ClinEvra

ClinEvra is an AI-powered Protocol Copilot developed by Inductive Quotient that transforms clinical protocol documents into structured, review-ready clinical assets and metadata. It is designed for clinical operations, data management, and regulatory teams seeking to reduce manual interpretation effort, improve consistency across studies, and support metadata reuse throughout the clinical data lifecycle.

The tool ingests protocol content from PDF, Word, and connected sources, then applies a governed workflow to extract clinical, statistical, and operational elements. Outputs include study details, schedules of assessments, trial domains, specifications, and protocol-driven downstream assets, all with review, approval, and traceability built into the process.

Core Features

• Protocol Ingestion: Accepts protocol content from PDF, Word, and connected systems.
• Automated Extraction: Derives key clinical, operational, and statistical elements through AI-powered extraction.
• Structured Asset Generation: Generates study details, schedules of assessments (SOA), trial domains, specifications, and metadata-driven outputs.
• Review and Approval: Supports governed review, comments, and approvals before outputs are used downstream.
• Validation Support: Enables protocol-driven validation and downstream-ready edit check logic.
• Metadata Reuse: Connects outputs to reusable metadata and MDR-aligned workflows.
• Traceability: Preserves source-to-output traceability across the clinical data lifecycle.

How ClinEvra Works

1. Upload Protocol: Clinical protocol documents are uploaded into the platform.
2. Automated Protocol Extraction: Key clinical, statistical, and operational elements are automatically extracted from the uploaded documents.
3. Metadata and Validation Generation: The platform generates Define.xml/DBS, SDTM domains, USDM-aligned templates, and protocol-driven validations.
4. Submission-Ready Outputs: Traceable, MDR-integrated SDTM outputs are delivered in JSON, XPT, and SAS7BDAT formats.

ClinEvra supports MDR-aligned workflows and produces outputs in standard submission formats including JSON, XPT, and SAS7BDAT. Its traceability and governed approval process are designed to support study startup acceleration and downstream regulatory submission requirements.