Clinical Research Monitoring

Monitoring is the act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements.

A Clinical Research Associate (CRA) is a profession defined by Good Clinical Practice guidelines (ICH GCP). While ICH GCP uses the term "Monitor" instead of CRA, the two terms are synonymous. The main function of a Clinical Research Associate is to monitor clinical trials.

Services we offer

  • Site management and monitoring of clinical studies according to SOPs, ICH Guidelines and GCP and/or ISO
  • Implementation of project plans as assigned
  • Clinical Site Visits
    1. Site Selection Visit (SSV)
    2. Site Initiation Visit (SIV)
    3. Site Monitoring Visit (SMV)
    4. Site Close-Out Visit (SCV)
  • Site visit reporting and follow up letter writing
  • Source data verification, data resolution
  • Drug accountability
  • Oversight of agreement negotiation / implementation
  • Oversight of Ethics Committee submissions
  • Patient enrollment management
  • Acting in the project role of as Local Project Coordinator or Lead CRA as assigned
  • Mentoring and training junior staff including co-monitoring visits and visit report review
  • Group process improvement activities including revision of SOPs

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