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Your Journey to AI Accelerated Clinical Research Begins Here

Logo BUILT FOR INNOVATION-DRIVEN ENTERPRISES

Radically Simplify Your Clinical Trial Development & Documentation

Trialynx empowers teams to align decisions, data, and documents—delivering faster trials, better outcomes, and enhanced compliance.

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Consent
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Protocol
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Schedule
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Brochure
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Study Plan
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Your team. Your templates.
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Strategic AI, Automation, Human Oversight

How Trialynx Powers Smarter Trials

AI moves fast, automation provides precision, and human-in-the-loop workflows inspires confidence.

AI-powered trial setup

One Platform. Every Document. Perfectly Aligned.

Instantly generate all your trial documents in perfect alignment without duplication or rework. Use our compliant templates or bring your own for full customization.

One Platform Mobile

Core Documents

tech-bullet Protocol
Consent
Investigator Brochure

Schedule of Activities

tech-bullet Schedule of Activities
Participant Budget
Participant Burden
Site Burden
Billing Plan

Study Plans

tech-bullet Statistical Analysis Plan
Data & Safety Monitoring Plan
Clinical Monitoring Plan
Project & Risk Management Plan
Quality Management Plan

Site Forms (25+)

tech-bullet Reports
Logs
CRFs

Study Reports

tech-bullet Clinical Study Reports
Interim Reports
Annual Reports

Operational

tech-bullet Legal Documents
SOPs
Policies

Flexible Support, One Powerful Platform

Partner With Our Experts or Supercharge Your Team

Tech-Enabled Services

Your research partner, powered by Experts + Tech

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We handle discovery, study building, and document delivery

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We bring in the experts—so you don't need to build a large internal team

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We eliminate the worry—so research feels simple and exciting, as it should be.

Trialynx Technology

Streamline your workflow

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Accelerate study development—your way, with your team

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Collaborate in real time—keep everyone aligned

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Maintain 100% control—ensure consistency and clarity across all functions

Our Success Metrics

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

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

5 Days

From Synopsis to First Drafts

Real-time collaboration eliminates weeks of rework—delivering aligned documents faster.

90% Complete

Near-Final First Drafts

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

2 Rounds

Fewer Revision Cycles

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

50%

Fewer IRB Resubmissions

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

Eliminate Chaos. Build with Confidence.

Turn messy documents into streamlined workflows

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Before Trialynx

Inefficient, Outdated, and Disconnected

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

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

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

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Weeks 10-12: Respond to IRB requests, hopefully receive IRB approval, and begin writing other documents

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

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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 core documents (before the study even starts)

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With Trialynx

Modern Workflows. Aligned Teams

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

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

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Day 5: Instantly generate near-final (>90% complete) first drafts all your documents—in perfect alignment

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Days 6-7: Team reviews, finalizes, and prepares documents for submission

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Week 2: Submit a complete, consistent, IRB document set to the IRB.

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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.

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Medical team collaborating

Intelligent Clinical Trials Start Here

Trialynx turns hours of manual effort into a guided, seamless experience—so your team can focus on great science, not busywork.

Welcome to Trialynx™

Study Builder, Reinvented

Imagine A World Where Your Study Is Built In Full Alignment, From Day 1

No more fragmented siloes. No more data trapped in documents. No more email chains or version confusion. Trialynx delivers a seamless, collaborative experience—so your team can work in sync from the start.

Build your study in hours—not months. With 500+ AI agents and built-in compliance guardrails, Trialynx transforms your synopsis into a robust trial framework. Collaborate in real time, approve with confidence, and move forward faster.

500+ Specialized Al Assistants & Agents
ICH, FDA, and NIH Compliance Compliance Guardrails
Real-time collaboration for fast alignment, clear visibility, and confident decisions

Trialynx Is Built For Trailblazing Enterprises

Custom-Built For Precision, Designed To Scale

Trialynx embeds your institution's templates, workflows, and formatting directly into the platform so your team stops guessing and starts executing. No more hunting for the right template. No more formatting errors. Just aligned, compliant documents every time.

What Sets It Apart:

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Templates built once, reused by all

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Locked formatting for brand and regulatory consistency

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Institution-specific workflows and roles

Custom Built Design

Testimonial

What Our Customers Are Saying

★★★★★
"It's with mixed feelings that I found Trialynx. It makes building studies and writing documents effortless. I wish I'd had it earlier; it would've saved me countless hours."
GM
Gerald Minuk, MD
Associate Professor and Clinical Researcher
★★★★★
"Working with Trialynx is a game changer. We completed 40 fully customized protocols—each turned around in just 48 hours—enabling us to launch all of our trials weeks ahead of schedule."
RM
Ramesh Meesala
CEO Cliniv

Security

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.

Security Central Ring
Enterprise-
Grade Security
1

Encryption

In Transit: TLS 1.3 / HTTPS At Rest: AES-256 encryption
2

Regulatory & Compliance Standards

SOC2 Type II (In Progress) ISO/IEC 27001 (In Progress) GDPR & CCPA Compliant AWS Security Standards
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Security Testing

Real-time vulnerability scanning
Penetration Testing
Data leak detection & prevention
Auth protocol validation
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DDoS Protection

Real-time threat mitigation with Cloudflare
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AI API Security

TLS 1.2+ secure communication Data not used for training No documents are shared with AI providers
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Security with Flusk

Proactive scanning GDPR compliance ready Real-time threat detection Enterprise-grade security

FAQ’s

Frequently Asked Questions

Bring Clarity, Speed, and Structure to Your Trials

Expert services + powerful technology = smarter research.

Whether you need a turnkey trial development service or want to empower your internal teams with intelligent tools, Trialynx meets you where you are.

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Trialynx lynx graphic - representing agility and precision in clinical trials
Trialynx lynx graphic - representing agility and precision in clinical trials