Now accepting early access partners

From protocol to publication

The integrated platform that automates clinical trial management and precision medicine workflows — with regulatory compliance built into every step.

Built for biotech · CROs · Research Institutions

The Problem

Researchers spend more time on administration than science

Clinical trials drown in fragmented tools, manual compliance checks, and disconnected workflows. The result: delayed treatments, inflated costs, and exhausted teams.

73%
of trial delays

stem from administrative burden, not scientific complexity

12+
disconnected tools

used by the average clinical research organization

40%
of compliance effort

spent on manual documentation and audit preparation

The Platform

One platform, every stage

Trialix covers the full clinical trial lifecycle in a single integrated environment. No more data silos, no more tool-switching, no more compliance gaps.

01

Protocol Design

AI-assisted protocol authoring with built-in templates from ICH, FDA, and EMA guidelines. Version-controlled, audit-ready from day one.

02

Data Collection & EDC

Unified electronic data capture across sites, devices, and modalities. Real-time validation catches errors at the source, not months later.

03

Analysis & Insights

Integrated biostatistics engine with automated interim analyses, adaptive trial support, and precision medicine cohort identification.

04

Regulatory Compliance

Continuous compliance monitoring across 21 CFR Part 11, GCP, GDPR, and HIPAA. Automated audit trails and submission-ready documentation.

05

Publication & Reporting

From statistical output to manuscript-ready figures and CONSORT-compliant reports. Accelerate the path from results to peer-reviewed publication.

Regulatory Compliance

Compliance as infrastructure, not afterthought

Regulatory requirements should be invisible guardrails, not roadblocks. Trialix embeds compliance into every workflow so your team never has to choose between speed and rigor.

21 CFR Part 11Electronic records & signatures
ICH-GCP E6(R2)Good Clinical Practice
GDPR / HIPAAData privacy & protection
CDISC / SDTMStandardized data submission
Auto-audit trail
Real-time monitoring
Submission-ready

Built For You

Purpose-built for life sciences

B

Biotech Companies

Accelerate your pipeline from IND to NDA with integrated trial management that scales with your portfolio.

C

Contract Research Orgs

Serve more sponsors with less overhead. Standardize workflows across trials while maintaining per-sponsor compliance.

R

Research Institutions

Empower investigators with a platform that handles the administrative burden so they can focus on the science.

Pilot Program

One price. Everything included.

Start with a 90-day guided pilot. No long-term contracts. Prove the value before you scale.

EARLY ADOPTER PRICING

Trialix Pilot Program

90-day guided engagement with full platform access

$4,900

one-time pilot fee

Full platform access for up to 10 users
Up to 2 active clinical studies
Regulatory compliance engine (FDA & EMA)
Protocol design & version control
Data collection and analytics pipeline
Dedicated onboarding specialist
Weekly check-in calls for 90 days
Custom integration support (API access)
Priority email & Slack support
Start Pilot Program

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Looking for enterprise pricing or a multi-study deployment? Let's talk

Early Access

Shape the future of clinical trials

We're partnering with a select group of forward-thinking organizations to refine the platform before general availability. Request access to join the program.

No spam. No commitment. Just early access to something that matters.