eProtocol

Clinion eProtocol is an AI-assisted clinical trial protocol generation platform designed for medical writing teams. It automates the drafting, review, and finalization of clinical trial protocols, producing guideline-compliant documents in significantly less time than traditional manual methods. The platform targets sponsors, contract research organizations, and medical writing groups that need to reduce protocol development timelines while maintaining regulatory compliance and audit-ready traceability.

According to Clinion, eProtocol can generate up to 90% of a fully finished clinical protocol in hours, reduce resource and timeline costs by up to 60%, and ensure alignment with ICH M11, TransCelerate, and sponsor-specific templates from the outset.

Core Capabilities

• AI-driven protocol draft generation based on uploaded protocol summaries and reference documents
• Structured drafts aligned with ICH M11 and TransCelerate guidelines, drawing on sample client protocols, a trained knowledge base, and trusted third-party sources
• Real-time collaboration tools allowing medical writers and reviewers to edit, comment, and track versions within the platform
• Full version tracking and audit-ready traceability throughout the drafting and review process
• Export of finalized protocols as Word documents
• Role-based access supporting Admin, Medical Writer, and Reviewer workflows

Four-Step Protocol Workflow

1. Upload Your Summary: Users provide a brief protocol summary along with reference documents; the AI analyzes the input and extracts key details.
2. Generate a Compliant Protocol: The AI produces a structured clinical trial protocol draft aligned with TransCelerate and ICH guidelines.
3. Collaborate in Real Time: Medical writers and reviewers edit and comment on the draft with full version tracking active throughout.
4. Finalize and Export: Reviewers confirm completeness and export the protocol as a Word document.

AI Reliability and Bias Mitigation

• The AI is trained on clinical trial protocols spanning multiple therapeutic areas, geographies, and trial phases
• Outputs are generated from a curated, regulated knowledge base intended to produce balanced, evidence-based drafts
• The system is designed to follow industry standards rather than commercial or personal bias
• Medical writers retain control to review, refine, and adjust AI-generated content before finalization

Responsible AI Principles

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

Clinion eProtocol integrates with Clinion's broader suite of clinical trial solutions, including EDC, RTSM, eSource, eConsent, CTMS, CSR Automation, eTMF, and ePRO. The platform is described as compliant with global regulatory standards and built around data privacy and security practices consistent with Clinion's Responsible AI commitments.