Regulatory Guidance and Support

FDA Qualification Process Experience
To develop novel PRO measures for use in future clinical trials for irritable bowel syndrome, we collaborated with the Critical Path Institute's PRO Consortium, three pharmaceutical sponsors, clinical experts, and the FDA. We are also collaborating with another client to support the revision and qualification of an existing measure.

We can support you throughout your regulatory negotiations.

Our team has negotiated with the FDA’s Clinical Outcome Assessments (COA) team and a wide variety of reviewing divisions on numerous occasions to select and support measurement strategies acceptable to the FDA following the release of the FDA’s PRO Guidance.

To support these efforts, we have developed more than 25 evidence dossiers, contributed to hundreds of briefing documents, and have accompanied clients to FDA meetings in support of their proposed labeling claims.

Our experts, particularly those based in Europe, also have significant experience liaising with the EMA to negotiate acceptability of COA-based endpoints for use in label claims, as well as guiding industry clients through the EMA’s PRO Scientific Advice and Biomarker qualification processes.