STUDY MONITORING

Our dedicated team of clinical monitors / CRAs has many years of experience in clinical and technical studies.

Our monitoring service includes:

  • Establishment of the study documentation (TMF) and monitoring plan, preparation of CRFs and training material
  • Study site supply with all study material
  • Site initiation and training of the study team
  • Detailed monitoring of the clinical trials (On-Site/Remote) and reporting to the sponsor
  • Source data verification (SDV)
  • (S)AE/(S)ADE-documentation and -reporting
  • Study close out
  • Post-Market-Surveillance