Services
PRO Dossier
PRO Dossier services include the development and management of a PRO Dossier. This service includes a structured review of a PRO instrument or set of instruments, which results in comprehensive documentation about the measurement properties and regulatory compliance of the implementation. PRO Dossier provides documentation of the PRO strategy and instrument(s), which would be submitted at the time of filing or at other appropriate points where assessment strategies are being discussed (e.g., end-of-phase-II meetings).
PRO Dossier services include:
- Expert development of comprehensive documentation for a PRO strategy and instrument(s) that can be submitted to regulatory agencies independently or as part of an application (e.g., NDA).
- The PRO Dossier is built from one or more of the following:
- literature reviews
- reviews of study protocols
- analyses of PRO data from sponsor trials
- SBA reviews
- consultation with sponsor experts and key opinion leaders