We persistently explore innovative and adaptative methodologies to fit local sites practice and optimize study team performance.

Clinical Monitoring

We provide a full range of services of clinical study monitoring including Clinical trials, Interventional and Non-interventional studies as well as Investigator Driven Studies.

The main objectives of the study clinical monitoring are to ensure that the rights and well-being of the human subjects are protected; the reported study data are accurate, complete, and verifiable from source documents; the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with Good Clinical Practices (GCP), and with the applicable regulatory requirements.

  • On site and remote Site Initiation Visits (SIVs);
  • Elaboration of SIV materials;
  • On site and remote Monitoring Visits;
  • On site and remote Close-out Visits (COVs);
  • Elaboration of SIV presentation materials;
  • Communication with study teams at sites;
  • Management of Adverse Events reporting.
  • Continuous management of the study database (EDC/eCRF).

For further information or to get a quote this service, contact us.