Determining the extent and nature of monitoring is a delicate balance of many considerations including objective, purpose, design, complexity, blinding, size, and endpoints of the trial. In general there is a need for on-site monitoring, before, during, and after the trial; however, central monitoring in conjunction with procedures such as investigators’ training and meetings and extensive written guidance can ensure appropriate conduct of the trial in accordance with GCP.
Onorach have a wealth of experience of all types of monitoring and can use this to build a robust and effective monitoring programme for clients.
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