Trialynx™ isn’t just software—it’s a clinical research engine.

Built for Intelligence. Designed for Trust. Engineered for Scale.

Our innovative, patent-pending platform harnesses 500+ AI agents and assistants to build, structure, and align every part of your study—guided by human-in-the-loop oversight for precision, compliance, and clinical relevance. By combining automation with deep domain expertise, Trialynx turns months of manual work into hours of intelligent execution. Built with enterprise-grade security and aligned with ICH, NIH, and FDA standards, it’s a platform that scales with you, protects your data, and frees you to focus on the science.

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500+ AI Agents

Working in harmony

Enterprise Grade

Security & Compliance

Human-in-Loop

Intelligent Workflows

Security & Privacy by Design

Trialynx™ is built from the ground up to safeguard your data and earn your trust. From encryption to compliance, every layer of our platform is designed to meet the highest standards of research integrity and institutional expectations.

Enterprise-Grade
Security

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🔒 Encryption

In Transit: TLS 1.3 / HTTPS
At Rest: AES-256 encryption

🛡️ Security Testing

SOC 2 Type II, ISO/IEC 27001 Compliant
GDPR & CCPA Compliant, AWS Security Standards

🤖 AI API Security (via OpenAI)

TLS 1.2+ secure communication, Data not used for training
SOC 2 Type II certified infrastructure

📋 Regulatory & Compliance Standards

SOC 2 Type II, ISO/IEC 27001 Compliant
GDPR & CCPA Compliant, AWS Security Standards

⚡ DDoS Protection

Real-time threat mitigation with Cloudflare

👁️ Security with Flusk

Real-time leak detection and privacy rule audits
20+ automated security checks

Our Success Metrics

What we measure. What we’re improving.
What you can expect.

Upon customizing Trialynx to your team's workflows, documents, and review processes, we expect to deliver measurable gains in speed, accuracy, and efficiency. These are the success metrics we track and continuously optimize:

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Days

From Synopsis to Fully Built Study

Trialynx turns weeks of siloed effort into focused, collaborative sessions—transforming a synopsis into a complete study plan and first drafts of all documents.

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Near-Final First Drafts

Initial drafts require only minor edits—saving time and reducing downstream friction.

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Rounds

Fewer Revision Cycles

Enterprise alignment and built-in compliance reduce review cycles dramatically.

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Fewer IRB Resubmissions

Documents arrive aligned, consistent, and clear—reducing IRB clarification requests and delays.

Before Trialynx: Manual, Slow, & Fragmented

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Before Trialynx

Weeks 1-3: Draft protocol manually using templates and prior examples

Weeks 3-6: Iterate with multiple groups via long email threads

Weeks 6-10: Finalize and submit protocol for IRB review

Weeks 10-12: Receive IRB approval and begin building study plans, SOPs, consents, and site docs

Weeks 12-16: Re-engage stakeholders—realize protocol needs amendments based on new input

Weeks 16+: Write a protocol amendment, redo core documents, manage version chaos, and prep for resubmission

Total: 16+ weeks—just to draft, align, and finalize the base core documents (before the study even starts)

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With Trialynx

Day 1: Upload a short synopsis or existing protocol. Trialynx builds your core study framework.

Day 2-5: All key stakeholders collaborate in real time to refine the study details

Day 3: Instantly generate >90% complete first drafts of every required document—in perfect alignment.

Days 4-7: Team reviews, finalizes, and prepares documents for submission.

Week 2: Submit a complete, consistent, IRB-ready package.

Weeks 3+: Obtain IRB approval, empower sites with pre-populated documents, and prepare for first patient in.

⚡ From synopsis to site-ready—Trialynx turns weeks of chaos into streamlined clarity.

Protocol Digitization & Digitalization

From Static Documents to Dynamic Data Infrastructure

Digital protocols eliminate duplication, reduce human error, and unlock true scalability. With Trialynx™, your protocol becomes more than a document—it becomes the engine of your entire trial.

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Study Digitalization

Build your entire study from data—not documents.

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AI-assisted design from a simple protocol synopsis
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Instant document generation
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Structured data output ready for downstream use

This is how Trialynx takes you from synopsis to fully built clinical trial—in hours, not months.

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Protocol Digitization

Turn static protocols into structured, actionable data.

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Extract key elements like objectives and eligibility
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Convert text to structured data elements
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Prepare data for analysis and content reuse

This is how Trialynx transforms traditional protocols into smart, connected frameworks ready for what’s next.

Are you curious about the future of fully digital clinical trials? Book a call