Domain-Native. Production-Grade. Regulatory-Aware.
Statsby Solutions partners with pharma, biotech, and clinical research organizations to turn ambitious AI and data strategies into production systems - across the enterprise. From research and development through clinical operations, regulatory, medical affairs, pharmacovigilance, and commercial - we bring deep domain expertise and hands-on engineering to every engagement.
We offer a connected set of capabilities that span the full AI and data value chain - from modern data platforms and generative AI to agentic automation and the MLOps discipline that keeps everything running. Each capability is valuable on its own. Together, they give pharma and clinical teams a single, trusted partner for the entire journey from idea to production.
Every engagement begins with alignment on your business goals, data readiness, and regulatory context - and continues with you through deployment, adoption, and scale.
High-performing AI begins with high-quality, well-governed, accessible data. We design and engineer modern cloud-native data platforms purpose-built for pharma and clinical workloads - unifying clinical, operational, regulatory, real-world, and commercial data into governed, AI-ready foundations your teams can build on with confidence.
We design and deploy production-grade Generative AI systems that your medical, regulatory, clinical, commercial, and safety teams can confidently put to work - because every output is source-grounded, verifiable, and built to the evidentiary standards pharma demands. Our work spans the enterprise: from regulatory writing and medical affairs to pharmacovigilance, quality, and commercial.
We design and deploy multi-agent systems that reason across data sources, orchestrate complex multi-step workflows, and act under human governance - freeing your teams to focus on the judgment and science that matters. Every agentic system we build includes human oversight at key decision points, full audit trails, and transparent reasoning so your quality and compliance teams stay firmly in control.
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.
We follow a disciplined, phase-based methodology designed for regulated environments - where speed and quality must coexist, and every system must be ready to stand up to audit from day one.
We begin with your business objectives, your data landscape, and your regulatory context. Together, we run an AI readiness assessment, prioritize high-value use cases, evaluate data quality and availability, and shape a build-vs-buy strategy. The outcome is a sequenced, scoped plan your technical, business, and compliance stakeholders are fully aligned on before a single line of code is written.
Production-grade architecture from day one. Every system is designed for GxP compliance, audit readiness, and enterprise scale - with data models, integration patterns, security architecture, and governance frameworks engineered in, not bolted on. The result is an architecture that meets regulatory expectations and business timelines in equal measure.
Engineering execution with continuous validation. We build in your environment, on your cloud, and integrate with your existing systems. Deployment includes monitoring, observability, and governed model-serving infrastructure aligned with FDA and EMA guidance - so your teams go live with confidence and your compliance colleagues stay comfortable throughout.
We build your team's capability alongside the system. Knowledge transfer, thorough documentation, and enablement are built into every engagement, so your people fully own what we deliver. For organizations that want ongoing partnership, we offer managed operations as an optional extension - on your terms, renewable annually.
We are platform-informed, never platform-locked. Our engineers work across the ecosystems pharma and clinical research organizations have standardized on - and we recommend based on what's right for your use case, architecture, and existing investments.
Regulatory & Clinical Domain Expertise
Cloud Platforms
Data Platforms & Engineering
AI / ML & Generative AI
MLOps & Infrastructure
Orchestration & Integration
Whether you're modernizing your clinical data foundation, deploying Generative AI into regulated workflows, pioneering agentic automation across your operations, or taking your AI systems to production-grade maturity - we'd love to start the conversation.