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- Critique scientific quality of unpublished documents, existing questionnaires or analytical methods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 existing PRO measures
- Develop original PRO measures based on state-of-the-art approaches following the recent final FDA guidance document, incorporating patient and provider input using In-depth patient/clinician interviews
- Conduct patient focus groups
CROSS-CULTURAL ADAPTATION/TRANSLATIONS (via a partner)
- Develop and test cross-culturally adapted PRO questionnaires
- Forward and back translations
- Cognitive debriefing
- International harmonization
QUESTIONNAIRE VALIDATION
Evaluate measurement properties of PRO measures:
- Variability
- Reliability
- Validity
- Responsiveness
- Interpretability (e.g., MCID/MID)
TRIAL-BASED SERVICES
- Recommend best approaches for implementing outcome research 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)
- Prepare manuscripts of study findings
THERAPEUTIC AREAS
HOS has extensive experience in a variety of therapeutic areas including, but not limited to, oncology, cardiovascular, central nervous system, rheumatology, endocrinology, gastroenterology, respiratory, and women's health.
READ ABOUT OUR THERAPEUTIC AREA EXPERTISE >
