Rare Disease Expertise from Consultation to Submission
Rare Disease trials present additional unique challenges and opportunities. We help determine if your study qualifies for an accelerated regulatory approval pathway – including Orphan Drug Designation, Fast Track Status or Priority Review – and we’ll represent you at US Food & Drug Administration (FDA) and European Medicines Agency (EMA) meetings.
Veristat ensures that your clinical trial or program design supports your regulatory strategy, disease progression analytical models or previous adult trials. Our experts can help you explore and simulate adaptive trial designs. Then, we find, recruit and engage the patients and sites through to study completion. Lastly, we analyze the data and prepare your submission for regulatory agency review.