Dossier support team is fantastic - they have a great team 5. Dossier team stays current with all our needs.
DOSSIER REVIEW PRO
The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints. In my opinion, Dossier is the best program by far for many reasons. Take a gander at over 50,000 verified reviews. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. We could give you a million and one reasons to try our (amazing) perfumes, but sometimes it’s best to hear straight from the source. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising.
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