process, reports outdated ones and supports workflow definition. This controlled approach provides a high level of data transparency and clarity.

Overview of Key Features

Metadata and data management

  • Clinical data and metadata repository

  • Easy connectivity and direct access to various external sources (EDC, CDMS, EDMS, JReview)

  • Support of numerous formats (e.g. SAS, XPT, CSV, ODM, XML, XLS…)

  • Derivation of metadata from existing data sets

  • Check of data against metadata

  • Semantiv search engine

  • Advanced management of codelists and formats

  • Support of standard medical dictionaries

Programming

  • IDE for SAS, R and S-PLUS

  • Numerous external editors seamlessly supported

  • Easy program parameter management

  • Online, batch and scheduled job execution

  • Full execution tracing informationg

Reporting

  • Study progress reporting

  • Interactive dashboard for study progress reporting

  • Impact analysis report

  • Ad hoc queries for data exploration

  • Numerous administrative reports

  • Report publication to EDMS (e.g. Documentum)

  • Automated reporting of outdated objects

Lifecycles and workflows

  • Configurable lifecycle management

  • Automated, graphic workflows

  • Task assignments

  • Study planning and close-out facilities

  • Definition of links and dependencies

  • User notification and messaging service

  • Final run support

Full traceability and transparency

  • Audit trail with human readable reports 

  • Complete object history and full log of user actions

  • Version management

  • Definition of protected areas with check-in/check-out functionality

  • Easy reconstruction of past states

Regulatory compliance

  • Fully compliant with FDA 21 CFR Part 11 and ICH GCP regulations

  • Support of the latest CDISC standards:
    ODM | SDTM | CRT-DD (define.xml)

Administration

  • Easy role-based access right definition

  • Online system configuration

DARE is based on the entimICE® platform - entimo’s GCP and 21 CFR Part 11 compliant, modular and controlled e-clinical solutions suite – and effectively meets your needs due to the flexible combination of provided features.

Click here to download this page as entimICE DARE flyer.

 

What is new?

In the latest release, new features include:

Numerous data warehouse improvements

Direct execution of custom SQL

Easier synchronization of data in data warehouse and file repository

Visualization of lifecycles

Comparison of object properties

Web interface improvements

Call program generation for multiple programs

Browsing of format catalogues

Metadata mapping

BRIDG support

Download Fact Sheet

MDR | CDR | SCE

Request info more about entimICE DARE here...

Learn more about entimo's solutions in our case studies here...

 

 

The development of this product has been partially co-funded by the European Funds for Regional Development (EFRD)

 

 

 
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