Real-World Evidence Through Patient Engagement
Transform clinical trial data collection with gamified, mobile-first experiences that participants actually want to use. Capture medication adherence, vitals, PROs, and adverse events in real-time.
Why Leo for Clinical Trials
Leverage Leo's proven health tracking platform to capture high-quality, real-world evidence with exceptional participant engagement.
Mobile-First Experience
Native iOS app with Apple Watch support--participants can track their health from anywhere, anytime
Medication Adherence
NFC stickers for one-tap dose logging, smart reminders, and photo confirmation so you never miss a dose
Real-Time Vitals
Automatic sync from Apple Watch and HealthKit--heart rate, activity, sleep data flows directly to your study team
Gamified Engagement
Earn points, unlock badges, and maintain streaks for staying on track--making participation fun and engaging
Patient-Reported Outcomes
Easy surveys to share how you're feeling, with reminders to ensure your voice is heard in the research
FDA-Ready Compliance
Meets 21 CFR Part 11 standards--your electronic signatures and data are legally valid and tamper-proof
Trial-Specific Capabilities
Beyond standard Leo features, our clinical trials platform includes specialized tools for regulatory compliance and sponsor visibility.
Electronic Informed Consent
Understand your study through interactive content, videos, and quizzes--then sign securely from your phone with legally valid digital signatures.
Side Effect Reporting
Easily report how you're feeling with guided questions. Your study team is immediately notified of any concerns, ensuring your safety comes first.
Smart Visit Reminders
Never miss an appointment with automated reminders. Track your study schedule and get notified when it's time for check-ins or assessments.
Sponsor & Site Dashboards
Research teams see real-time enrollment progress, participant compliance, and safety signals--enabling faster decisions and better outcomes.
Medication Tracking
Log when you receive study medications, track your supply, and confirm each dose taken--ensuring accurate accountability throughout your trial.
Connect Your Devices
Link glucose monitors, blood pressure cuffs, pulse oximeters, and fitness trackers to automatically share health data with your study team.
Designed for Modern Clinical Research
Whether you're running traditional site-based trials or fully decentralized studies, Leo adapts to your protocol requirements while maximizing participant engagement and data quality.
Real-Time Trial Dashboard
Compliance & Security
Built from the ground up for pharmaceutical regulatory requirements with complete audit trails and data integrity.
HIPAA Coming Soon
Your health data is protected
FDA Validated
Meets 21 CFR Part 11 standards
GDPR Ready
European privacy compliant
Enterprise Security
SOC 2 Type II certification path
Standard Exports
CDISC-ready for regulators
Your Own Custom Web Portal
Each organization gets a completely isolated web application with their own custom domain--ensuring complete data separation and regulatory compliance.
100% Data Isolation
Each trial runs on its own Firebase project with completely separate databases, authentication, and storage--no data mixing, ever.
TLS 1.3 Encryption
All data in transit is encrypted with TLS 1.3 using AES-256-GCM cipher suites. Automatic SSL certificates for all custom domains.
AES-256 At Rest
All stored data is encrypted at rest using AES-256 with Google-managed keys. Optional customer-managed keys (CMEK) for enterprise.
Enterprise Security
Built on Google Cloud's certified infrastructure (SOC 2, ISO 27001). HIPAA BAA in progress. Leo SOC 2 audit planned.
White-Label Options
Custom branding with your organization's logo, colors, and favicon. Optional fully custom domain (trials.your-company.com).
Independent Backups
Each trial has independent backup and disaster recovery policies. Point-in-time recovery ensures data integrity.
Complete Infrastructure Isolation
Learn More
Explore how Leo Clinical Trials can help your organization
See Leo for Research in Action
Explore our powerful tools for survey creation, site management, and data collection.
Weekly Symptom Assessment
4 questions • Scheduled: Every Monday
Branching Logic
If answer ≥ 3, show follow-up question about symptom impact
Leo for Research is currently in development. Join our early access program to be among the first to use these powerful tools.
Request Early AccessThe Participant Experience
From enrollment to completion, see how Leo transforms the study participation experience.
Receive Invite
Get study link via email or QR code
E-Consent
Review study info, watch videos, sign digitally
Download App
Install from App Store (unlisted, private link)
Daily Tasks
Complete surveys, log symptoms, sync wearables
Earn Rewards
Collect points, badges, and compensation
Everything You Need for Modern Research
Survey Builder
- Validated instruments (PHQ-9, GAD-7, SF-36)
- Custom question types
- Branching logic
- Scheduling & reminders
Data Collection
- Apple Watch & HealthKit sync
- Photo/video capture
- Voice recording
- Location tracking
Site Tools
- Enrollment tracking
- Compliance monitoring
- Query management
- Messaging system
Sponsor Dashboard
- Cross-site analytics
- Real-time data export
- Safety signal monitoring
- Study configuration
Compliance
- 21 CFR Part 11 ready
- Immutable audit trails
- Electronic signatures
- CDISC export
Engagement
- Points & badges
- Streak rewards
- Gift card integration
- Leaderboards
E-Consent
- Interactive documents
- Video explanations
- Comprehension quizzes
- Version control
Wearables
- Apple Watch
- Fitbit
- Garmin
- Oura Ring
Transparent Pricing
Simple per-participant pricing that scales with your study. No hidden fees.
Basic
Essential data collection
- Custom surveys
- Basic dashboards
- Email support
- CSV export
Standard
Full platform capabilities
- Everything in Basic
- Wearable integration
- Safety alerts
- Gamification
- Phone support
Enterprise
Complete research platform
- Everything in Standard
- E-consent module
- API access
- Custom integrations
- Dedicated CSM
- Validation package
All plans include setup support. Volume discounts available for studies with 500+ participants.
Glossary of Key Terms
Clinical research has specialized terminology. Here's what the key terms on our platform mean in plain language.
PRO (Patient-Reported Outcomes)
Information about your health that you provide directly--like how you're feeling, pain levels, or quality of life. It's your voice in the research, captured through surveys and questionnaires.
21 CFR Part 11
FDA regulations that ensure electronic records and signatures are trustworthy and equivalent to paper records. This means your digital signatures and data are legally valid and tamper-proof.
CDISC (SDTM/ADaM)
Standard formats for organizing clinical trial data so it can be shared with regulatory agencies worldwide. Think of it as a universal language for trial data that FDA and other agencies understand.
eConsent
Electronic informed consent--a digital way to learn about and agree to participate in a study. It often includes videos, quizzes to check understanding, and secure digital signatures.
Adverse Event (AE/SAE)
Any unwanted health effect during a study. A Serious Adverse Event (SAE) is one that's severe, like hospitalization. Reporting these helps ensure medications are safe.
DCT (Decentralized Clinical Trial)
A modern trial approach where you can participate from home using apps and wearables, with medications shipped to you directly--reducing or eliminating clinic visits.
MedDRA Coding
A standardized medical dictionary used worldwide to classify symptoms and side effects. It ensures everyone uses the same terms, making safety data comparable across studies.
Real-World Evidence (RWE)
Health data collected outside traditional clinical trials--from apps, wearables, and daily life. It shows how medications work in real-world conditions, not just controlled settings.
Protocol Deviation
When something in the study happens differently than planned--like a missed visit or dose. Tracking these helps maintain data quality and participant safety.
Ready to Transform Your Clinical Trials?
Schedule a demo to see how Leo can improve participant engagement, data quality, and regulatory compliance for your next trial.