UBC outcomes research experts have vast experience collaborating
with regulatory agencies and understand the requirements associated
with patient-reported outcomes (PRO) claims and labeling. We develop
strategies early during the clinical development process to
anticipate potential hurdles and provide solutions that will lead to
success.
Our services include:
- Position papers and manuscripts to address standards of evidence
for labeling and promotional claims
- Expertise on regulatory requirements for PRO data
- PRO evidence dossiers, including:
- Rationale for measuring PROs and instrument selection
- Documentation of psychometric characteristics
- Summary of randomized clinical trials results
