MONITORING / DATA MANAGEMENT

Our team of clinical Monitors/CRAs and Data Managers has many years of experience in clinical and technical studies.

Our monitoring and data management services include:

• Study documentation (Trial Master File, TMF)
• Writing of monitoring plan
• Preparation of Case Report Forms (CRFs) and training material
• Study site supply with all study materials
• Site initiation and training of the study team
• Detailed monitoring of the clinical studies (On-Site/Remote) and reporting to the Sponsor
• Source data verification (SDV)
• (S)AE/(S)ADE-documentation and -reporting
• Study close-out