entimo AG Ushers in New Era of Clinical Data Repository-Based Data Analysis and Reporting Environments

Paris – 06/03/2006 – entimo AG, a leading company providing manufacturers of the pharmaceutical and crop science industries with high quality e-business Research & Development (eR&D) products and solutions, as well as custom IT solutions for the regulatory authorities, today announced the general availability of its flagship product entimICE DARE to all customers worldwide.

entimICE DARE is a comprehensive and flexible product that ensures seamless operation across different stages of clinical development by enabling the user to view, manage, analyze and report data across clinical applications, and across projects or trials, within the same environment, and in a regulatory compliant manner. entimICE DARE is designed to meet the needs of clinical research and development personnel - such as clinical monitors, clinical research associates, biostatisticians, programmers, etc. - involved in the integration, management, analysis and reporting of clinical trial data. Now pharmaceutical companies can have a customizable repository based data analysis and reporting environment that is cost effective, easy to implement, and tailored to their business - all without having to write a single line of code.

"entimICE DARE is filling the gap of traceability between CDMS and submission in a customizable manner" said Juergen Spieler, chief executive officer of entimo AG. "With this release, entimo AG raises the bar for clinical data repository based solutions for managing, analyzing and reporting of clinical data, delivering pharmaceutical companies unprecedented value. The enhanced functionality that our entimICE DARE solution provides enables pharmaceutical companies of all sizes to meet the increasing demands of regulatory compliance, such as GxP and CFR Part 11, head-on, while providing them the flexibility to customize their solution based on their unique business requirements."

entimICE DARE provides:

General features

• Uniform and customizable environment for clinical data building, analysis and reporting (cross trial and individual level)
  
• Global metadata repository
  
• Integrating SAS
  
• Easy to use graphical user interface
  

Regulatory compliance

• 21 CFR part 11
  
• GCP
  

Secure access

• Secure login-ins
  
• Allocation of users to roles (general or e.g. only in a specific study)
  
• Role based access right definition
  
• User and role administration by privileged users
  
• Allocation of electronic signature for actions
  

Structure definition

• Structure definition and administration features (e.g. different study and project types)
  

Traceability

• Audit trail for objects (according to structures, access rights, contents)
  
• History of objects
  
• Versioning of objects
  
• Action log (executed user actions)
  
• Program execution trace (parameters and their used values, input objects, output objects)
  
• Electronic signature
  

Workflow

• Definable with structure administration feature (e.g. status values based action execution)
  
• Test and production environments
  
• Metadata management
  
• Metadata for all data objects
  
• Data can be allocated to metadata
  
• Check, check-in, check-out of data based on related metadata
  
• Regimented and audited changes of metadata, follow-up changes of depending data
  

Data management

• Import/export of different data object types (SAS, Oracle.)
  
• Browse and edit features
  
• Transformation, reporting, analyzing using company standard and / or user programs
  

Statistical analysis and program management and execution

• Program creation and maintenance with the help of special editors
  
• Optional definition and description of program parameters
  
• Execution in dialog and/or batch with parameter setting
  
• Program rerun support
  

For more information, please visit the company's website at www.entimo.com.