Terms of Service

1. Nature of Service

TrialCraft is an AI-powered trial design planning tool that provides structured design suggestions informed by FDA guidance. It is intended to support your team's internal planning process. TrialCraft does not provide legal advice, medical advice, regulatory approval advice, or formal regulatory review. All outputs are suggestions, not determinations.

2. Acceptable Use

You agree to use TrialCraft only for lawful purposes related to clinical trial design planning. You may not:

• Submit patient-level data, protected health information (PHI), or individually identifiable health data
• Submit data you do not have authorization to share
• Rely on TrialCraft outputs as a substitute for professional biostatistical, clinical, regulatory, or legal judgment
• Represent TrialCraft outputs as formal regulatory review, FDA positions, or regulatory determinations
• Use TrialCraft to generate content intended to deceive regulatory agencies
• Attempt to reverse-engineer, extract, or replicate the TrialCraft AI system or knowledge base

3. No PHI or Patient Data

TrialCraft is designed for study-level planning inputs such as study briefs and design summaries. It is not designed to process, store, or manage protected health information (PHI), patient-level data, or individually identifiable health data. Do not submit PHI through the platform. TrialCraft is not a HIPAA-covered service and does not maintain a Business Associate Agreement (BAA).

4. AI-Generated Outputs

All design suggestions, assumption checks, and planning inputs generated by TrialCraft are produced by artificial intelligence and may contain errors, omissions, or inaccuracies. You are responsible for independently verifying all outputs before relying on them for any purpose. TrialCraft outputs are informed by FDA guidance documents but do not represent the views, positions, or determinations of the FDA or any regulatory authority.

5. Data Handling

Study planning inputs you submit are processed in real-time to generate suggestions and are not permanently stored. For full details on how we handle your data, see our Privacy Policy. We do not use your proprietary inputs to train AI models.

6. Intellectual Property

The TrialCraft platform, including its AI models, knowledge base, user interface, and documentation, is the intellectual property of Insight Mind AI LLC. You may not copy, distribute, or create derivative works from TrialCraft without written permission. Outputs generated for you based on your inputs belong to you, subject to these Terms.

7. Limitation of Liability

To the maximum extent permitted by law, TrialCraft and Insight Mind AI LLC shall not be liable for any direct, indirect, incidental, consequential, or special damages arising from your use of the service, including but not limited to:

• Regulatory delays, rejections, or adverse outcomes
• Clinical trial failures or adverse events
• Financial losses related to drug development decisions
• Errors or omissions in AI-generated suggestions
• Decisions made based on TrialCraft outputs

8. Disclaimer of Warranties

TrialCraft is provided "as is" without warranties of any kind, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, accuracy, or non-infringement. We do not warrant that the service will be uninterrupted, error-free, or that outputs will be accurate or complete.

9. Indemnification

You agree to indemnify and hold harmless TrialCraft, Insight Mind AI LLC, and their officers, directors, employees, and agents from any claims, damages, or expenses arising from your use of the service, your violation of these Terms, or your submission of data you were not authorized to share.

10. Modifications

We may update these Terms from time to time. Continued use of TrialCraft after changes are posted constitutes acceptance of the updated Terms. For consulting engagements, individual Master Services Agreements (MSAs) will govern.

11. Governing Law

These Terms are governed by the laws of the State of California, United States, without regard to conflict of law principles.

12. Contact

If you have questions about these Terms, contact us at:
TrialCraft / Insight Mind AI LLC
support@insightmind.tech

Last updated: April 2026.