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

BERLIN -- (MARKET WIRE) -- 02/28/2006 -- 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

About entimo

entimo is a provider of innovative "e-R&D" products and professional
services to the pharmaceutical and agrochemical industries. The firm
also is a recognized supplier of quality IT solutions to the European
regulatory authorities. entimo's dedicated staff of software
professionals has developed and maintain several custom solutions,
such as CDMS (Clinical Data Management System), LIMS (Laboratory
Information Management System) and clinical portals, for large
pharmaceutical and crop science as well as regulatory authority
customers. Bayer Healthcare AG, Bayer Crop Sciences AG, Schering AG,
Boehringer Ingelheim, Altana Pharma and BfArM are just some of its
customers that have an established and long-term relationship with
them. Founded in August 2002, entimo AG is a privately held company
with global headquarters in Berlin, Germany. For more information,
please visit the company's website at www.entimo.com.
Contact:
Dimitrios Karadimas
dk@entimo.com

SOURCE: entimo AG