Case Study

Advarra Consulting Delivers Clinical Trial Management Oversight

A mid-sized clinical research and development medical device organization was engaged in conducting clinical studies in complex therapeutic areas as well as establishing the infrastructure for the conduct of global clinical trials (under investigational new drug (IND) submissions in the U.S.) using an approved, commercially available device in combination with a Food and Drug Administration (FDA) approved drug.  In this case study, learn how Advarra Consulting: 

  • Provided comprehensive clinical quality services
  • Enabled compliance with good clinical practice requirements
  • Assessed and mitigated study startup risks
  • Identified key issues in clinical operations and clinical trial management processes

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Duration: 1 hour

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