CSR Automation

Clinion CSR Automation is an AI-enabled tool designed to help medical writers and clinical teams generate Clinical Study Reports (CSRs) that are structured, consistent, and aligned with ICH E3 guidelines. The tool extracts content from study documents — including Protocols, Statistical Analysis Plans (SAPs), and Tables, Listings, and Figures (TLFs) — and uses Generative AI to auto-populate CSR sections, reducing the time and manual effort typically required for report authoring and compilation.

The platform targets clinical operations teams, medical writers, and regulatory affairs professionals involved in preparing CSRs for regulatory submissions such as New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs). According to Clinion, the tool can auto-populate approximately 70% of a CSR and reduce submission timelines by up to 70% compared to traditional manual methods.

Core Workflow

1. Upload Study Documents: The AI scans uploaded Protocol, SAP, and TLF files to extract relevant study content.
2. AI Populates CSR Sections: The system automatically fills structured CSR sections using intelligent mapping, linking source document content to the corresponding report sections without manual tagging.
3. Human Review and Refinement: Medical writers review the AI-generated content, add comments, and refine or regenerate individual sections as needed. Full editing flexibility is retained throughout this stage.
4. Submission-Ready CSR: The finalized report is formatted and structured for regulatory submission.

Key Features

• AI-Generated CSRs: Generative AI extracts content from Protocol, SAP, and TLFs to produce structured CSR sections, reducing manual writing time and supporting consistency across the document.
• Lifecycle and Version Control: Manages the full CSR lifecycle from initial draft to final approval, with status indicators for each section, a complete revision history, version comparison, and access to previously generated documents for audit purposes.
• Dynamic and Custom Templates: Includes a built-in ICH E3-compliant template and supports upload of custom templates. Client Admins can manage a library of templates to maintain formatting standards across studies.
• Collaboration Tools: Supports inline commenting on specific text, section reversion with feedback, and content approval within a single platform, enabling iterative review cycles between authors and reviewers.
• Compliance Assurance: Built-in compliance checks are applied against ICH E3 guidelines and global regulatory standards. Admins can manage standardized templates to ensure every report meets submission requirements.
• Intelligent Mapping: The AI links content from source study documents to the appropriate CSR sections automatically, with support for manual overrides when study-specific adjustments are needed.

Responsible AI Principles

• Accountability
• Transparency
• Privacy and Security
• Reliability and Safety
• Fairness

Clinion CSR Automation is part of a broader integrated suite that includes EDC, RTSM, eProtocol, eSource, eConsent, CTMS, ePRO, and eTMF solutions. The platform is built with data privacy and security considerations at each stage, in line with Clinion's stated Responsible AI commitments.