Statsby Solutions is a specialized AI and Data company built exclusively for the pharmaceutical and clinical research industry. We combine deep domain expertise with engineering depth to deliver end-to-end data and AI capabilities - from purpose-built platforms like Revectra and Veractra to enterprise-grade Data Engineering, Generative AI, and Agentic AI consulting.
We work with pharma companies and CROs who have high-stakes data and documentation challenges - organizations where accuracy is non-negotiable, regulatory scrutiny is constant, and production-grade is the only standard that matters.
Our products are built by the same engineers who consult on your custom challenges. Our consulting is informed by the same domain depth that shapes our products. That's what makes Statsby different - solutions and services from a team that lives in this industry, not one that visits it.
01
AI-Powered Protocol-to-Platform Intelligence
Digitize every protocol - new or legacy - into structured, version-controlled CDISC USDM 4.0 study definitions. Centralize them. Expose them via API. Generate downstream documents - grounded in your data, deployed on your cloud.
02
AI-Powered CSR Generation
Generate ICH E3-compliant Clinical Study Reports in days - with multi-stage numerical verification against source TLFs, sentence-level traceability, and deployment entirely within your cloud environment. Purpose-built for medical writing, CRO, and regulatory teams.
03
Data & AI Consulting for Pharma and Clinical Research
Whether you're modernizing clinical data infrastructure, deploying Generative AI into regulated workflows, or exploring what agentic automation can do for your operations - we bring the engineering depth and domain focus this industry requires.
From legacy clinical data warehouses to cloud-native lakehouse architectures. CDISC-aligned, GxP-ready, built to scale.
RAG systems, knowledge assistants, and document automation grounded in your proprietary data - not the open internet.
Multi-agent systems for study start-up, PV case processing, submission assembly, protocol deviation management and more. AI that executes, under human governance.
We build the engineering backbone that keeps AI reliable, auditable, and continuously valuable in regulated environments - with responsible AI principles engineered into every layer. Your models, prompts, and agents stay safe, performant, and ready for inspection long after go-live.
Domain-native Data and AI consulting for pharma and clinical research organizations - from cloud-native clinical data platforms and production-grade Generative AI to multi-agent systems that automate complex regulatory workflows. Every engagement starts with strategy and alignment. Every engagement ends in production.
01
One industry. Everything we build, built for it.
Pharma and clinical research is our entire practice. That focus shows up in the speed our teams get productive on your data, the depth of our fluency with clinical standards and regulatory frameworks, and the design choices we make for the way your organization actually operates. You get a partner who already speaks CDISC, ICH, and GxP.
02
Audit readiness, data provenance, and compliance - engineered in from the first architecture decision.
Every platform we build is architected for environments where traceability, data integrity, and human governance are non-negotiable. We design for GxP, ICH E6(R3), 21 CFR Part 11, and FDA/EMA expectations from the first architecture diagram forward - so what your teams deploy holds up the first time it meets a regulatory reviewer, an auditor, or an internal quality function.
03
Systems that go live, hold up under real workloads, and scale with your operations.
Our measure of success is what's running in your environment six months after we deliver it. That standard shapes how we scope, how we architect, and how we hand over. Every engagement is built to move from first conversation to live system on a timeline and footprint that works for a regulated enterprise - with knowledge transfer, documentation, and operational readiness built into the path.
Whether you're evaluating Veractra for your CSR workflows, exploring Revectra as your DDF platform, scoping a Data or AI consulting engagement, or thinking through how intelligent automation can reshape your clinical operations - we're ready for the conversation.