Consulting, Clinical Trials and More...

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