statsby.ai

Statsby is a pharma-native AI and Data company. We work with pharma sponsors, biotechs, and clinical research organizations on the work that defines a trial — the protocols, statistical analysis plans, study reports, regulatory submissions, and the data that flows through them. We're a team of problem solvers who believe the next generation of pharma breakthroughs will come from blending deep domain expertise with AI that's engineered for regulated environments — where auditability, traceability, and scientific rigor are the baseline. That belief shows up in everything we ship. Our platforms — Revectra and Veractra Revectra is AI-powered protocol-to-platform intelligence. It turns clinical trial protocols — new and legacy — into structured, version-controlled CDISC USDM 4.0 study definitions, exposes them to downstream systems via API, and generates study documents with AI. Purpose-built for teams adopting Digital Data Flow. Veractra is AI-powered Clinical Study Report generation that medical writers, reviewers, and regulatory teams can trust. ICH E3-compliant CSRs in days — every numerical claim verified against source TLFs, every sentence traceable to its origin, deployed entirely on your cloud. Our Data & AI consulting We partner with pharma sponsors, biotechs, and CROs to design and ship production-grade Data and AI systems — across data engineering, Generative AI, MLOps, and AI strategy — delivered by teams who understand clinical and scientific workflows as deeply as the technology that powers them. If you're exploring our platforms, a consulting engagement, a partnership, or a place on the team, we'd be glad to connect. → statsby.ai