Clinical teams and sponsors want to know what FDA and other regulators will ask when they review protocols, statistical analysis plans (SAPs), briefing documents and clinical study reports (CSRs). Drawing on our experience as CDER biostatistical reviewers, we:
Bring us in while documents are still in draft. Early input helps teams hit internal deadlines and can reduce the number of interactions needed with regulators.
Ahead of regulatory meetings, we help teams prepare responses to the questions they expect, and to written feedback from regulators. Lisa Kammerman has taken part in mock FDA meetings, bringing her experience as an FDA team leader and reviewer and as an industry statistician.