Products and Services

Health Outcomes Solutions provides a full range of services for PRO studies, from designing studies and developing original measures to analyzing PRO data and preparing manuscripts. We have all of the necessary capabilities to successfully and efficiently conduct outcomes research.

  
Strategic Planning and Study Recommendations
Expert consulting on FDA guidelines, endpoint selection, and study design
Develop Outcomes Research strategic plans
Participation on thought leader advisory panels
Plan and convene PRO advisory panels
Develop study protocols
Critique scientific quality of unpublished documents, existing questionnaires or analytical methods
PRO Questionnaire Development, including preference-based measures
Identify and critique appropriate existing PRO measures
Develop original PRO measures based on state-of-the-art approaches following the recent FDA draft guidance document, incorporating patient and provider input using In-depth patient/clinician interviews
Focus groups
Cross-Cultural Adaptation/
Translations
Develop and test cross-culturally adapted PRO questionnaires
Forward and back translations
Cognitive debriefing
International harmonization
Questionnaire Validation
Evaluate psychometric properties of PRO measures:
   Variability
   Reliability
   Validity
   Responsiveness
   Interpretability
   (e.g., MCID/MID)
Trial-based
Services
Recommend best approaches for implementing OR studies
Develop implementation materials
(e.g., Protocols, IRB Submission Materials, Recruitment Materials, Training Guides, CRFs/Patient Diaries)
Oversee training of sites for PRO studies
Conduct site and patient recruitment
Manage PRO and ePRO data collection
Analysis and Reporting
Provide statistical consultation
Develop statistical analysis plans
Analyze and interpret PRO data
Communications
Prepare executive summaries and detailed reports of study findings
Develop materials for submission to regulatory authorities
(e.g., PRO dossiers and briefing documents)