What is AccuraTrials?

AccuraTrials is an AI-native Electronic Data Capture (EDC) with a built-in AI developer. It reduces study build times from months to days by generating eCRFs from protocol PDFs and suggesting validation rules from plain English. Full 21 CFR Part 11 compliance with no programmer dependency.

How does AccuraTrials reduce build times?

AccuraTrials reduces build times by using AI to generate eCRF drafts from protocol PDFs in minutes and suggest validation logic from plain-English descriptions in seconds — all for human review before activation.

How does AccuraTrials support inspection readiness?

AccuraTrials supports inspection readiness with an AI Copilot that catches data anomalies in real-time before forms are saved, and an Audit Trail AI that scans millions of log entries to surface risk patterns that manual monitoring misses — reducing the documentation gaps that lead to inspection findings.

Is AccuraTrials 21 CFR Part 11 compliant?

Yes. AccuraTrials is built for 21 CFR Part 11 compliance. Every electronic signature requires credential re-authentication. Every data change writes to an immutable, tamper-evident audit trail with timestamp, user, prior value, new value, and reason.

How long does study setup take with AccuraTrials?

AccuraTrials accelerates study setup. The AI protocol parser generates eCRF drafts from a protocol PDF in minutes for your review, and the 8-tab study wizard handles sites, visits, randomization, and permissions in a single session. Launch timing depends on your review and validation process.

Does AccuraTrials require a dedicated EDC programmer?

No. AccuraTrials is entirely no-code. The AccuraTrials Form Builder, Validation Rule Builder, and Branching Logic editor are all visual interfaces. The AccuraTrials AI Rule Suggester lets you describe a constraint in plain English and it proposes the edit check logic automatically.

Who is AccuraTrials for?

AccuraTrials serves academic medical centers, biotech startups, contract research organizations (CROs), pharmaceutical sponsors, and clinical research sites running Phase I through Phase IV and observational studies.

What export formats does AccuraTrials support?

AccuraTrials supports PDF, Microsoft Excel, CSV, ODM XML (CDISC standard), and tab-delimited export. AccuraTrials includes a dedicated regulatory export endpoint for FDA and EMA submission packages with complete audit trails.

How does randomization work in AccuraTrials?

AccuraTrials supports stratified randomization with configurable stratification factors, sealed allocation lists, and an emergency unblinding workflow with credential re-authentication and audit capture. AccuraTrials RTSM/IRT kit and shipment tracking is integrated.

Where is AccuraTrials based?

AccuraTrials is based in Madison, Wisconsin, USA. AccuraTrials was founded by James Gui to make enterprise-grade clinical trial EDC technology accessible to research teams of all sizes.

Privacy Policy

Effective Date: May 10, 2026

1. Introduction

AccuraTrials LLC ("we," "us," or "our") operates the AccuraTrials electronic data capture platform at accuratrials.com and app.accuratrials.com. This Privacy Policy describes how we collect, use, store, and protect information from visitors to our marketing website and users of our clinical trial platform.

2. Information We Collect

2.1 Website Visitors

When you visit accuratrials.com or submit a demo request form, we may collect:

Name, email address, and organization name (from contact forms)
Role and study type (from demo request forms)
Browser type, IP address, and pages visited (via server logs)

2.2 Platform Users

When your organization uses the AccuraTrials EDC platform, we process:

User authentication credentials (email, encrypted password)
Audit trail records (username, timestamp, action, IP address)
Session metadata (device fingerprint, login/logout times)
Clinical trial data entered by your organization's authorized users

2.3 Clinical Trial Data

Clinical trial data (including subject data, CRF entries, queries, and electronic signatures) is entered and managed by your organization. We act as a data processor on behalf of your organization (the data controller). We do not access clinical data except as necessary to operate and maintain the platform.

3. How We Use Information

We use collected information to:

Respond to demo requests and sales inquiries
Provide and maintain the AccuraTrials platform
Enforce access controls and security measures
Maintain audit trails required for regulatory compliance
Send service-related communications (system updates, security alerts)
Improve platform functionality and performance

We do not sell your personal information. We do not use clinical trial data for advertising or marketing purposes.

4. Data Security

We implement industry-standard security measures including:

Encryption in transit (TLS 1.2+) and at rest (AES-256)
Role-based access controls with 28 granular permission levels
Session management with idle timeouts and device fingerprinting
Immutable audit trails for all data modifications
Regular security assessments and infrastructure monitoring
Encrypted backups with key rotation

5. Data Retention

Website inquiry data is retained for up to 24 months after your last interaction. Clinical trial data is retained according to your organization's configured retention policies and applicable regulatory requirements (typically 15+ years for FDA-regulated studies). Audit trail records are retained permanently and cannot be deleted.

6. Data Sharing

We do not share your data with third parties except:

Infrastructure providers necessary to operate the Service (cloud hosting, database services)
When required by law, regulation, or valid legal process
With your organization's explicit written consent

7. HIPAA Compliance

For organizations subject to HIPAA, AccuraTrials supports Protected Health Information (PHI) handling through field-level PHI designation, role-scoped access controls, and comprehensive access audit trails. Business Associate Agreements (BAAs) are available upon request.

8. GDPR Compliance

For users in the European Economic Area, you have the right to:

Access your personal data
Request correction of inaccurate data
Request deletion of your data (subject to regulatory retention requirements)
Object to processing of your data
Request data portability

To exercise these rights, contact us at jgui@accuratrials.com. Note that clinical trial audit trail data cannot be deleted due to regulatory requirements (21 CFR Part 11, ICH E6 GCP).

9. Cookies and Tracking

Our marketing website uses essential cookies for session management. We do not use third-party advertising trackers. The platform application uses authentication cookies and session tokens necessary for secure operation.

10. Children's Privacy

The Service is not directed at individuals under 18 years of age. We do not knowingly collect personal information from children. Clinical trial subject data involving minors is entered by authorized clinical staff, not by minors themselves.

11. Changes to This Policy

We may update this Privacy Policy from time to time. Changes will be posted on this page with an updated effective date. We will notify platform users of material changes via email or in-app notification.

12. Contact

For privacy-related questions or to exercise your data rights, contact:

AccuraTrials LLC
Madison, Wisconsin, United States
jgui@accuratrials.com