Build a compliant,
submission-ready protocol, fast.
NVIDIA Inception Partner
Protocol development is slow, chaotic, and risky.
4+ months
Months lost to version chaos
Endless loops
Reviews back and forth
Hidden risks
Surface late as costly amendments
Blind spots burn budget and stall enrollment.
Sources: Tufts CSDD, Deloitte, PhRMA, McKinsey.
We understand the pressure of getting to first-patient-in without
sacrificing scientific rigor, so we built the Hub AI-native, not just AI-powered.We understand the pressure of getting to first-patient-in without sacrificing scientific rigor, so we built the Hub AI-native, not just AI-powered.
Legacy tools bolt AI on after the fact. Avenio builds intelligence into the protocol itself. The protocol thinks with you.
Trained on 25,000+ protocols
and 70B+ clinical parameters, across therapeutic areas
Deterministic, low-hallucination
Consistent, auditable outputs with human oversight
Compliant by design
ICH/FDA aligned; 21 CFR Part 11 audit trail; your data never trains our models
From concept to submission-ready in three steps.
Draft with AI
Align each section with built-in clinically trained AI guidance
Collaborate
Bring every stakeholder into one collaborative workspace
Surface risk
Risk Radar flags inconsistencies and risks with resolution paths
Start with a single protocol and see the difference within days.
Protocols that reach first-patient-in faster.
28%
Faster first-patient-in
40%
Fewer amendments
50%
Less authoring time
$120K+
Saved per protocol
Avoid the budget burn, blind spots, and downstream delays of manual protocol development.
One hub, every stakeholder.
Clinical Development
Faster, higher-quality protocols, fewer amendments
Medical Writers
Draft from intelligence, not a blank page
Regulatory
ICH/FDA alignment and 21 CFR Part 11 by design
Biostatistics
Consistent endpoints, criteria, and schedules
Each role gets value on day one.
The Intelligent Protocol Hub is AI-native by design.
AI bolted onto legacy protocol workflows
- AI requires a new skill, 'prompt engineering,' to draft
- AI after errors surface in review
- AI after costly amendments
- AI catches risk downstream
- AI waits for the process.
Avenio AI: intelligence built into the protocol
- Draft: AI aligns each section at design
- De-risk: risks & gaps caught as you write, at source
- Collaborate: real-time, version-controlled
- Comply: ICH/FDA misalignments surfaced proactively
- The protocol thinks with you.
28%faster first-patient-in
Secure and compliant by design.
Data isolation
Your data stays in your instance, never used to train models. Bring your own cloud (GCP or AWS).
21 CFR Part 11
Native audit trail, e-signatures, and version lineage built into the workflow.
SOC 2 & HIPAA
Certification in progress; architected for regulated environments from day one.
Teams are already winning with Avenio.
“A nerve center for clinical trial design... cuts weeks off the Concept to First-Patient-In timeline.”
Haytham E., CMO · G2, 5★
“Domain-specific intelligence... handles structured and unstructured data smoothly. Setup was very easy and straightforward.”
Nigel G., Clinical Operations Leader · G2, 5★