DARE

Data Analysis and Reporting Environment is a validated, fully GCP and CFR Part 11 compliant data analysis and reporting solution that facilitates statistical programming and data management in a repository-based, fully integrated, controlled and traceable environment.
The solution integrates available programming data sources and tools and provides for audit trails, versioning, date stamps and electronic signatures along the entire study lifecycle thus guaranteeing compliance with demanding regulatory requirements. 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distinguishing features, entimICE® DARE tracks dependencies between objects involved in the analysis process, reports outdated ones and supports workflow definition.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. A role-based model allows easy administration of the solution.

Overview of Key Features

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)

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• Automated reporting of out-of-date objects

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)