Disclaimer

Planning Support Only — Not Regulatory, Legal, or Medical Advice

TrialCraft provides design suggestions and internal planning support only. It does not provide legal advice, medical advice, or regulatory approval advice, and does not perform formal regulatory review on behalf of sponsors or regulatory agencies. All design options, sample size suggestions, and analysis plans are provided as planning inputs to support your team's own decision-making process.

No Liability for Regulatory Outcomes

TrialCraft does not guarantee any specific regulatory outcome, including but not limited to FDA approval, IND acceptance, or favorable review. The sponsor (client) retains full responsibility for all regulatory submissions, clinical decisions, and trial conduct. TrialCraft outputs are suggestions informed by FDA guidance, not regulatory determinations.

Not a Substitute for Professional Judgment

The information and suggestions provided by TrialCraft, including AI-generated outputs, are intended to supplement — not replace — the professional judgment of the sponsor's clinical, regulatory, and statistical teams. Clients should independently verify all suggestions before acting on them.

AI-Generated Content

TrialCraft uses artificial intelligence to generate trial design suggestions, endpoint strategies, and statistical planning inputs. While we strive for accuracy, AI-generated content may contain errors or omissions. All AI outputs should be reviewed by qualified professionals before use in any regulatory or clinical context. AI suggestions are informed by FDA guidance but do not represent FDA positions or determinations.

No Patient Data

TrialCraft is designed for study-level planning inputs (e.g., study briefs, design summaries). It is not designed to process, store, or manage patient-level data, protected health information (PHI), or individually identifiable health data. Users should not submit PHI through the platform. TrialCraft is not a HIPAA-covered service.

Confidentiality

TrialCraft treats all client information, including compound details, study designs, and program strategies, as strictly confidential. We do not share, sell, or disclose client data to any third party. See our Privacy Policy for details.

Limitation of Liability

To the maximum extent permitted by law, TrialCraft and its consultants shall not be liable for any direct, indirect, incidental, consequential, or special damages arising from the use of our services, including but not limited to:

• Regulatory delays or rejections
• Clinical trial failures or adverse events
• Financial losses related to drug development decisions
• Errors or omissions in AI-generated recommendations

Intellectual Property

Deliverables produced by TrialCraft for a client belong to the client upon full payment. TrialCraft retains the right to use anonymized, aggregated insights from its work to improve its AI platform and services.

Last updated: April 2026. This disclaimer is subject to change. Clients will be governed by the terms in their individual Master Services Agreement (MSA).