Study Quality Risk Assessment reduces protocol amendments and increase study quality – e.g. at a midsized US based Pharma Company:

Protocol did not address the definition and reporting of accidental overdosing

Study included efficacy/safety assessments e.g. lab values, that may potentially un-blind investigators

  • Because these risks were detected before protocol approval, relevant adjustments were made and protocol amendments could be avoided


Trial Site Risk Assessment maximizes patient safety and data integrity – e.g. at a Large US based Biotech Company:

Management of Monitoring Action Items has been handled unreliably by a CRO

  • Complete and thorough review of the CRO site activities was conducted, resulting in the identification of a communication breakdown and its subsequent correction across multiple sites.