DEVELOPMENT

We develop clinical outcome assessments with the intended purpose of evaluating efficacy endpoints and, when appropriate, supporting labeling claims. We provide the following COA development services:

 

  • Development of relevant study documents and protocols
  • Institutional Review Board submission
  • Recruitment site training and management
  • Face to face concept elicitation interviews and focus groups with patients and caregivers
  • Key opinion leader and clinician interviews, as well as Delphi panels
  • Face to face cognitive interviews with patients and caregivers
  • Transcription of interview data
  • Coding and analysis of transcripts
  • Reporting of results, including associated recommendations