About Us...

Monitoring Systems, Wolfgang Feth GmbH, was founded as a contract research organisation (CRO) in 1993. It supports pharmaceutical companies in developing new drugs, drugs pending approval and approved drugs.

We offer to perform one or more of a sponsor trial-related tasks and functions.

Our service portfolio includes:

Science consulting (planning and conducting phase I – IV clinical trials on new or approved drugs)
Coordinating, monitoring and evaluating clinical trials:

Recruitment of trial sites / investigators
In house activities for implementation of clinical trials (medical writing and/or CRF-design)
Submission of trial protocols for approval by EU and local authorities
Organisation of investigators’ meetings
Investigator payment in line with the study’s progress
On-site monitoring in all trial centres during the clinical phase of the trial in accordance with the sponsor’s SOPS (Standard Operating Procedures) or monitoring systems and in compliance with ICH-GCP and German Drug Law (AMG)
Auditing (protocol, trial master files, on site)
Management and distribution of clinical trial materials
Data cleaning, query management, evaluation, biometric reporting and final reporting

Investigator training in ICH-GCP and in special study items (e.g. investigators’ meetings)
Monitor training in sponsor´s SOPs and ICH-GCP in accordance with German Drug Law


	Consulting, Clinical Trials and More...