CETERA provides a full range of services considering the 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