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entimo is a life sciences and regulatory informatics company which provides pharmaceutical, biotechnology
and crop science companies, contract research organizations and medical device manufacturers as well as the
relevant regulatory authorities with high quality
software products and services.
Products
entimo offers software solutions which help
to streamline R&D processes of our customers:
DARE:
Data Analysis and
Reporting Environment for fully controlled, traceable and
regulatory compliant process in clinical trials.
MAPPING:
Mapping program and specification generator for
easy data conversion to CDISC and custom data models based on metadata definitions.
Define.xml
Generator: Creates
define.xml |
define.pdf
(CDISC
CRT-DDS)
with a few mouse clicks from metadata-based element definitions.
ADaM
Checker/SDTM Checker:
Validated
SAS® programs
ensure data ensure data consistency and compliancy with standards
with standard and user-defined checks.
ODM Validator:
Java based tool for
content and structure validation of ODM files
including define.xml with 400+ built-in checks
Electronic
Test Cases
(ETC):
Automatic test environment for operational qualification (OQ) and performance qualification (PQ) of SAS macros
and programs.
In the pre-clinical area our product line includes:
ToxKin:
Validated software package for the non-compartmental analysis of toxicokinetic and pharmacokinetic studies.
PhaLIMS:
Laboratory Information Management System (LIMS)
supporting in-vivo and in-vitro as well as radioactive and non-radioactive studies.
Our clinical products as well as ToxKin are based on the
entimICE®
platform -
GCP
and 21 CFR Part
11
compliant, modular e-clinical solutions suite.
Professional Services
Professional Services for individual customer projects are a key element of entimo AG's core competencies. Find out more about our professional
services here
Quality and trust
entimo commits to superior quality products as well as flexible and
reliable services which meet our customer's needs. Our ISO 9001:2008
certification and resulting obligation to continuous monitoring of
performance standards and constant improvement of our processes
means that our customers can be assured they receive the highest
level of support in the areas of data acquisition, monitoring, data
analysis and reporting as well as in the optimization of their
business processes through our software solutions.
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News and events
Use Case
Standards Governance with entimICE
d-Wise and
entimo Enter into Strategic Partnership
DIA
EuroMeeting
2012
(26-28
March 2012, Copenhagen,
Denmark)
CDISC
Interchange
EU
(18-19
April 2012,
Stockholm, Sweden)
[more...]
Some of our industrial customers
 
Regulatory authority customers
BfArM (Federal Institute for Drugs and Medical Devices)
BfR (Federal Institute for Risk Assessment)
Friedrich-Loeffler Institute - Federal Research Centre for Virus Diseases of Animals
[more...]
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