Customer:

Bayer AG

Solution:

PHALIMS - Pharmacokinetic Laboratory Information and
Management System

Customer Profile

As the largest german pharmaceutical company, Bayer AG is represented by some 350 companies employing 117,000 people on all continents. The cornerstones of its business activities are in Europe, North America and the Far East.

Project Goals

In the past few years, the number and the complexity of pharmacokinetik (in-vivo and in-vitro) and toxicokinetik studies have increased enormously. The amount of data and results which results from such studies have also correspondingly increased and cannot be handled any more without process oriented electronic data processing.

The currently available LIM systems on the market are predominantly sample oriented, which are used for example in the production or the stability control. These systems do not allow to apply an inspection plan for the definition and control of experiments.

Available on the market are also study oriented systems, which however only offer solutions for partial aspects. They either support only "ADME" studies (Absorption, Distribution, Metabolism, Excretion) or only toxicokinetik and bioanalytical studies or only studies to quantitative whole-body autoradiography or only in-vitro studies. None of the currently available systems unite all these research processes.

For this purpose as well as out of economic and quantitive reasons decided Bayer AG to start a development with the goal of covering these various requirements with a single system.

Solution Advantages

The advantages, which emerge through the use of such a system are quite obvious: All data is available in a single system, which simplifies the data access, and improves the integrity and quality of the data. As an additional affect is achievement in the reduction of costs for training, maintenance and support.

The multiple planning of experiments in diverse systems and the manual, respectively automated copying of data between various systems can be omitted.

PHALIMS covers the complete functional range, which is necessary for carrying pharmacokinetik studies. The multilingual Client-Server application consists of multiple - also individually applicable - components.

PHALIMS represents an integrated approach and unifies a modular concept with a flexible data model. The system can be easily extended or can be adjusted to changing basic conditions. PHALIMS is being deployed in the areas of pharmaceuticals and crop protection and fully complies with the technical requirements of GxP and of 21 CFR part 11.

Entimo Role

• Consulting
• Specification
• Implementation
• Installation
• Support
• Further system development

PHALIMS – zentralisierte Lösung für PK-Studien (only in German)

Article in Chemanager industry newspaper
Edition Nr. 8, 17.4.2003

( If you need Adobe Acrobat then click here)