A Global CRO

 

Clinical Monitoring

Amarex employs highly experienced CRAs who are trained according to ICH-GCP and offer therapeutic expertise and clinical research experience. Our CRAs are site managers which helps to ensure strong monitor-site relationships. Amarex provides an array of clinical monitoring services to support trials around the world. Our decentralized workforce allows us to maximize flexibility, reduce travel costs, and create an efficient and cost effective process.

CRAs will manage site visit objectives, including:

  • Ensuring signed informed consent forms
  • Source Data Verification (SDV), based on the protocol and study plans
  • Reviewing all eCRF/CRFs and discuss trends with site staff
  • Evaluating eCRF/CRFs for serious adverse events
  • Performing drug accountability
  • Reviewing investigator study files for completeness
  • Ensuring protocol compliance
  • Encouraging and supporting sites