Design

Your Trial Design Is Your Regulatory Strategy. 

The endpoints, sample size, and analysis plan you lock in before enrollment define your path to approval. No amount of brilliant analysis fixes a flawed design after the fact.

What we bring:

• Scientific rigor — Right methods, not default ones. Proper endpoint hierarchy, realistic power calculations, decision rules that survive scrutiny.

• FDA alignment — We build agency expectations into the design from day one across 510(k)s, PMAs, IDEs, and De Novos. Less time on deficiency responses later.

• Operational feasibility — Designs grounded in real enrollment, dropout, and site constraints — not theoretical ideals.

What we do:

• Study design, sample size/power, SAP development, endpoint strategy, mock TLFs

• CRF review, database design consultation, data handling plans• Adaptive designs, Bayesian frameworks, propensity score methods, simulation modeling

A trial that isn't designed with the FDA in mind doesn't fail at submission — it fails at design.