clinion

eProtocol Automation

Fully Finished, Compliant Protocols in an Hour

AI-Powered. Collaborative. Compliant.

Clinion's eProtocol automation software interface, showing an AI-powered tool for generating compliant clinical trial protocols.

Results

Transform Clinical Trials Protocol Creation with Measurable Results

Clinion’s eProtocol Generation transforms how medical writing teams work, enabling them to produce a complete clinical trials protocol with greater speed and guaranteed compliance—all while reducing costs, simplifying collaboration, and maintaining perfect, audit-ready traceability.

Faster Protocol Development

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Generate up to 90% of your fully-finished clinical protocol design in hours, reducing weeks of manual effort.

Regulatory Compliance

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Ensure your clinical trials protocol is compliant with ICH M11, TransCelerate, and sponsor-specific templates from the start.

Cost and Time Savings

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Save up to 60% on resources and timelines with automated AI generation.

Clinion eProtocol – AI-Powered Protocol Automation in Four Simple Steps

Streamline Your Clinical Trials Protocol Workflow in Four Steps

1

Upload Your Summary

Provide a brief protocol summary along with reference documents. AI analyzes the input, extracting key details.

2

Generate a Compliant Protocol

AI creates a structured clinical trials protocol draft aligned with TransCelerate and ICH guidelines, using sample client protocols, a trained knowledge base, and trusted third-party sources.

3

Collaborate in Real Time

Medical writers and reviewers edit and comment on the eProtocol draft with full version tracking.

4

Finalize and Export

Reviewers finalize the clinical trials protocol, ensuring completeness, then export it as a Word document.

Why Clinion?

Why Choose Clinion eProtocol for Your Clinical Trials?

Purpose-built for medical writing teams, Clinion eProtocol combines cutting-edge AI with regulatory compliance to transform your clinical protocol design and development process.

Pioneering AI Automation

Accelerate your trials with AI-driven protocol drafting and clinical trial protocol optimisation that’s faster than traditional methods.

Designed for Medical Writing Teams

Streamline end-to-end clinical trials protocol development with a specialized solution for efficient, compliant, error-free drafting.

Secured and Compliant by Design

Ensure secure, transparent, and compliant clinical trials protocol with ethical AI practices tailored for clinical trials.

Interactive Demo

Explore eProtocol

Guided Walkthroughs for the eProtocol Product

eProtocol Guided Walkthroughs

Take a guided tour through our end-to-end workflow from each key perspective. See how Admins effortlessly set up projects and manage users, while a Medical Writer uses AI to instantly generate a structured protocol draft. Then, step into the Reviewer’s role to add inline comments, track revisions, and approve content, creating a seamless collaborative cycle that produces a compliant, submission-ready protocol faster than ever.

Solutions

Our Integrated Suite of Solutions

Extend your clinical trial capabilities by integrating Clinion eProtocol with our comprehensive suite of specialized solutions, seamlessly enhancing every study dimension.

FAQS

Frequently Asked Questions

Discover quick solutions to your Clinion eProtocol platform queries

Designing a clinical trial protocol starts with defining the study objective and choosing the right trial phase and population. Next, inclusion/exclusion criteria, treatment arms, randomization, and endpoints are set. The protocol must detail visit schedules, safety monitoring, and data collection plans. It’s finalized after input from medical, regulatory, and biostatistics teams to ensure compliance and feasibility.

A clinical trial protocol is a regulatory document that outlines how the trial will be conducted, including objectives, methodology, and safety procedures. A study plan, often used internally, may include operational or logistical details not required for regulatory submission. While both guide trial execution, the protocol is legally binding and subject to regulatory review.

Clinion eProtocol uses AI to generate ICH M11 and TransCelerate-compliant drafts in minutes. It automates up to 90% of the writing process - drafting, review, collaboration, and finalization, on a single platform. This reduces costs by up to 60%, improves consistency, and ensures regulatory compliance.

Yes, the workflow is designed to keep medical writers in control. After the AI generates the initial draft, writers can review, refine, and adjust the content as needed. This ensures the final document reflects both the study’s intent and the team’s preferences, while maintaining speed and structural integrity.

Clinion’s AI is trained on a diverse set of real-world clinical trial protocols from multiple therapeutic areas, geographies, and trial phases. It uses a curated, regulated knowledge base to ensure balanced, evidence-based outputs. The system is designed to follow industry standards, not personal or commercial bias, making it a reliable, objective support tool for protocol drafting.

Still have questions?

Explore how Clinion AI can accelerate your trial – reach out to our team.


Responsible AI

Clinion follows Responsible AI principles, ensuring its AI tools are built for safety and reliability,
and remains committed to Data Privacy and Security at every step.

Unlock the Future of Clinical Trials with Clinion.

Cut your trial costs by 35% and accelerate your time-to-market by 30%

Compliance

Fully Compliant with Global Standards

FDA,HIPAA and ISO Logos
ich ,gdpr ,eu compliant logos
Clinion’s adherence to global regulatory standards including FDA 21 CFR Part 11, HIPAA, ISO 9001:2015, ISO 27001:2013, ICH, GDPR, and EU Annex 11.