What we offer
We meet you where you are.
One platform, two ways to use it. Search the precedent yourself, or hand us the deliverable.
Ask & verify
Ground your program in precedent before you write a word.
FDA Precedent & Landscape Research
Search 500,000+ indexed FDA guidance documents, CRLs, and statistical reviews for your indication in seconds. See exactly which precedent supports — or challenges — your approach, every claim source-linked back to the original document.
SAP Templates from Comparable Studies
Start from a real SAP structure, not a blank page. Pull publicly available SAPs from studies matched to your indication, phase, and design as your baseline.
Power Calculations from Precedent
Run sample-size and power calculations grounded in the actual effect sizes and variability reported in comparable trials — a documented starting point, not a guess.
Generate & deliver
When you're ready for a deliverable, our team and AI system build it with you.
Protocol Review & Design
A single misaligned endpoint can trigger a Complete Response Letter and cost you a year. We stress-test your protocol against FDA guidance, CRLs, and precedent — flagging every gap before it reaches the agency.
SAP Review & Optimization
Under-powered trials fail quietly — sponsors discover the problem after the data is locked. We reassess your sample size, power, and analytic strategy against regulatory precedent so the statistics hold up at submission.
SAP Generation
Waiting weeks for a SAP draft while your timeline burns doesn't have to be the norm. We generate a complete, submission-ready SAP in days, every decision evidence-backed and reviewed by a credentialed statistician.
