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ISO Certification

ISO9001-2008 Certificate

Gold Member
(Star Member)

Jobs at entimo

Project Manager Clinical Data Management

Support Engineer IT Clinical Environment

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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.

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 201
2, Stockholm, Sweden)

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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

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