Our experienced Clinical Research Associates (CRAs) work effectively with sites — on-site or remotely — to ensure the study protocol is followed, informed consent is correctly obtained, adverse events are reported, accurate records are maintained, and study drug or devices are accounted for.
Our monitoring services include traditional, full-service monitoring as well as risk-based approach. CTC has both office-based and regional CRAs.
Our dedicated Clinical Trial Assistants (CTAs) will work in close collaboration with all project team members and with each Sponsor to ensure the Trial Master File (TMF) is up-to-date and inspection ready.
- Monitoring visits including site initiation, routine monitoring visits, and close out
- Risk-based monitoring
- On-site and remote monitoring (centralized)
- Monitoring plan
- Site Management support to ensure site regulatory compliance and adherence to the clinical study protocol
- Site training
- Co-monitoring visits
- Investigator Site File (ISF) set-up
- Trial Master File (TMF) set-up
- TMF management and quality control
- Support to CRM and CRA