Now accepting early access applications · Miami, FL

Clinical
intelligence,
reimagined.

The intelligent trial management platform built for small and mid-size research sites. eTMF compliance, patient enrollment, real-time assessments — at a fraction of enterprise cost.

Request Early Access → See the Platform
10×
Cheaper than Medidata
$299
Starting per month
21CFR
Part 11 Compliant
<48h
Onboarding time
Atopic Dermatitis
Plaque Psoriasis
Hidradenitis Suppurativa
Alopecia Areata
Oncology
CNS & Psychiatry
Endocrinology
Cardiology
Rheumatology
Atopic Dermatitis
Plaque Psoriasis
Hidradenitis Suppurativa
Alopecia Areata
Oncology
CNS & Psychiatry
Endocrinology
Cardiology
Rheumatology
The Problem
Enterprise tools built
for enterprise budgets.
Small research sites are stuck between $100K/yr platforms they can't afford and Excel spreadsheets that fail FDA audits.
💸
Medidata Rave
Enterprise pricing designed for pharma companies running 500 trials. Overkill and unaffordable for a 3-trial derm site.
$50,000–$200,000 / yr
📊
Excel & Paper Binders
No audit trail. No version control. One FDA inspection and your site gets shut down. This is how most new sites operate.
Inspection failure risk
🏗️
REDCap / DIY
Free but requires an IT team to configure, maintain, and validate. No sponsor portal. No eTMF. Not built for clinical operations.
Months of setup time
The Solution
One platform.
Everything your site needs.
ClinovaIQ is audit-ready out of the box. From the first patient screen to final data lock — all in one place.
01
eTMF Document Management
TMF Reference Model compliant. Documents are immutable once finalized — only supersede, never delete. Sponsor remote monitoring access built in.
02
Patient Enrollment & Visit Tracking
Screen, enroll, and track every patient visit. Protocol deviation logging, consent management, and visit window alerts — all automated.
03
Clinical Assessment Engine
PASI, EASI, IGA, HAMD, RECIST — any assessment rendered from JSON config. Live scoring updates as your CRC fills in each field.
04
21 CFR Part 11 Audit Trail
Every action logged. Immutable. Who changed what, when, from where. E-signatures with re-authentication. FDA inspection ready from day one.
05
CIQ Intelligence Score
Your site's real-time compliance score out of 100. Sponsors see it. It differentiates you from competing sites during feasibility assessments.
app.clinovaiq.com/dashboard
94
Site IQ Score
94 / 100
↑ 3 pts from last audit
Compliance
100%
Active Trials
Enrolled
47
↑ 8 this mo
Documents
284
All compliant
Pfizer PF-07275315 · AD
Enrolling
BMS Deucravacitinib · PsO
Screening
AbbVie Upadacitinib · AA
IRB Pending
Specialties
Every specialty.
One platform.
From dermatology to oncology to cardiology — we add new specialties through configuration alone. Ready for your trial in days, with no extra development cost.
🔬
Dermatology
Atopic Dermatitis · Psoriasis · Hidradenitis Suppurativa · Alopecia Areata · Vitiligo
🧬
Oncology
RECIST 1.1 · ECOG · NCI-CTCAE · Solid Tumors · Hematologic
🧠
CNS / Psychiatry
Depression · Alzheimer's · Schizophrenia · HAMD · MMSE · PANSS
💊
Endocrinology
Type 2 Diabetes · Obesity · GLP-1 trials · HbA1c tracking · NASH
❤️
Cardiology
Heart Failure · NYHA · MACE endpoints · Atrial Fibrillation
🦴
Rheumatology
Rheumatoid Arthritis · DAS28 · ACR20/50/70 · Psoriatic Arthritis
👁️
Ophthalmology
BCVA · OCT · Macular Degeneration · Diabetic Retinopathy
🌍
Any Specialty
Don't see your specialty? We add new ones through configuration — typically ready for your trial in days, with no extra development cost.
Compliance
Sponsors won't select a site they can't trust.
ClinovaIQ is built compliance-first. Every feature is designed to pass FDA inspection, not just to look good in a demo.
  • ✓ Immutable audit log — every action recorded, nothing deleted, ever
  • ✓ 21 CFR Part 11 e-signatures — re-authentication on every sign event
  • ✓ HIPAA-compliant PHI encryption — AES-256, per-tenant keys in Azure Key Vault
  • ✓ TMF Reference Model — sponsor-standard document structure out of the box
  • ✓ Role-based access — PI, CRC, Sponsor, Monitor — right access, right people
📋
21 CFR Part 11
Electronic records & signatures fully compliant
🔒
HIPAA
PHI encrypted at rest and in transit
🏥
ICH-GCP
Good Clinical Practice guidelines built in
☁️
Azure HIPAA
Hosted on Microsoft Azure with BAA
📁
TMF Reference
Industry-standard document structure
🛡️
SOC 2
Security & availability controls in place
Pricing
Simple. Transparent.
No enterprise contracts.
Start free. Upgrade when you're ready. Cancel anytime.
Starter
$299/mo
For sites running 1–2 trials. Everything you need to pass your first sponsor audit.
  • ✓Up to 2 active trials
  • ✓eTMF document management
  • ✓Patient enrollment tracking
  • ✓21 CFR Part 11 audit trail
  • ✓Common assessments included (limited library)
  • ✕Sponsor portal
  • ✕Billing & invoicing
Get Started
Most Popular
Growth
$599/mo
For sites running 3–5 trials with sponsor relationships to manage.
  • ✓Up to 5 active trials
  • ✓Full eTMF + document versioning
  • ✓Full library of standard assessments (PASI, EASI, IGA…)
  • ✓Sponsor & Monitor portal
  • ✓Regulatory submissions tracker
  • ✓CIQ Intelligence Score
  • ✓Visit reminders & scheduling
  • ✕EDC lite — basic data capture
  • ✕Billing & invoicing module
  • ✕API access
  • ✕Custom assessment forms
Get Early Access
Pro
$999/mo
For established sites running 6+ trials with multiple sponsors.
  • ✓Unlimited active trials (fair-use)
  • ✓Everything in Growth
  • ✓EDC lite — basic data capture
  • ✓Billing & invoicing module
  • ✓API access
  • ✓Priority support
  • ✓Custom assessment forms
Get Started
Need a multi-site or SMO plan? Contact us →
Fair-use limits apply to all plans. Sites with unusually high volume or rapid scaling may be moved to a custom plan — we'll always reach out before any change.
💬
"The first platform I've seen that's actually built for how small sites operate — not how enterprise CROs wish we did."
— Principal Investigator · Miami, FL · Early Access Beta Tester
Early Access
Ready to run smarter trials?
Join the waitlist. We're onboarding Miami-area research sites first, across every specialty. Limited spots available in Q3 2026.
Request Access →
No credit card required · Setup in under 48 hours · Cancel anytime