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

Clinical study management & Monitoring

CETERA provides a full range of services considering the clinical study management and monitoring of Clinical Research including Clinical trials, Interventional and Non-interventional studies as well as Investigator Driven Studies. Our responsibilities are set out in the International Conference on Harmonization of Good Clinical Practice (ICH-GCP) guidelines 5.18

The main objectives of the study management 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 GCP, and with the applicable regulatory requirements.

  • Feasibility: site assessment, selection and identification;
  • Investigator Contract Negotiation;
  • Study Full Regulatory Submission;
  • Clinical Monitoring;
  • Project Management;
  • Medical Monitoring.

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