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