Clinials Protocol Intelligence Platform

Clinials Protocol Intelligence Platform is a document generation tool for clinical trials that reads uploaded protocols and supporting documents to produce structured, role-specific outputs. It is designed for sites, CROs, sponsors, and labs involved in regulated clinical workflows, covering use cases across feasibility, study operations, regulatory review, and patient communication. Documents are generated with full traceability to source data and are intended to be audit-ready.

The platform generates a range of clinical trial materials in minutes, including operational and patient-facing plain-language documents, multilingual summaries, schedule of activities, lab listings, source documents, patient information sheets, landing pages, and prescreening materials.

Document Types Generated

• Schedule of Activities: A complete visit-by-visit breakdown derived from the protocol, including 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 budget planning.
• Patient Information Sheets: Plain-language, patient-facing documents generated from protocol content.
• Feasibility Reports: Documents supporting site and sponsor feasibility assessments.

Compliance and Data Security Features

• Encrypted and Private: 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.
• Controlled Access: Role-based permissions are available for sites, CROs, sponsors, and partners.
• Versioning and Traceability: Document versions are tracked, and clear links back to protocol source data are maintained throughout.

Workflow Steps

1. Upload Protocol: Users upload the clinical trial protocol and any supporting documents, such as a Schedule of Activities or Investigator Brochure. Clinials ingests and structures the protocol content securely.
2. Create Content: Users select the document types they require, ranging from patient information sheets and operational summaries to budget discovery and feasibility reports.
3. Communicate the Trial: Users manage generated content through editing and previewing, version control, and export in PDF, DOCX, and CSV formats. All outputs are grounded in the source documents and are traceable and ready for review and collaboration.

Clinials is used by clinical trial teams across sites, CROs, sponsors, and labs worldwide. The platform supports cross-functional collaboration and is structured to serve different stakeholder roles, with role-based access controls reflecting the distinct needs of each group.