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 workflows built to 21 CFR Part 11.
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(R3) 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 tamper-evident audit trail for 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