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