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.