FDA 21 CFR Part 11 Ready HIPAA Compliant GCP Compliant

Turn Every Pharmacy Into a Clinical Research Site

Solve enrollment challenges at the source. Bring research to patients' most trusted setting—their neighborhood pharmacy. FDA-compliant infrastructure, built for speed.

Sponsors & CROs

Accelerate enrollment

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Pharmacies

Become a research site

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Physicians

Refer patients

Join Network

Patients

Find trials near you

Search Trials
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The Clinical Trial Enrollment Crisis

Traditional sites can't keep up with demand—leading to massive delays and costs

86%

of trials fail to meet enrollment targets

$8M

lost per day in trial delays

6 mo

average enrollment delay

Platform Capabilities

Built to Solve Enrollment

Pharmacy-based recruitment with AI-powered matching delivers measurable advantages

60%
Faster Enrollment Potential
pharmacy network advantage vs. traditional sites
40%
Cost Reduction Opportunity
lower site activation & overhead vs. hospital sites
99.9%
Platform Uptime SLA
enterprise reliability guarantee
60,000+
U.S. Pharmacy Locations
addressable for trial deployment
Enterprise Infrastructure

Built with Enterprise-Grade Technology

Production-ready platform with regulatory compliance, AI intelligence, and enterprise scalability built-in

Security & Compliance

  • FDA 21 CFR Part 11 ready infrastructure
  • HIPAA Technical Safeguards implementation
  • Immutable audit trails with cryptographic verification
  • WebAuthn biometric authentication

AI & Intelligence

  • GPT-4/5 powered patient matching engine
  • Predictive analytics for enrollment forecasting
  • 24/7 AI patient support with sentiment analysis
  • Automated adverse event detection & reporting

Performance & Scale

  • Multi-region cloud architecture (US-deployed)
  • Real-time WebSocket sync for instant updates
  • Sub-50ms API response times
  • Auto-scaling infrastructure for peak demand

Integrations & Ecosystem

  • HL7 v2.x & FHIR R4 pharmacy integration
  • Stripe payment processing (PCI-compliant)
  • Twilio/SendGrid communications platform
  • PWA support for mobile & offline access

Solutions for Every Stakeholder

Choose your role to see how ZoraRx solves your specific challenges

For Sponsors & CROs

Reduce enrollment risk and accelerate timelines with AI-powered pharmacy recruitment

Enrollment Risk

Traditional sites frequently miss enrollment targets, causing timeline delays and budget overruns

Data Quality Issues

Manual data entry and fragmented systems lead to errors, protocol deviations, and audit findings

Regulatory Burden

Compliance documentation and audit trail management consume significant resources and slow operations

How ZoraRx Solves This

1

AI-Powered Patient Matching

GPT-5 driven screening identifies eligible patients in pharmacy networks in real-time. Predictive analytics forecast enrollment curves and flag risks before they impact your timeline.

2

Automated Data Capture

Direct pharmacy system integration (HL7/FHIR) eliminates manual entry. All data changes are automatically validated and logged with immutable audit trails.

3

Built-in Compliance

FDA 21 CFR Part 11 ready infrastructure handles audit trails, digital signatures, and regulatory reporting automatically. Export audit-ready documentation with one click.

Expected Outcomes

Faster Enrollment

Pharmacy networks provide immediate access to pre-screened patient populations, reducing time-to-enrollment

Higher Data Quality

Automated workflows and validation rules minimize human error and protocol deviations

Regulatory Confidence

Complete audit trails and compliance documentation reduce inspection preparation time

Start Your Trial

For Pharmacies

Transform your pharmacy into a revenue-generating clinical research site—with zero upfront investment

Revenue Pressure

Declining reimbursements and rising costs squeeze margins while patients seek additional value from their pharmacy

Limited Time

Staff already stretched thin with daily operations—no capacity for complex new programs requiring heavy training

Regulatory Uncertainty

Unclear how to meet clinical research compliance requirements without dedicated research coordinators

How ZoraRx Solves This

1

Zero Upfront Cost Model

No setup fees, no software licenses, no infrastructure costs. Earn per-patient compensation for trial participation. Our platform handles all technical and regulatory requirements.

2

Automated Workflows

AI-powered system guides your staff through screening, enrollment, and follow-up visits with step-by-step instructions. No GCP certification required—we provide training and ongoing support.

3

Built-in Compliance Automation

Platform automatically handles audit trails, digital signatures, and regulatory documentation. Everything you need for sponsor or FDA audits is generated and archived automatically.

Your Daily Workflow

1

Morning: AI Patient Alerts

Platform identifies eligible patients during prescription fills and flags them in your dashboard

2

Quick Screening (2 min)

AI pre-screened—you just confirm patient interest and schedule enrollment visit

3

Enrollment Visit (15 min)

Platform guides consent process, vital signs capture, and baseline data collection

4

Auto Revenue Tracking

System automatically tracks patient milestones and calculates compensation—no manual invoicing

Expected Outcomes

New Revenue Stream

Earn per-patient compensation for trial activities with no upfront investment required

Stronger Patient Relationships

Offer cutting-edge treatment access, positioning your pharmacy as a healthcare destination

Minimal Time Investment

Automated workflows designed to fit into your existing patient interaction patterns

Become a Research Site

For Physicians

Connect your patients to cutting-edge trials while earning performance-based incentives

Limited Treatment Options

Patients with complex or treatment-resistant conditions need access to investigational therapies

Referral Complexity

Traditional research sites require extensive paperwork and lack transparency on patient outcomes

Patient Tracking Burden

No visibility into trial progress or safety events once patients are referred elsewhere

How ZoraRx Solves This

1

Intelligent Trial Matching & One-Click Referrals

Search our comprehensive trial database by indication, phase, and inclusion criteria. Our AI pre-screens your patient's medical history (with consent) against trial eligibility requirements before surfacing matches. Refer patients with a single click—our system handles consent delivery, appointment scheduling with the nearest pharmacy site, and enrollment coordination. No phone calls, no paperwork loops, no waiting weeks for site coordinators to respond.

2

Complete Real-Time Patient Visibility

Your secure dashboard displays every referred patient's journey: screening status, enrollment confirmation, visit schedules, lab results, and adverse event reports. Automated alerts notify you immediately of any Grade 3+ adverse events or protocol deviations. Integration with your EHR (HL7/FHIR) means trial data flows directly into your patient chart—no duplicate documentation. You maintain continuity of care while the trial progresses, with full visibility but zero administrative overhead.

3

Transparent Performance-Based Compensation

Earn per-patient referral fees when patients successfully enroll and reach key trial milestones (enrollment, 30-day retention, completion). Our platform automatically tracks each referral's status and calculates your compensation in real-time—no manual invoicing or payment disputes. Monthly direct deposit with detailed statements showing each patient's progress. Typical referral fees range from $500-$2,000 per successfully enrolled patient depending on indication complexity and sponsor budgets.

Your Referral Workflow

1

Identify Eligible Patient (2 min)

During regular visit, you identify a patient who might benefit from investigational therapy. Log into ZoraRx portal and search trials by their condition.

2

AI Pre-Screening & Match (30 sec)

Platform analyzes patient's medical history against trial criteria and surfaces best matches ranked by eligibility score and proximity to patient's home.

3

One-Click Referral (30 sec)

Click "Refer Patient"—system sends them trial information, schedules screening call with pharmacy coordinator, and generates referral tracking ID.

4

Automatic Ongoing Updates

Receive automated notifications for enrollment, visits, safety events, and completion. Track compensation accrual in your dashboard. Maintain standard care coordination throughout.

Expected Outcomes

Better Patient Care

Provide access to novel therapies and contribute to advancing medical science

Complete Visibility

Track patient progress and safety outcomes throughout their trial participation

Fair Compensation

Earn incentives for successful referrals with transparent, automated tracking

For Patients

Access cutting-edge treatments at your local pharmacy with 24/7 AI support

Trials Far From Home

Most research sites are at academic hospitals requiring long drives and time away from work/family

Confusing Process

Complex medical terminology, consent forms, and trial procedures create anxiety and uncertainty

Safety Concerns

Worry about side effects, lack of clear information about rights and protections during trial participation

How ZoraRx Solves This

1

Trials at Your Neighborhood Pharmacy

Participate at a pharmacy location within 10 miles of your home—the same pharmacy you already visit for prescriptions. Your trial visits happen during normal pharmacy hours (no hospital waiting rooms or parking garage fees). All procedures are conducted by trained pharmacy staff you know and trust. Schedule visits around your work and family commitments. If you move or travel, we'll connect you to another pharmacy site in our network so you can continue the trial without disruption.

2

24/7 AI Patient Support + Human Backup

Our AI copilot is available anytime via mobile app, text message, or phone to answer questions in plain language—no medical jargon. Ask about side effects, visit schedules, test results, or your rights. Get instant responses at 2 AM or during lunch break. For complex medical concerns, the AI escalates you to a live nurse coordinator (available 24/7) who can contact your doctor or the principal investigator if needed. Every interaction is logged and reviewed to ensure you get accurate, supportive guidance throughout your trial journey.

3

Proactive Safety Monitoring System

Track symptoms daily through our mobile app using simple check-in questions (takes 2 minutes). Our AI analyzes your responses against safety thresholds defined by the trial protocol. If you report concerning symptoms (severe pain, allergic reactions, unexpected side effects), the system immediately alerts the pharmacy coordinator AND your referring physician. You receive a call-back within 15 minutes during business hours, or emergency protocol activation after hours if warranted. All adverse events are reported to the FDA and sponsor per regulatory requirements—your safety is tracked, documented, and acted upon in real-time, not during your next scheduled visit weeks away.

Your Safety Guarantees

1

Independent Medical Review

Every trial protocol is reviewed and approved by an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) before any patient can enroll. This independent body ensures the trial design protects your safety and rights.

2

Real-Time Safety Monitoring

Your symptoms are tracked daily. Automated alerts flag concerning patterns immediately—not at your next visit. Grade 3+ adverse events trigger mandatory safety assessments within 24 hours. You're never ignored or left waiting.

3

Emergency Stop Authority

If serious safety concerns emerge across trial participants, the Data Safety Monitoring Board (DSMB) has authority to pause or terminate the trial immediately. You will be notified within 24 hours and transitioned to appropriate standard care.

4

Compensation for Injury

In the unlikely event of trial-related injury, sponsors are contractually required to provide medical care at no cost to you. You will not be billed for treatment of any adverse events determined to be trial-related.

Your Rights & Protections

Informed Consent

Clear explanations of trial purpose, procedures, risks, and benefits before you agree to participate

Withdraw Anytime

You can leave the trial at any time for any reason without penalty or impact on your standard care

Privacy Protection

Your health information is encrypted and protected under HIPAA regulations with strict access controls

Continuous Monitoring

Your safety is monitored throughout the trial with immediate alerts for any concerning symptoms

What to Expect

Convenient Access

Participate at your local pharmacy instead of traveling to distant research hospitals

Clear Communication

AI support available 24/7 to answer questions in plain language you can understand

Proactive Safety

Continuous monitoring with immediate alerts if any safety concerns arise

Platform Workflow

How ZoraRx Works

Complete trial lifecycle management from site activation to regulatory submission

Step 1

Site Activation

Pharmacy sites onboarded in 48 hours with automated compliance verification, training modules, and system integration. Zero manual paperwork.

  • Automated regulatory documentation
  • GCP training & certification
  • HL7/FHIR pharmacy system integration
Step 2

AI Patient Matching

GPT-5 powered engine screens pharmacy patients against trial eligibility criteria in real-time. Predictive analytics identify optimal enrollment windows.

  • Real-time prescription data screening
  • Privacy-preserving de-identification
  • Automated eligibility scoring
Step 3

Enrollment & Consent

Digital consent management with WebAuthn biometric signatures. Mobile-first patient portal for screening questionnaires and baseline data collection.

  • FDA 21 CFR Part 11 compliant e-signatures
  • Multi-language consent forms
  • Automated enrollment confirmation
Step 4

Data Collection & Monitoring

Continuous data capture from pharmacy visits, wearable devices, and patient-reported outcomes. AI-powered adverse event detection with automated safety reporting.

  • Real-time WebSocket data sync
  • Wearable device integration
  • Automated AE/SAE reporting
Step 5

Compliance & Submission

Automated audit trail generation, regulatory document assembly, and submission-ready data packages. One-click export for FDA/EMA submissions.

  • Immutable audit trails
  • Automated eTMF assembly
  • Regulatory submission templates
Potential ROI

Pharmacy Sites vs. Traditional Research Centers

Compare the potential cost structure of pharmacy-based recruitment to traditional hospital sites

Site Activation Cost
ZoraRx Pharmacy Network
$0 - $2,500
Zero upfront for pharmacies
vs
Traditional Hospital Sites
$15,000 - $50,000
Per hospital site
Activation Timeline
ZoraRx Pharmacy Network
48 hours
Automated onboarding
vs
Traditional Hospital Sites
3-6 months
IRB approval & contracts
Patient Access
ZoraRx Pharmacy Network
60,000+ locations
Nationwide pharmacy network
vs
Traditional Hospital Sites
Limited reach
Urban academic centers
Enrollment Speed
ZoraRx Pharmacy Network
60% faster
AI matching + pharmacy access
vs
Traditional Hospital Sites
Baseline
Manual recruitment efforts
Compliance Management
ZoraRx Pharmacy Network
Fully Automated
Built-in FDA 21 CFR Part 11
vs
Traditional Hospital Sites
Manual processes
Dedicated compliance staff
Total Cost Per Patient
ZoraRx Pharmacy Network
40% lower
Reduced overhead & automation
vs
Traditional Hospital Sites
Baseline
Traditional site costs

Note: Cost and timeline advantages are projected estimates based on pharmacy network characteristics vs. traditional academic medical centers. Actual results will vary by trial complexity, therapeutic area, and geographic distribution. Contact us for a customized analysis based on your specific trial parameters.

Get Custom ROI Analysis
Success Stories

Trusted by Healthcare Leaders

Hear from sponsors, pharmacies, physicians, and patients transforming clinical research

"We reduced patient screening time by 35% using ZoraRx's pharmacy network. The AI matching engine identified qualified candidates we would have missed through traditional recruitment methods. Implementation took just 2 weeks."

SC
Sarah Chen
Director of Clinical Operations
MidPharm Research Group
Sponsor

"Becoming a research site generated $18,000 in additional annual revenue while allowing us to better serve our community. The platform handles all compliance documentation automatically, so we focus on patient care."

MR
Michael Rodriguez, PharmD
Owner & Clinical Pharmacist
Corner Pharmacy, San Antonio TX
Pharmacy

"I can now refer patients to trials at their neighborhood pharmacy instead of sending them across town to a research center. The portal makes referrals simple, and I receive real-time updates on patient progress."

JP
Dr. James Patterson
Primary Care Physician
Austin Family Medicine
Physician

"Finding a diabetes trial at my local pharmacy was life-changing. I trust my pharmacist, and having study visits during my regular prescription pickups made participation easy. The app kept me informed every step of the way."

LT
Linda Thompson
Type 2 Diabetes Trial Participant
Houston, TX
Patient

"The immutable audit trails and automated 21 CFR Part 11 compliance saved us significant resources during our FDA inspection. What used to take weeks of preparation now happens automatically. Our auditors were impressed."

DK
David Kim, PhD
VP of Regulatory Affairs
Novus BioPharma
Sponsor

"Training our staff took only 3 hours, and the platform guided us through every step. Within a month, we enrolled 8 patients in our first study. It's rewarding to offer cutting-edge treatment options to our patients."

AP
Anita Patel, PharmD
Clinical Pharmacy Manager
HealthPlus Pharmacy Network
Pharmacy
Try It Now - No Signup Required

Find Your Perfect Clinical Trial Match

Our AI instantly matches you with relevant trials based on your condition and location

Search Clinical Trials

Enter your medical condition and location to discover matching trials

Demo Mode: This is a demonstration of our AI-powered trial matching system. Real trials are available after signup.

About ZoraRx Trials

Our Mission

To democratize access to clinical trials by bridging the gap between patients, community pharmacies, and pharmaceutical innovation. We leverage artificial intelligence, predictive analytics, and pharmacy networks to accelerate patient recruitment while maintaining the highest standards of regulatory compliance and data integrity.

Company Overview

ZoraRx Trials is a clinical research technology company that transforms community pharmacies into FDA-compliant research sites. Headquartered in San Antonio, Texas, we're built to serve pharmaceutical sponsors, contract research organizations, and healthcare providers across North America with cutting-edge enrollment solutions and regulatory compliance infrastructure.

Leadership

50+ years combined expertise in pharmaceutical R&D, clinical operations, regulatory affairs, and enterprise healthcare technology from Fortune 500 leaders.

Certifications & Compliance

FDA 21 CFR
Part 11 Ready
HIPAA
Technical Safeguards
GCP
Compliant
SOC 2
Type II Ready

Frequently Asked Questions

Find answers to common questions about our platform

How quickly can we start a trial?

Most sponsors are fully operational within 48-72 hours. Our streamlined onboarding includes automated site activation, compliance verification, and pharmacy network integration. We handle all regulatory documentation and system configuration, allowing you to begin patient recruitment quickly.

Is ZoraRx Trials FDA compliant?

Yes, ZoraRx Trials is built with FDA 21 CFR Part 11 readiness from the ground up. Every action is automatically logged with immutable audit trails, cryptographic verification, and digital signature management. We're also HIPAA compliant, GCP compliant, and ready for SOC 2 Type II auditing. Our platform undergoes regular security assessments and maintains comprehensive compliance documentation for regulatory inspections.

How does pricing work?

We offer flexible pricing based on trial size, duration, and therapeutic area. Pharmacy sites join at zero upfront cost and receive per-patient compensation. Sponsors can choose from subscription-based plans or per-trial licensing. Contact us for a custom quote tailored to your specific needs.

What support is provided?

All users receive 24/7 AI-powered support, comprehensive training materials, and dedicated account management. Sponsors receive regulatory consultation, protocol optimization guidance, and enrollment strategy planning. Pharmacies receive step-by-step onboarding assistance, technical training, and ongoing operational support. Enterprise customers have access to priority support with guaranteed response times.

Can we integrate with existing systems?

Yes, ZoraRx Trials integrates seamlessly with major CTMS platforms (Medidata Rave, Oracle Clinical, Veeva Vault CTMS), EDC systems (Medidata Rave EDC, REDCap), and LIMS via HL7 FHIR, REST API, and secure SFTP connections. Our technical team handles the integration process, including data mapping, validation, and ongoing synchronization.

Ready to Transform Clinical Trial Enrollment?

Join the future of decentralized trials with AI-powered pharmacy recruitment. Start today.

Start Your Trial Schedule a Demo

No credit card required • Quick setup • Cancel anytime

Get in Touch

Ready to transform your clinical trial enrollment? Contact our team today.

Phone
726-800-6647
Fax
726-800-7729
Headquarters
607 S WW White Rd
San Antonio, TX 78220
United States
Get Started Today