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
