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distinguishing features, entimICE^® DARE tracks dependencies between objects involved in the analysis process, reports outdated ones and supports workflow definition.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Automated reporting of outdated objects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

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