Monitoring is the key link between clinical routine and GCP-compliant clinical research. A trial’s success or failure depends largely on the quality of monitoring, and the study duration is greatly influenced by it.

We set high standards for the professional qualification of our monitors. All MEDIDATA monitors have a medical/scientific background and undergo several months of training before taking over management of study sites. The average monitoring experience of our in-house and field based CRAs is >6 years, and some have up to 15 years of experience. Our CRAs routinely use EDC systems and a range of web-based tracking and reporting tools. Continuous documented trainings are mandatory.

MEDIDATA has acquired a broad experience through the management of a large number of trials of various phases, sizes, and indications. This includes complex oncological studies for FDA submission as well post-authorization studies with optimized activity plans.

The high level of professionalism is ensured by our CRAs’ degree of training, and maintained by the combination of challenging project management and monitoring tasks. We consider this the key to our exceptionally low fluctuation in monitoring staff, which in turn is vital to competent and high quality monitoring throughout a project’s course.

MEDIDATA's key monitoring competence covers all German- and English- speaking countries. A net of experienced partner CROs is relied on for the monitoring of other European countries.

Our clinical monitoring service includes:

• Site selection and feasibility evaluation
• Pre-study qualification visits
• Support for contract negotiations
• Compilation of documents needed for ethical and regulatory approval
• Site initiation
• Regular monitoring visits (including source data verification, drug accountability, supervision of AE/SAE reporting, investigator site file check, and data query handling)
• Telephone monitoring in between visits
• Close-out visits
• Site management (including overall support in all study-related questions, assistance with study supply management, reimbursement, and training of study site staff)