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Aligning the Art & Science of Clinical Research® is not just our tagline;
it represents our signature, collaborative approach.

Safety

Safety reporting is a critical component of clinical trial management. As a CRO, we are able to provide a full range of safety support services. Sponsors can rely on MedTrials to augment their internal teams or to manage medical monitoring, safety data review and regulatory reporting.

Services include:

  • Medical consultation: reviewing and evaluating event collection and reporting, data analysis, clinical study reports (CSRs), and regulatory submissions
  • Product safety: processing serious adverse event reports including evaluation of relatedness and analysis of similar events for expedited cases; identifying and evaluating safety signals, trends, and events
  • Site education: training study teams on disease states, treatments, protocol compliance, inclusion and exclusion criteria, procedures, and assessments
  • MedDRA coding
  • Safety narrative development
  • MedWatch reporting