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distinguishing features, entimICE^® DARE tracks dependencies between objects involved in the analysis process, reports outdated ones and supports workflow definition.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

• Secure central repository

• Easy connectivity with external sources:
  EDC | CDMS | CTMS | EDMS

• Multi-level metadata

• Deriving of metadata from existing data sets

• Support of different data types incl. SAS transport files, Excel and XML

• Check of data against metadata

• Correction of dependent datasets

• Advanced browsing and search functionality including metadata search

Full traceability and transparency

• Audit trail with human readable reports 

• Complete object history and full log of user actions

• Version management

• Electronic signatures

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

• Reconstruction of past states

• Object planning feature

Program management and execution

• IDE for SAS and S-PLUS

• Numerous external editors seamlessly supported

• Easy program parameter management

• Online, batch and scheduled job execution

• Full execution tracing information

Workflow and notification

• Status-based workflow definition

• Task assignments based on object status

• User notification and messaging service

• Study planning and close-out facilities

• Final run support

• Study progress reporting

Object dependency management

• Definition of links and dependencies between objects (e.g. programs and data)

• Automated reporting of out-of-date objects

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.

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Further Info

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