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.
Worried that you won’t select the right regulatory pathway, study design, or patient population? Trust the Veristat experts who have supported more than 580 clinical projects for rare disease therapies of which:
- Over 60% of the marketing applications we prepared are for rare diseases
- Over 250 oncology programs we supported are in rare cancers
- More than 200 rare genetic disease studies