Terms of Service
Effective date: 1 January 2026
These Terms of Service ("Terms") govern your access to and use of Clinivion LLC's ("Clinivion") services, including the Nessa platform and clinivion.com. By accessing our services, you agree to these Terms.
1. Services
Clinivion provides pharmaceutical data integrity software, including the Nessa platform for FDA 21 CFR Part 11 compliance, ALCOA+ validation, and cryptographic audit trail generation. Our services are intended for use by qualified pharmaceutical, biotech, and clinical research organisations.
2. Accounts & Access
You are responsible for maintaining the confidentiality of your account credentials. You must notify us immediately of any unauthorised access. Accounts may not be shared between individuals. Access is granted per the licence agreement signed at onboarding.
3. Acceptable Use
You agree not to:
- Use the platform in a manner that violates applicable GxP, FDA, EMA, or ICH regulations
- Attempt to circumvent cryptographic audit controls or tamper with audit trail data
- Reverse engineer, decompile, or disassemble any part of the Nessa platform
- Use the services for any unlawful purpose or to process data you are not authorised to handle
4. Data Ownership
You retain ownership of all clinical data you submit to the Nessa platform. Clinivion acts as a data processor on your behalf. We do not access your data except as necessary to provide the service or as required by law.
5. Validation & Regulatory Responsibility
Nessa is designed to support your validation efforts under applicable regulations. Clinivion provides validation documentation (IQ/OQ/PQ protocols, validation reports). However, the customer remains responsible for completing system validation in their own environment and for regulatory submissions.
6. Uptime & SLA
We target 99.9% uptime for the Nessa platform, excluding scheduled maintenance windows communicated with at least 48 hours notice. SLA credits for downtime events are defined in your service agreement.
7. Limitation of Liability
To the maximum extent permitted by law, Clinivion's liability for any claim arising from use of the services is limited to the fees paid in the preceding three months. We are not liable for indirect, incidental, or consequential damages.
8. Termination
Either party may terminate the service agreement with 30 days written notice. Upon termination, you may export your data in a machine-readable format for a period of 30 days. After that, data will be securely deleted in accordance with GxP data retention requirements.
9. Governing Law
These Terms are governed by the laws of England and Wales. Any disputes shall be subject to the exclusive jurisdiction of the courts of England and Wales.
10. Contact
Clinivion LLC
edem@clinivion.com