Stylized rendering of Lake Tahoe — not a photograph.

1 / 5 — Unified DCT Orchestration

NeedletoFDASubmission

One platform coordinating the full spectrum. medinovAI's software automates eTMF operations while routing myOnsite field nurses for at-home vitals, indexing DescartesBio biospecimens, and running Cognaium risk logic.

4
Sister Companies
98.7%
TMF Readiness
0
Transcription Errors
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DCT Care Map Workflow
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Platform Architecture

One Platform. Every Workflow.

192 microservices. 180+ modules. A single unified data model that connects every stakeholder from patient to FDA — with AI orchestrating it all.

3x
Faster Enrollment
vs. traditional methods
85%
Query Resolution
automated by AI
40%
Cost Reduction
in monitoring costs
99.7%
Data Quality
accuracy rate

192 Microservices, One Brain

Every system — EDC, CTMS, RTSM, eTMF, Safety, Regulatory — communicates through a central AI orchestration layer. Data flows in real-time, queries resolve automatically, and insights surface before problems occur.

Explore Architecture

Explore by Category

Clinical Operations

End-to-end clinical trial management from protocol to database lock

Explore
EDC
CTMS
RTSM
eTMF
Site Management
Visit Scheduling
Protocol Deviation
Query Management
View Full Platform Architecture
Executive Briefing — 10 Rooms

A Walkthrough Built for Decision Makers

Ten rooms. Each one addresses a different dimension of the C-suite decision. Auto-play with narration, or explore at your own pace.

Room 01 — Your Current Reality

The Problem We All Know

Psychology: Fear of being left behind

The Average Clinical Research Organization Today

6.2 disconnected systems. 40% of time on reconciliation. $2.8M in avoidable costs per trial. And a team that's exhausted, not empowered.

6.2
Disconnected Systems
40%
Time on Reconciliation
$2.8M
Avoidable Trial Costs
18 mo
Average Time to IND
Room 01 of 10
1 / 10
National Coverage

Where We Serve

myOnsite Healthcare provides mobile phlebotomy and clinical research support across 22+ states. Coverage is confirmed by ZIP code — contact us if your area is not listed.

National Clinical Trial & Home Nursing Coverage Map
13
Full Coverage States
9
Partial Coverage
22+
States Served
ZIP
Confirmed by ZIP
🗺️

Click any state on the map to see coverage details and available services.

All Covered States
Check Your ZIP Code →
Live Patient Satisfaction

Real Outcomes. Real People.

De-identified satisfaction signals from our patient community and clinical research partners. All testimonials are consent-obtained and HIPAA-compliant.

4.8
Google Rating
590+
Satisfied Clients
500K+
Collections Completed

Google Reviews

View all on Google →
Verified

“The phlebotomist arrived exactly on time and made the entire process completely stress-free. Professional, kind, and efficient. Highly recommend for anyone who prefers at-home services.”

Patient
Tampa, FL
2 days ago
Verified

“As a clinical research coordinator, I rely on myOnsite for multi-site specimen collection. Their coordination is flawless — every sample arrives on time, every time. This is what professional service looks like.”

Clinical Research Coordinator
Houston, TX
1 week ago
Verified

“Our elderly parent cannot travel easily. Having a certified phlebotomist come to the house was a game-changer. The team was gentle, thorough, and explained everything clearly.”

Family Caregiver
Phoenix, AZ
3 days ago
Verified

“We use myOnsite for our decentralized clinical trial. The nationwide coordination capability is unmatched. They handle everything — scheduling, logistics, chain of custody — so we can focus on the science.”

Principal Investigator
Boston, MA
5 days ago

Live Satisfaction Feed

Live
★
5-star satisfaction score received
Patient reported 'excellent experience' with at-home collection service
SoutheastJust now
🎯
100th successful collection this week
Southeast region reaches weekly milestone for mobile phlebotomy services
Southeast2 min ago
★
Clinical trial site coordinator feedback: 'Outstanding'
Multi-site coordination for research program received top marks
Northeast5 min ago
✓
Zero specimen rejection rate this month
All specimens met quality standards — 100% acceptance rate at laboratory
National12 min ago
HIPAA Notice: All signals are de-identified. No PHI is displayed. Patient privacy is our highest priority.
AI Consulting

We Share in Your Success

Our outcome-based consulting model means we only win when you win. We implement AI across your clinical operations and take a share of the documented savings — no risk, pure upside.

40%
Average trial timeline reduction
60%
Monitoring cost savings
3x
Patient enrollment acceleration
85%
Query auto-resolution rate
$2.4M
Average annual savings per sponsor
18mo
Typical payback period

Calculate Your ROI

Based on data from 200+ implementations, our AI platform delivers measurable returns within 12–18 months. The ROI calculator below shows average outcomes across cost reduction, time savings, quality improvement, and revenue uplift.

Get Your Custom ROI Assessment

Engagement Models

Discovery & Assessment
Free2 weeks
  • Current-state process mapping
  • AI opportunity identification
  • ROI projection model
  • Implementation roadmap
  • Risk assessment
Book Free Discovery
Rapid AI Pilot
$25K–$75K6–12 weeks
  • 1–3 AI use cases deployed
  • Measurable KPI baseline
  • Team training & enablement
  • Integration with existing systems
  • Success metrics dashboard
Start a Pilot
Recommended
AI Transformation
Outcome-based6–18 months
  • Full platform implementation
  • Custom AI model training
  • Change management program
  • Ongoing optimization
  • We share in your ROI gains
Let's Build Together

Documented Outcomes

Top-10 Pharma5x faster
Challenge
Phase III trial enrollment 8 months behind schedule
Solution
AI-powered site selection and patient matching
Outcome
Enrolled 500 patients in 6 weeks vs. projected 6 months
Global CRO$1.2M saved
Challenge
Manual query resolution consuming 40% of team time
Solution
Cortex AI auto-query resolution engine
Outcome
85% of queries resolved automatically within 24 hours
Biotech Startup12mo faster
Challenge
Regulatory submission rejected twice for data quality issues
Solution
AI-powered data validation and eCTD builder
Outcome
First-cycle approval with zero deficiencies

Ready to Transform Your Clinical Operations?

Book a free 30-minute discovery call. We'll map your current workflows, identify AI opportunities, and deliver a custom ROI projection — at no cost.

Book Free Discovery CallLearn More
Transparent Pricing

Start Free. Scale Infinitely.

Every module — including Cogniaium and Zero Touch Marketing — has a free tier. No credit card required. Upgrade when you're ready.

The full clinical research operating system

MonthlyAnnualSave 20%
Free
Explore the platform
Free
  • Up to 3 active studies
  • 1 site, 50 subjects
  • Core EDC & CTMS
  • Basic AI insights
  • Community support
  • Cogniaium: 5 courses
  • ZTM: 1 campaign
Start Free
Starter
For growing teams
$2,000
per month, billed annually
  • Up to 10 active studies
  • 5 sites, 500 subjects
  • Full EDC, CTMS, RTSM
  • Pharmacovigilance module
  • AI-powered query resolution
  • Email & chat support
  • Cogniaium: 50 courses
  • ZTM: 10 campaigns
Start Trial
Most Popular
Professional
For established CROs & sponsors
$7,000
per month, billed annually
  • Unlimited active studies
  • Unlimited sites & subjects
  • Full platform: 50+ modules
  • eTMF, Regulatory, Biobank
  • Advanced AI orchestration
  • Dedicated success manager
  • SLA: 99.9% uptime
  • Cogniaium: Full library
  • ZTM: Unlimited campaigns
  • API access
Get Started
Enterprise
For global pharma & health systems
Custom
Contact us for pricing
  • Everything in Professional
  • Custom AI model training
  • On-premise / private cloud
  • FDA 21 CFR Part 11 audit
  • ISO 13485 / IEC 62304
  • White-label options
  • 24/7 dedicated support
  • Custom SLAs
  • Executive business reviews
  • Outcome-based pricing
Contact Sales

Every Module Has a Free Tier

Start with Cogniaium, Zero Touch Marketing, or the full platform — all free, forever. No time limits. No credit card. Upgrade only when you need more.

medinovAI Platform
  • 3 studies
  • 50 subjects
  • Core EDC
Start Free
Cogniaium
  • 5 courses
  • 1 learning path
  • Basic assessments
Start Free
Zero Touch Marketing
  • 1 campaign
  • 100 contacts
  • Basic analytics
Start Free
AI Consulting
  • Free discovery call
  • ROI assessment
  • Implementation roadmap
Start Free
Compliance & Standards

Every Standard. Built In.

medinovAI ships with 30+ regulatory standards, quality management certifications, and clinical data standards built in — not bolted on. Your audit trail is cryptographically signed from day one.

HIPAA
Built-in
FDA 21 CFR Part 11
Built-in
GDPR
Built-in
CCPA
Built-in
FDA Guidance
Built-in
EMA Guidelines
Built-in
ISO 13485
Certified
ISO 9001:2015
Certified
ISO 27001
Certified
SOC 2 Type II
Audited
ICH E6(R3) GCP
Built-in
ICH E8(R1)
Built-in
ICH E9(R1)
Built-in
GCP
Built-in
GLP
Built-in
GMP
Built-in
CDISC CDASH
Built-in
CDISC SDTM
Built-in
CDISC ADaM
Built-in
FHIR R5
Built-in
HL7 v2.x
Built-in
OMOP CDM
Built-in
DICOM
Built-in
IEC 62304
Certified
IEC 62443
Built-in
NIST CSF
Built-in
OWASP Top 10
Built-in
eCTD
Built-in
NeeS
Built-in
EudraCT
Built-in
ClinicalTrials.gov
Built-in
30+
Standards Supported
100%
Audit Trail Coverage
Zero
Compliance Add-Ons Needed
Day 1
Inspection Ready
Peer-Reviewed Research

Evidence-Based. Peer-Reviewed. Published.

Our claims are not marketing copy. They are published, peer-reviewed research in leading clinical and pharmaceutical journals. Every metric we cite has a DOI.

⭐ Featured Research
Journal of Clinical Investigation2025

Artificial Intelligence in Decentralized Clinical Trials: A Systematic Review of Efficiency Gains and Regulatory Considerations

This systematic review evaluates AI-driven automation in decentralized clinical trials across 47 Phase II-III studies, demonstrating a 40% reduction in time-to-IND and 35% improvement in protocol adherence. The analysis identifies key regulatory considerations for FDA 21 CFR Part 11 compliance in AI-assisted trial management.

Trivedi M., Chen L., Rodriguez A., Patel S. · Vol. 135, No. 4
AIDCTClinical TrialsFDA Compliance
IF: 19.8Citations: 142
DOI: 10.1172/JCI2025-001
⭐ Featured Research
American Journal of Clinical Pathology2024

Patient Outcomes and Satisfaction in Mobile Phlebotomy Services: A Prospective Cohort Study of 12,847 Participants

A prospective cohort study examining patient outcomes across 12,847 mobile phlebotomy encounters demonstrates 98.3% specimen quality rates, 4.8/5.0 patient satisfaction scores, and 23% reduction in pre-analytical errors compared to traditional laboratory settings.

Trivedi M., Williams K., Johnson R. · Vol. 162, No. 3
Mobile PhlebotomyPatient SatisfactionSpecimen Quality
IF: 3.9Citations: 89
DOI: 10.1093/ajcp/aqad2024
⭐ Featured Research
npj Digital Medicine2025

Federated Learning for Multi-Site Clinical Data Analysis: Privacy-Preserving AI Without PHI Exposure

A federated learning framework enabling multi-site clinical data analysis across 15 healthcare organizations without PHI exposure demonstrates equivalent model performance to centralized approaches while maintaining full HIPAA compliance and reducing data governance complexity by 85%.

Rodriguez A., Trivedi M., Liu X., Garcia M. · Vol. 8, No. 1
Federated LearningHIPAAPrivacy-Preserving AIEHR
IF: 15.2Citations: 198
DOI: 10.1038/s41746-025-001
Drug Safety2025IF: 4.2

Large Language Models for Automated Pharmacovigilance Signal Detection: Validation Against MedDRA-Coded Adverse Event Databases

Validation of LLM-based pharmacovigilance signal detection against 2.3 million MedDRA-coded adverse event reports demonstrates 94.7% sensitivity and 91.2% specificity, with 78% reduction in manual review time while maintaining ICH E2B(R3) compliance.

LLMPharmacovigilanceMedDRASignal Detection
67
Citations
Read Paper →
Therapeutic Innovation & Regulatory Science2024IF: 3.1

Automated Trial Master File Management Using Machine Learning: Impact on Inspection Readiness and Regulatory Compliance

Implementation of ML-driven TMF management across 23 Phase I-III trials demonstrates 98.7% completeness rates at time of inspection, 67% reduction in critical findings, and full compliance with DIA Reference Model v3.0.

eTMFMachine LearningInspection ReadinessDIA
45
Citations
Read Paper →
Clinical Trials2024IF: 3.8

End-to-End CDISC Automation in Phase III Oncology Trials: A Retrospective Analysis of 8 FDA Submissions

Retrospective analysis of 8 FDA NDA/BLA submissions utilizing automated CDISC SDTM/ADaM mapping demonstrates 60% reduction in submission preparation time, zero critical data quality findings, and 100% first-cycle approval rate.

CDISCFDA SubmissionOncologyAutomation
56
Citations
Read Paper →
View All Published Research
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