Monitoring is the act of overseeing the progress of a clinical trial, auditing is a systematic and independent examination of the trial related activities and documents.
Monitoring Services:
Investigator-Initiated Clinical Trials
Assistance with developing Monitoring Plan
Tailored to protocol and risk base assessment
Full or Brief monitoring plan
Oversee the progress of a clinical trial
Source document verification
Ensure the study is conducted, reported in accordance with:
Protocol
SOP’s
GCP
All applicable regulatory requirements
Site visit and/or Remote monitoring
Pre-study qualification visit
Initiation visit
Interim monitoring visits
Close-out visits
Auditing Services:
Investigator-Initiated Clinical Trials
Clinical Registries
Assistance with developing Auditing Plan
Optional full or brief audit
Contact InformationIf you want more information about our auditing and monitoring services, please contact: christine.robins@curtin.edu.au