Clinials: AI Protocol Intelligence Platform for Clinical Trial Document Generation
Clinials is an AI powered protocol intelligence platform purpose built for the clinical trials ecosystem. From a single protocol upload, it generates the complete document suite a study needs to activate, cost, and recruit for, plus supporting tools such as protocol amendment comparison and operational protocol synopses for teams without a clinical background.
Why it matters Protocol data currently gets extracted and reorganised by hand, by sponsors, CROs, sites, and central labs alike, before proposals can be priced, sites can open, or patients can be recruited. That manual step is slow, repetitive, and introduces transcription risk that compounds with every protocol version and amendment. Removing it accelerates trial activation and reduces cost across the whole ecosystem, and it does so without replacing the commercial or clinical judgement of the team using it.
How it works A protocol is uploaded and processed in two to four minutes. Clinials generates structured, citation linked outputs including the Lab Listings Report (all protocol required analytes, grouped by category such as PK, immunogenicity, safety labs, genomics, and biomarker analysis), Schedule of Activities, and Lab Tests by Timepoint report, alongside plain language and operational summaries, multilingual and diversity inclusive patient facing materials, recruitment and prescreening tools, and informed consent templates. Every output is produced in draft, fully editable, and traceable to its source protocol section. Clinials extracts what the protocol requires, it does not assume panel combinations or pricing, that commercial decision stays with your team. The platform is browser based, with no API or IT project required to trial.
Who it is for Sponsors, CROs, sites, IROs, SMOs, and central laboratories or specialist diagnostic providers who currently spend analyst or clinical time manually extracting and reorganising protocol data before proposal, activation, or recruitment work can begin.
Proof to date Documented efficiency gains of up to 70 percent in document turnaround, and 2.5 hours saved per protocol at typical volumes (Clinials value case analysis; Tufts CSDD 2024; Florence Healthcare 2024). Life Sciences Queensland Awards finalist. Active customers across sites, sponsors, CROs, IROs, and SMOs. AWS hosted infrastructure holding SOC 2, ISO 27001, and FedRAMP authorisation; AES 256 encryption at rest and in transit; a GxP compatible, exportable audit trail with full protocol citation. Customer data is never used to train or develop Clinials' AI.
Next steps Start with a free trial, then setup single tenanted account on Clinials.com: run several representative protocols through the platform and compare against your current manual process on time, accuracy, and document quality.
About Clinials
Clinials is an AI-powered platform designed to streamline clinical trial operations by automating the generation of clinical trial documentation. The platform utilizes agentic AI to ingest protocols, investigator brochures, and other source documents to create review-ready content, including plain-language synopses, patient information sheets, operational summaries, and recruitment materials. By transforming dense trial protocols into structured, traceable, and multilingual outputs, the company aims to reduce manual administrative burdens, improve consistency across global trial operations, and ensure that content remains secure and compliant with regulatory requirements. The system is built for sponsors, clinical research organizations (CROs), and trial sites, allowing for human-in-the-loop editing, version control, and seamless export into various formats.
For clinical research stakeholders, Clinials solves the challenge of translating complex trial data into actionable, patient-friendly communication, which is critical for study feasibility, regulatory review, and participant engagement. By automating content workflows, the platform helps clinical trial teams accelerate startup timelines and improve collaboration across cross-functional departments. The company focuses on the specific niche of trial material communication and operational documentation, distinguishing its purpose-built AI from broader, generic tools. Founded in 2021, the company is recognized for its role in enhancing trial transparency and accessibility, providing solutions that assist in managing trial schedules and stakeholder interaction throughout the entire research lifecycle.
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