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.

Terms of Service

Effective Date: May 10, 2026

1. Acceptance of Terms

By accessing or using AccuraTrials ("the Service"), operated by AccuraTrials LLC ("we," "us," or "our"), you agree to be bound by these Terms of Service. If you do not agree to these terms, do not use the Service.

2. Description of Service

AccuraTrials is an AI-powered electronic data capture (EDC) platform designed for clinical trial data management. The Service provides tools for building electronic case report forms (eCRFs), configuring validation rules, managing queries, capturing electronic signatures, and maintaining audit trails in support of 21 CFR Part 11 compliant workflows.

3. Eligibility

The Service is intended for use by clinical research professionals, organizations conducting clinical trials, contract research organizations (CROs), academic medical centers, biotech and pharmaceutical companies, and their authorized personnel. You must be at least 18 years old to use the Service.

4. User Accounts and Access

Access to the AccuraTrials platform requires authentication credentials issued by your organization's administrator. You are responsible for maintaining the confidentiality of your login credentials. You must not share your credentials with any other person. All actions taken under your account are your responsibility.

We enforce session management controls including idle timeouts and device fingerprinting as part of our regulatory compliance framework.

5. Acceptable Use

You agree to use the Service only for lawful purposes in connection with legitimate clinical research activities. You shall not:

Attempt to gain unauthorized access to the Service or its systems
Interfere with audit trail integrity or data lock mechanisms
Use the Service to store data unrelated to clinical research
Reverse engineer, decompile, or disassemble any part of the Service
Circumvent electronic signature or authentication controls
Upload malicious code or attempt to compromise system security

6. Clinical Data and Regulatory Compliance

AccuraTrials is designed to support workflows consistent with 21 CFR Part 11, ICH E6(R2) GCP, HIPAA, and GDPR requirements. However, ultimate responsibility for regulatory compliance rests with the sponsoring organization and its qualified personnel. AccuraTrials provides the technical infrastructure; your organization is responsible for validation, standard operating procedures, and regulatory submissions.

7. AI-Powered Features

AccuraTrials includes AI-powered features such as the Rule Suggester, Protocol Parser, and Anomaly Detection Copilot. These features provide suggestions and recommendations only. All AI outputs require human review and approval before taking effect. AI suggestions are logged in the immutable audit trail for full regulatory transparency.

AI features do not constitute medical advice, clinical judgment, or regulatory guidance.

8. Data Ownership

You retain all rights to your clinical trial data. We do not claim ownership of any data you enter into the Service. Your data is stored securely with encryption at rest and in transit. We will not access your data except as necessary to provide the Service or as required by law.

9. Service Availability

We strive to maintain high availability of the Service but do not guarantee uninterrupted access. Scheduled maintenance windows will be communicated in advance. We are not liable for any damages resulting from service interruptions.

10. Limitation of Liability

To the maximum extent permitted by law, AccuraTrials LLC shall not be liable for any indirect, incidental, special, consequential, or punitive damages, including loss of data, revenue, or profits, arising from your use of the Service.

The Service is provided "as is" without warranties of any kind, either express or implied, including but not limited to implied warranties of merchantability or fitness for a particular purpose.

11. Indemnification

You agree to indemnify and hold harmless AccuraTrials LLC from any claims, damages, or expenses arising from your use of the Service, your violation of these Terms, or your violation of any applicable law or regulation.

12. Modifications to Terms

We reserve the right to modify these Terms at any time. Changes will be posted on this page with an updated effective date. Continued use of the Service after changes constitutes acceptance of the revised Terms.

13. Termination

We may suspend or terminate your access to the Service at any time for violation of these Terms or for any reason at our sole discretion. Upon termination, your right to use the Service ceases immediately. Data retention and export options will be provided in accordance with our data management policies.

14. Governing Law

These Terms are governed by the laws of the State of Wisconsin, United States, without regard to conflict of law principles. Any disputes shall be resolved in the courts of Dane County, Wisconsin.

15. No Medical Advice

The Service is a data management tool. Nothing in the Service constitutes medical advice, clinical guidance, or a recommendation for patient treatment. Clinical decisions remain the sole responsibility of qualified healthcare professionals.

16. Contact

For questions about these Terms, contact us at:

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