Clinical monitoring

• Who we are
• What we do and what you get

Who we are

The Clinical Monitoring core team comprises a group of about 10 qualified and trained clinical monitors located in Eschborn who are able to coordinate and monitor all aspects of a clinical trial and who are working closely together with the Clinical Operations group.

The core team is supported by dedicated local professionals all over Western and Eastern Europe as well as the USA and South Africa.

Qualifications: Qualified medical documentalists, nurses, BScs.

Experience in clinical development: About 4 years on average with individuals who have up to 9 years of experience.

What we do and what you get

Clinical monitoring requires working to the highest standards of quality, adhering to ICH GCP, local regulations, and sponsor or Accovion SOPs. In order to maintain this high level of quality we have implemented a training programme for clinical monitors. In addition emphasis is given to ensure that our clinical monitors have a good understanding of our internal data processing, as the seamless interaction between clinical monitors and data management is essential for a rapid and efficient data cleaning process. However, monitoring is also offered to clients as a stand-alone service.

Our clinical monitors provide:

• Monitoring during all phases of a clinical trial:
  • Site selection and feasibility
  • Site assessment and pre-study visits
  • Site initiation
  • Regular monitoring, including
    • source data verification (paper CRF or EDC)
    • study drug handling and accountability
    • supervision of AE / SAE reporting
    • checking the investigator study file
    • data processing and query handling
  • Telephone monitoring between the visits
  • Close-out visits
• Site management
• Training of site staff and ongoing support of study site activities in order to ensure a regulatory and protocol compliant study conduct
• Creation of an efficient cooperation between the trial site and the Accovion project team

In addition the Clinical Monitoring team in Eschborn in cooperation with Clinical Operations provides:

• Supervision and training of clinical monitors
• Continuous quality control by co-monitoring and regular meetings/TCs
• Generation of study-specific monitoring documents
• Presentations at monitor and investigator meetings
• Preparation and implementation of SOPs and working procedures