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Company description

Clinials is an AI platform that converts clinical trial protocols and supporting documents into structured, review-ready documentation for use across feasibility, study operations, regulatory review, and patient communication. Founded in 2021, the platform serves sponsors, CROs, clinical trial sites, consultants, labs, and regulatory teams, generating role-specific outputs with full traceability back to source data. Clinials operates in a fully closed environment, meaning uploaded data is not shared with external large language models, not used for model training, and not exposed to third parties.

The platform focuses specifically on clinical trial content generation and communication — an area it distinguishes from competitors that concentrate on drug discovery, prediction, or data matching. Clinials describes itself as the first to develop AI-powered plain language protocol synopses tailored to clinical trial industry standards, and claims to accelerate clinical trial processes by up to 149%, reduce protocol review time by up to 70%, and accelerate approvals by up to 40%.

Core Document Outputs

• Schedule of Activities: A complete visit-by-visit breakdown derived from the protocol, covering biomarkers, procedures, and endpoints to support study execution planning and budget development.
• Operational Protocol Synopsis: A structured summary of study design, objectives, endpoints, procedures, and operational requirements intended for study teams.
• Budget Discovery: A protocol-derived breakdown of study activities, assessments, biomarkers, and endpoints to support feasibility analysis and early-stage budget planning.
• Plain Language Protocol Synopses: Simplified summaries of protocol content designed for internal teams, sites, regulators, and investors.
• Operational and Feasibility Summaries: Structured outputs supporting planning and execution across the trial lifecycle.
• Compliance-Ready Reports: Documentation formatted to support regulatory review and audit requirements.
• Patient-Facing Materials: Plain-language and multilingual summaries, patient information sheets, prescreening content, and landing pages derived from protocol content.

Compliance and Data Security

• Encryption and privacy: All clinical trial documents and source files are encrypted and remain within the user's organisation.
• Regulatory compliance: The platform is designed to support GDPR, HIPAA, and regulated clinical trial workflows.
• Role-based access control: Permissions are configurable for sites, CROs, sponsors, and partners.
• Versioning and traceability: Document versions are tracked and linked back to protocol source data to support audit readiness.
• Closed environment: No data is shared with external large language models, and no training occurs on user content.

Workflow and How It Works

• Users upload a clinical trial protocol along with supporting documents such as a Schedule of Activities or Investigator Brochure.
• Clinials extracts and structures the relevant content, generating role-specific documents in minutes.
• Outputs are designed to be review-ready, traceable to source documentation, and suitable for cross-functional collaboration across sites, CROs, sponsors, and regulatory teams.
• The platform supports the full trial lifecycle from planning and feasibility through to execution and patient communication.

Users and Stakeholders Served

• Contract Research Organisations (CROs)
• Clinical trial sites and site networks
• Sponsors and biotech companies
• Regulatory teams
• Labs
• Consultants and advisors to the medical research industry
• Patients (via plain-language and multilingual materials)

Recognition and Background

• Named among the Top 50 Women-Led Companies disrupting Healthtech.
• Featured in Top 10 AI Trends in Healthcare lists for both 2023 and 2025.
• Finalist at the Life Sciences Queensland 2024 Awards.
• Placed second in the RESI Boston Innovator's Pitch Challenge.
• Founded in 2021 in response to growing documentation complexity in clinical research.

Clinials is available on a free trial basis with no credit card required, and is positioned for use by clinical trial teams worldwide across sites, CROs, sponsors, and labs.

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Software attributed to Clinials

• Clinials Protocol Intelligence PlatformView

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