FIDAM / Clinical Research

Objective 

At the Research Institute of the Diabetes Academy Mergentheim (Forschungsinstitut der Diabetesakademie Mergentheim) a study center is established. This study center is dedicated to the planning, conducting and evaluation of not only our own clinical studies, but also clinical studies from contracted research institutes and the industry. The conducted clinical studies occur in accordance to the guidelines of the law governing the manufacture and prescription of drugs (Arzneimittelgesetz-AMG) or the law of medicinal products (Medizinproduktegesetz-MPG). International standards of security of a highly ethical quality are decisive for the conducting of the studies, such as defined in the Declaration of Helsinki and expressed in the program of a good clinical practice-GCP.

The study center of FIDAM is open to all studies of Phase II-IV and works together with clinical specialist departments of the Diabetes Center Mergentheim as well as industrial partners. Biometric evaluations of the studies also belong to the performance spectrum of the study center.

 

FIDAM strives to have a focal development in the area of multicentral clinical studies for medicinal products and multicentral examinations of medicine from the area of diabetology.

 

 

Quality Security

A quality management system (certified according to DIN EN ISO 9001:2000) based on the Standard Operating Procedures (SOP) is in progress.

 

Contact

haakdiabetes-zentrum.de