Clinical start up and monitoring

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

Our project start-up and monitoring services include:

 

  • Site selection (pre-feasibility and feasibility assessment, pre-study visits);
  • Submissions of project documents to Regulatory Authority(-ies)/Ethics Committee(-s) (throughout the conduct of project);
  • Contract negotiation process handling;
  • Set-up activities of project sites;
  • TMF/eTMF maintenance;
  • Site initiation visits;
  • Site monitoring visits;
  • Provision of ongoing oversight and support to project sites throughout the conduct of a project;
  • Provision of support of Clinical Trial Coordinator for project sites;
  • Close-out visits;
  • Post-project support activities.
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