Clinion eProtocol

Clinion eProtocol is a protocol authoring platform designed to support the drafting, review, and management of clinical trial protocols. The platform uses study summaries, reference documents, protocol templates, and structured knowledge sources to generate protocol drafts aligned with industry standards and organizational requirements within hours. By combining AI-assisted content generation with collaborative review workflows, Clinion eProtocol helps medical writing teams standardize protocol development, reduce manual authoring effort, and maintain traceability throughout the document lifecycle.

Key Capabilities

AI-Assisted Protocol Generation

Uses Generative AI to analyze study summaries and supporting documents and generate structured clinical trial protocol drafts. The platform can generate up to 90% of protocol content based on available inputs and predefined templates.

Regulatory-Aligned Templates

Supports protocol generation using ICH M11, TransCelerate, and organization-specific templates to help standardize protocol structure and content across studies.

Reference Document Utilization

Incorporates information from study summaries, prior protocols, reference materials, and organizational knowledge sources to support protocol development.

Collaborative Authoring and Review

Enables medical writers, clinical teams, and reviewers to collaborate within a shared environment using comments, content revisions, and review workflows.

Version Control and Audit Trails

Maintains document histories, revision tracking, and audit trails, providing visibility into changes throughout the protocol development process.

Template and Knowledge Management

Allows organizations to maintain standardized templates, reference content, and approved knowledge sources to support consistency across protocol development programs.

Document Export and Finalization

Supports protocol review, approval, and export into commonly used document formats for downstream regulatory and operational use.

Key Benefits

• Up to 80% of protocol content can be generated automatically from study inputs and reference materials

• Up to 60% reduction in protocol development time and resource requirements

• Standardized protocol structure through ICH M11, TransCelerate, and organization-specific templates

• Centralized collaboration for medical writers and reviewers

• Complete version history and revision tracking

• Improved consistency across protocol documents

• Streamlined review and approval workflows

• Support for regulatory and organizational protocol standards

Clinion eProtocol is designed for pharmaceutical companies, biotechnology organizations, CROs, medical writers, clinical development teams, and regulatory stakeholders seeking to standardize protocol authoring, reduce manual drafting effort, and manage protocol development through AI-assisted workflows.