Patient Reported Outcomes (PROs)

At MarksMan, we design and implement studies based on Patient reported outcomes (PRO) to fully establish a product’s real-world economic and clinical value. We have a highly experienced team to successfully and efficiently conduct outcomes research:

PRO questionnaire development

  • Identify and critique existing PRO measures
  • Develop original PRO measures based on FDA guidance
  • Conduct patient focus groups

Questionnaire validation

Evaluate measurement properties of PRO measures:

  • Variability
  • Reliability
  • Validity
  • Responsiveness
  • Interpretability (e.g., MCID/MID)

Trial-based services

  • Recommend best approaches to implement outcome research studies
  • Develop implementation materials (e.g., Protocols, IRB Submission Materials, Recruitment Materials, Training Guides, CRFs/Patient Diaries)
  • Manage PRO and ePRO data collection.

Analysis and validation

  • Provide statistical consultation
  • Develop statistical analysis plans
  • Analyze and interpret PRO data

Communications

  • Executive summaries and detailed reports of study findings
  • Materials for submission to regulatory authorities (PRO dossiers and briefing documents)
  • Manuscripts of study findings