Working draft — not yet reviewed by an attorney. This is meaningfully more complete than a placeholder, but should not be treated as a final or binding contract until reviewed by counsel, especially the sections marked below (liability, termination, and governing law).

Terms of Service

OPIA Clinical LLC · Draft prepared September 25, 2026

By creating an account or using the OPIA coordinator workspace ("Platform"), a site and its authorized users agree to these terms. If a site has a separate signed Order Form or Service Agreement with OPIA, that document's specific terms (pricing, term, cancellation) govern where it conflicts with this general page.

Description of service

OPIA is an electronic source data capture (eSource) and monitoring tool for ophthalmology clinical trials. It is intended for use solely to capture, review, and manage clinical trial visit data for enrolled subjects, per the site's own study protocol.

Not a medical device

OPIA is a data capture and alerting tool. It does not diagnose, treat, or make autonomous clinical decisions, and it is not a substitute for clinical judgment. All treatment decisions remain the sole responsibility of the site's qualified investigators.

Accounts and site responsibilities

Data ownership and OPIA's role

Data entered by a site remains that site's data. OPIA acts as a data processor of that data on the site's behalf and does not use it for any purpose other than operating the Platform for that site, as described in our Privacy Policy.

TODO (legal): where a site is a HIPAA covered entity, this relationship should be formalized with a signed Business Associate Agreement (BAA) in addition to these terms.

Fees and payment

Fee-bearing sites are billed according to the pricing and terms in their signed Order Form. Sites participating in a pilot are governed by the Pilot status section below instead.

Pilot status

During an explicitly designated pilot period, OPIA is provided as-is, at no cost, and either party may end the pilot at any time in writing. Pilot terms do not automatically convert to a paid subscription — a site moves to paid status only after signing an Order Form.

Term and cancellation

For paid sites, this Agreement is month-to-month. Either party may cancel with 30 days' written notice (email is sufficient). Upon cancellation, OPIA will make the site's data available for export for a defined period before deletion.

TODO (business decision): confirm the exact post-cancellation data export window (e.g. 90 days) and keep it consistent with the Privacy Policy and Order Form.

Disclaimer of warranties

The Platform is provided "as is." OPIA does not warrant that the Platform will be uninterrupted or error-free, and disclaims implied warranties of merchantability or fitness for a particular purpose to the maximum extent permitted by law.

TODO (legal): standard disclaimer language above should be reviewed and likely expanded/tightened by counsel to fit California law and OPIA's actual risk tolerance.

Limitation of liability

To the maximum extent permitted by law, OPIA's total liability arising out of or related to use of the Platform will not exceed the fees paid by the site in the twelve months preceding the claim.

TODO (legal): this is a standard SaaS liability cap, but the specific number, carve-outs (e.g. for gross negligence or data breach), and enforceability should be confirmed by counsel — this is one of the most important clauses to get right for a healthcare-adjacent product.

Compliance posture

OPIA maintains a server-side audit trail, role-based access controls, and support for electronic signatures on key clinical records, consistent with common expectations for electronic source systems in clinical research. This is a description of current functionality, not a certification of compliance with any specific regulation (e.g. 21 CFR Part 11) — sites should evaluate the Platform against their own protocol and regulatory requirements before relying on it as their system of record.

Governing law

These terms are governed by the laws of the State of California.

TODO (legal): confirm governing law and whether to add a dispute resolution clause (arbitration vs. courts, venue).

Changes to these terms

We'll update the "last updated" date below when these terms change, and will notify site administrators of material changes.

Contact

Contact: support@opiaclinical.com

Last updated: working draft, September 25, 2026 — pending attorney review, and pending a signed Business Associate Agreement per site, before use with real subject data.