Terms of Service

By accessing or using Orbitech Global LLC (“Orbitrials,” “the Platform,” “we,” “us,” or “our”), you agree to be bound by these Terms of Service (“Terms”). If you are using Orbitrials on behalf of an organization, you represent that you have authority to bind that organization to these Terms.

If you do not agree to these Terms, you must not access or use the Platform.

Orbitrials is a cloud-based clinical trial management platform designed to assist sponsors, clinical research sites, and their personnel in managing clinical research operations, including protocol management, participant enrollment, electronic data capture (eCRF), delegation logs, adverse event reporting, and regulatory compliance documentation.

Orbitrials is designed to support compliance with 21 CFR Part 11 (Electronic Records; Electronic Signatures), HIPAA Security Rule (45 CFR Part 164), and Good Clinical Practice (GCP) guidelines. However, you remain solely responsible for ensuring your use of the Platform meets all applicable regulatory requirements for your specific context.

You must provide accurate, complete, and current information when registering for an account. You are responsible for maintaining the confidentiality of your login credentials and for all activities that occur under your account.

Multi-factor authentication (MFA) is required for all Principal Investigator, Sponsor Admin, and System Administrator accounts. You must not share your credentials with any other person. Shared logins are strictly prohibited and constitute a violation of 21 CFR Part 11 requirements.

You must notify us immediately at security@orbitrials.com if you suspect any unauthorized access to your account.

You agree to use Orbitrials only for lawful purposes and in accordance with these Terms. You agree not to:

• Use the Platform in any way that violates applicable federal, state, or local law
• Enter false, misleading, or fraudulent data into the Platform
• Attempt to circumvent any audit trail, electronic signature, or access control mechanism
• Access, tamper with, or use non-public areas of the Platform or its infrastructure
• Reverse engineer, decompile, or disassemble any portion of the Platform
• Use the Platform to store or transmit malicious code
• Impersonate or misrepresent your affiliation with any person or organization

Orbitrials may process Protected Health Information (PHI) as defined under the Health Insurance Portability and Accountability Act (HIPAA). By using the Platform to process PHI, you confirm that a valid Business Associate Agreement (BAA) has been executed between your organization and Orbitech Global LLC.

You are responsible for ensuring that all PHI entered into the Platform is handled in accordance with HIPAA requirements, your organization's privacy policies, and applicable IRB protocols. You must obtain valid informed consent from research participants before entering their data.

OrbiTrials offers the following subscription plans billed monthly: Site Starter ($499/mo) for single research sites, Site Network ($999/mo) for multi-site SMOs, and Sponsor Track ($2,500/mo) for sponsors and CROs. Add-on seats and features are available separately. All fees are non-refundable except as required by law or as expressly stated herein.

Trial accounts may be provided at no charge for a limited period. At the end of the trial, you must subscribe to a paid plan to continue using the Platform.

We reserve the right to change pricing upon 30 days' written notice. Continued use after the notice period constitutes acceptance of the new pricing.

We may suspend or terminate your account for non-payment. If your subscription lapses, your data will be retained for 90 days before permanent deletion.

You retain full ownership of all data you input into the Platform, including clinical trial data, participant records, and organizational information. We claim no ownership of your data.

Upon request at any time during your subscription, or during the 90-day retention window following cancellation or termination (see Section 12), we will provide an export of your data in a standard machine-readable format (CSV, JSON, or CDISC ODM XML) within 30 days of the request.

Orbitrials provides tools designed to assist with regulatory compliance but does not guarantee regulatory approval or compliance outcomes. You are solely responsible for:

• Validating the Platform for your specific intended use (IQ/OQ/PQ)
• Maintaining your own validation documentation
• Ensuring your use complies with all applicable regulations (FDA, ICH, local law)
• Training your personnel on proper use of the Platform
• Any regulatory submissions or interactions with health authorities

The Platform and its original content, features, and functionality are owned by Orbitrials Clinical Solutions and are protected by copyright, trademark, and other intellectual property laws. You are granted a limited, non-exclusive, non-transferable license to use the Platform solely for your internal business purposes.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, ORBITRIALS CLINICAL SOLUTIONS SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING LOSS OF PROFITS, DATA, USE, GOODWILL, OR OTHER INTANGIBLE LOSSES.

OUR TOTAL LIABILITY TO YOU FOR ALL CLAIMS ARISING OUT OF OR RELATING TO THESE TERMS OR THE PLATFORM SHALL NOT EXCEED THE AMOUNT YOU PAID US IN THE 12 MONTHS PRECEDING THE CLAIM.

You agree to indemnify, defend, and hold harmless Orbitech Global LLC and its officers, directors, employees, and agents from and against any claims, liabilities, damages, judgments, awards, losses, costs, or expenses arising out of your use of the Platform, your violation of these Terms, or your violation of any applicable law or regulation.

You may cancel your subscription at any time from your billing portal or by written notice to info@orbitrials.com. Cancellation takes effect at the end of your current billing period; no further charges accrue after that date. We may suspend or terminate your access immediately for violation of these Terms, non-payment, or if required by law.

What happens to your data when you cancel:

• Days 1–90 after cancellation: your data is retained in read-only form. You may request a complete export at any time during this window, and we will deliver it within 30 days in a standard machine-readable format (CSV, JSON, or CDISC ODM XML) at no additional charge, consistent with Section 7.
• After 90 days: your data is permanently and irreversibly deleted from our production systems, and it ages out of our encrypted backups within 35 days thereafter. Deleted data cannot be recovered.
• Protected Health Information: PHI is returned or destroyed in accordance with the termination provisions of your executed Business Associate Agreement, which control over this section in the event of any conflict.
• Audit trails and signature records are included in your export so your 21 CFR Part 11 documentation remains complete and inspection-ready.

Your regulatory retention obligations survive cancellation. Sponsors and investigators remain solely responsible for retaining clinical trial records for the periods required by applicable law (e.g., 21 CFR 312.62, ICH GCP E6). You must export your records before the 90-day deletion deadline; deletion by us does not relieve you of those obligations.

Upon termination, your right to use the Platform ceases immediately. Sections 5, 7, 9, 10, 11, and 13 survive termination.

These Terms are governed by the laws of the United States and the State of Florida, without regard to conflict of law principles. Any dispute arising under these Terms shall be resolved by binding arbitration under the rules of the American Arbitration Association, except that either party may seek injunctive relief in any court of competent jurisdiction.

We reserve the right to modify these Terms at any time. We will provide at least 14 days' notice of material changes by email or in-app notification. Your continued use after the effective date constitutes acceptance of the revised Terms.

For questions about these Terms, contact us at:
Orbitech Global LLC
legal@orbitrials.com