Terms of Service

Effective Date: February 2, 2026

1. Acceptance of Terms

Welcome to Trialsights. These Terms of Service ("Terms") govern your access to and use of the Trialsights platform, including our mobile applications, websites, and related services (collectively, the "Services"), operated by 3rt Labs LLC ("Trialsights," "we," "us," or "our").

By accessing or using our Services, you agree to be bound by these Terms. If you do not agree to these Terms, you may not access or use the Services.

Eligibility: You must be at least 18 years old to use our Services, unless you are a minor participating in a clinical trial with appropriate parental or guardian consent. If you are using the Services on behalf of an organization, you represent that you have authority to bind that organization to these Terms.

2. Description of Services

Trialsights provides a clinical trial compliance and medication adherence platform designed for pharmaceutical research. Our Services include:

Participant Mobile Application

Enables clinical trial participants to log medication doses, submit photo verification, record daily notes, and receive dose reminders. The app includes on-device face detection to protect privacy before photo uploads.

Staff Administration Application

Allows authorized trial staff to monitor participant compliance, manage enrollments, track adherence incidents, create protocol deviation requests, and access compliance analytics.

Website

Provides information about our Services, enables contact with our team, and allows scheduling of product demonstrations.

3. Account Registration & Security

Account Creation

Access to the Trialsights mobile applications requires account credentials provided by your clinical trial site or sponsor. You may not create accounts independently or share your credentials with others.

Authentication

Our applications use multi-factor authentication including passwords, PIN codes, and optional biometric authentication (Face ID/Touch ID). You are responsible for maintaining the confidentiality of your authentication credentials.

Session Security

For your protection, sessions automatically expire after periods of inactivity. You agree not to circumvent these security measures and to log out when using shared devices.

Credential Security

You must immediately notify your trial site coordinator and Trialsights if you suspect unauthorized access to your account or any security breach. You are responsible for all activities that occur under your account.

4. User Responsibilities

For Trial Participants:

  • Log medication doses accurately and honestly, including timing and any missed doses
  • Submit clear, unobstructed photos of medications when required
  • Provide truthful information regarding missed dose reasons
  • Keep your device secure and prevent unauthorized access to the application
  • Report any technical issues that may affect your ability to log doses

For Staff/Administrators:

  • Access only participant data for trials you are authorized to manage
  • Maintain strict confidentiality of all participant information
  • Use electronic signatures only for actions you are authorized to approve
  • Comply with all applicable clinical trial protocols and regulations
  • Report any data discrepancies or compliance concerns to appropriate parties

5. Data Collection & Privacy

Your privacy is important to us. Our collection, use, and protection of your personal information is governed by our Privacy Policy, which is incorporated into these Terms by reference.

Protected Health Information (PHI): The Services may collect and process health-related data in connection with your participation in clinical trials. This data is handled in accordance with applicable healthcare privacy regulations, including HIPAA where applicable.

California Residents: For information about your rights under the California Consumer Privacy Act (CCPA), please see our Do Not Sell or Share My Personal Information page.

6. Electronic Records & Signatures

Trialsights is designed to support compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in regulated clinical trial environments.

Electronic Signatures

Electronic signatures within the Services are legally binding and equivalent to handwritten signatures. Each signature is unique to the individual and cannot be reused or reassigned.

Audit Trails

The Services maintain comprehensive audit trails of all user actions, including timestamps, user identification, and the nature of each action, in accordance with regulatory requirements.

Record Integrity

Electronic records are protected against unauthorized modification. All changes are tracked and attributed to the responsible user.

Record Retention

Electronic records are retained in accordance with applicable clinical trial regulations and sponsor requirements.

7. Intellectual Property

Our Property: The Services, including all software, designs, text, graphics, logos, and other content, are owned by 3rt Labs LLC and protected by intellectual property laws. You may not copy, modify, distribute, sell, or lease any part of our Services without our written permission.

Your Content: You retain ownership of any content you submit through the Services (such as medication photos and notes). By submitting content, you grant us a license to use, store, and share that content as necessary to provide the Services and fulfill clinical trial requirements.

Restrictions: You may not reverse engineer, decompile, or disassemble the Services, or attempt to derive source code from the applications.

8. Acceptable Use Policy

You agree not to:

  • Access accounts or data belonging to other users without authorization
  • Submit false, misleading, or fraudulent information
  • Manipulate, alter, or delete clinical trial data inappropriately
  • Interfere with or disrupt the Services or servers
  • Attempt to bypass security measures or authentication systems
  • Use the Services for any illegal purpose or in violation of any laws
  • Share your credentials or allow others to access your account
  • Use automated systems (bots, scrapers) to access the Services

9. Healthcare Disclaimers

IMPORTANT: Trialsights is a compliance tracking tool, not a medical device or healthcare provider.

Not Medical Advice: The Services do not provide medical advice, diagnosis, or treatment. Always consult your healthcare provider or clinical trial staff for medical questions or concerns.

Clinical Trial Participation: Your participation in any clinical trial is governed by the trial protocol and informed consent documents provided by your trial site, not by these Terms.

Emergency Situations: In case of a medical emergency, contact emergency services (911) or go to your nearest emergency room immediately. Do not rely on the Trialsights application for emergency communications.

No Guarantees: We make no guarantees regarding the outcomes of any clinical trial or the effectiveness of any treatment being studied.

10. Third-Party Services

The Services integrate with third-party services to provide functionality:

Push Notifications

We use Firebase Cloud Messaging (via Expo) to deliver push notifications for dose reminders and alerts.

Face Detection

We use Google ML Kit for on-device face detection to help protect your privacy in medication photos. This processing occurs entirely on your device; no facial data is sent to external servers.

Cloud Infrastructure

Our Services are hosted on secure cloud infrastructure providers that maintain appropriate security certifications.

These third-party services have their own terms and privacy policies. We are not responsible for the practices of third-party service providers.

11. Disclaimers & Limitation of Liability

DISCLAIMER OF WARRANTIES

THE SERVICES ARE PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT.

LIMITATION OF LIABILITY

TO THE MAXIMUM EXTENT PERMITTED BY LAW, 3RT LABS LLC SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR ANY LOSS OF PROFITS OR REVENUES, WHETHER INCURRED DIRECTLY OR INDIRECTLY, OR ANY LOSS OF DATA, USE, GOODWILL, OR OTHER INTANGIBLE LOSSES RESULTING FROM YOUR USE OF THE SERVICES.

Some jurisdictions do not allow the exclusion of certain warranties or limitation of liability, so some of the above limitations may not apply to you.

12. Indemnification

You agree to indemnify, defend, and hold harmless 3rt Labs LLC, its officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, and expenses (including reasonable attorneys' fees) arising out of or in any way connected with: (a) your access to or use of the Services; (b) your violation of these Terms; (c) your violation of any third-party rights, including privacy rights; or (d) any content you submit through the Services.

13. Termination

By You: You may stop using the Services at any time. If you are a trial participant, please consult with your trial site coordinator regarding the proper process for discontinuing use.

By Us: We may suspend or terminate your access to the Services at any time for any reason, including if we reasonably believe you have violated these Terms or if the clinical trial you are participating in concludes.

Effect of Termination: Upon termination, your right to use the Services will immediately cease. Provisions of these Terms that by their nature should survive termination shall survive, including ownership provisions, warranty disclaimers, indemnification, and limitations of liability.

Data Retention: Clinical trial data may be retained as required by applicable regulations and sponsor requirements, even after your access to the Services is terminated.

14. Governing Law & Dispute Resolution

Governing Law: These Terms shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts, United States, without regard to its conflict of law provisions.

Informal Resolution First

Before initiating any formal dispute resolution, you agree to first contact us at [email protected] and attempt to resolve the dispute informally for at least 30 days. Most disputes can be resolved through good-faith discussion.

Binding Arbitration

If informal resolution is unsuccessful, any dispute arising from these Terms or the Services shall be resolved by binding arbitration administered by the American Arbitration Association (AAA) in accordance with its Commercial Arbitration Rules.

The arbitration shall take place in Boston, Massachusetts, unless the parties agree otherwise. The arbitrator's decision shall be final and binding, and judgment may be entered in any court of competent jurisdiction.

Class Action Waiver: You agree that any dispute resolution proceedings will be conducted only on an individual basis and not in a class, consolidated, or representative action.

Small Claims Exception: Notwithstanding the above, either party may bring an individual action in small claims court for disputes within the court's jurisdiction.

15. Changes to Terms

We may modify these Terms from time to time. When we make changes, we will update the "Effective Date" at the top of this page and, for material changes, we will provide additional notice (such as through the Services or via email).

Your continued use of the Services after changes become effective constitutes your acceptance of the revised Terms. If you do not agree to the modified Terms, you should discontinue using the Services.

Contact Us

If you have any questions about these Terms of Service, please contact us.

3rt Labs LLC

Legal: [email protected]

Privacy: [email protected]

General: [email protected]

Last Updated: February 2, 2026