Platform
Trialynx combines decades of clinical research expertise, public evidence from ClinicalTrials.gov and PubMed, and 500+ AI agents, assistants and automations. Your team designs, documents and launches trials from one structured source, with experts in command at every step.
How it works
Every trial balances science, operations, documentation and data. Trialynx holds all four in the same structured study, so a change in one is reflected in the rest.
01Scientific design
Trialynx draws on ClinicalTrials.gov and PubMed to summarize evidence, surface relevant references and track decisions throughout study development, so every design choice is data-driven, transparent and review-ready.
02Operational feasibility
Feasibility can make or break a trial. Trialynx surfaces site and patient challenges early and brings key stakeholders into study development, before they turn into amendments and delays.
03Document generation
Generate 90% complete first drafts of your study documents directly from your study design, in your own templates, so your experts spend their time refining instead of rewriting.
04Digital data flow
Every study element is captured as structured, reusable data, so it moves across documents and systems without re-keying. Cleaner inputs simplify EDC and CTMS setup and keep one source of truth as the study evolves.
From static documents to dynamic data
Digital protocols eliminate duplication, reduce human error and unlock real scale. Start from a synopsis, or bring the protocol you already have.
“The industry and the FDA are moving toward real-time clinical trials, and you cannot run a real-time trial on paper.”
Trialynx aligns with the CDISC USDM and ICH M11 protocol standards, the digital foundation for the real-time trials the FDA is now piloting.
What it generates
Use our compliant templates or bring your own. Every document draws on the same study design, so they agree from the first draft.
Security & compliance
Built for the people who answer to auditors, IRBs and regulators. Every layer, from encryption to oversight, protects your data and keeps your team in control.
Questions
An AI-powered platform for designing and documenting clinical studies. Your team builds the study once, as structured data, and Trialynx generates the aligned document package: protocol, consent, SAP, budgets, site forms and more.
Your institutional and sponsor templates are built into the platform. Researchers answer guided questions and Trialynx generates complete, aligned documents, without version-control headaches, copy-paste errors or document drift.
Most tools help draft one document at a time. Trialynx is a collaborative workspace for the whole study package. Sponsors, CROs, writers, statisticians and subject-matter experts work side by side in real time, and every document stays synchronized with the study design.
Protocols, informed consent forms, investigator brochures, statistical analysis plans, monitoring and data management plans, budgets, site forms and more. The document engine is built around ICH, NIH and GCP standards and your own site and sponsor templates.
Your data is never used to train AI models. It is processed and stored in secure, dedicated environments, encrypted in transit (TLS 1.2 or higher) and at rest (AES-256), and enterprise-, study- and role-based permissions control who can access it.
No. Trialynx is built for researchers, clinical teams and medical writers, not programmers. A step-by-step interface guides you through targeted questions and generates the documents for you.
Book a 30-minute call and see your study take shape, from synopsis to an aligned document package.