Clinical trial start-up and monitoring

While managing and overseeing the conduct of clinical trial at each trial site, our aim is to ensure that the trial is being conducted in full compliance to local regulatory and GCP requirements, as well as to requirements of our Clients. We are dedicated to follow the timelines established by our Clients for performance of each clinical trial-related task. Workload of our CRAs/SCRAs is closely monitored in order for AmberCRO Clients to receive high-quality data on ongoing basis.

Our clinical trial start-up and monitoring services include:

 

  • Feasibility and site selection;
  • Submissions of clinical trial documents to Regulatory Authority/Ethics Committee (throughout the conduct of clinical trial);
  • Contract negotiation process with trial sites;
  • Set-up activities of trial sites;
  • TMF/eTMF maintenance;
  • Site initiation visits;
  • Site monitoring visits;
  • Provision of ongoing support to trial sites throughout the conduct of clinical trial;
  • Provision of support of Clinical Trial Coordinator for trial sites;
  • Close-out visits;
  • Post-trial activities;
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