The agreement governing your use of TrialScope — written in plain language because we think clinical research professionals deserve clarity, not legalese.
TrialScope is an AI-powered clinical evidence review platform operated by Big Head Consulting LLC (pending transfer to TrialScope, Inc. upon incorporation), an Illinois limited liability company. The platform generates structured audits of clinical research documents — Clinical Study Reports, protocols, statistical analysis plans, investigator brochures, manuscripts, regulatory submissions, and similar documents — calibrated to your professional role.
TrialScope is not: a regulatory submission tool, a substitute for review by a qualified human expert, a medical device, a diagnostic tool, or HIPAA-compliant infrastructure. See the AI Disclosure for what the platform's AI can and cannot do.
To use TrialScope, you must be at least 18 years old, authorized to bind any entity on whose behalf you use the platform, and not barred from receiving services under applicable law. You agree to provide accurate information when creating an account, including accurate representation of your professional persona.
You are responsible for maintaining the confidentiality of your account credentials and for all activity that occurs under your account. If you suspect unauthorized access, notify us immediately at robert@trialscope.ai.
You own your content. Submitting content to TrialScope does not transfer ownership to us. You retain all rights you had before submission.
License you grant us. By submitting content, you grant TrialScope a limited, non-exclusive, royalty-free license to process the content to generate audit output for you, store the audit output in your account history, and — only if you opt in via the per-contribution consent scope — use de-identified aggregations of corrections and feedback to improve audit quality for all users.
What you represent. You represent that you have the right to submit any content you submit, that your content does not contain Protected Health Information or other identifiable personal data of third parties, that your content does not infringe any third party's rights, and that your submission complies with all applicable confidentiality obligations you may have to sponsors, employers, or clients.
You are the gatekeeper for what you submit. We do not pre-screen content. You are responsible for the consequences of submitting content that violates these representations.
TrialScope is not configured as a HIPAA Business Associate.
Do not submit clinical documents that contain identifiable patient data — including names, dates of birth, medical record numbers, photographs, or other direct identifiers. The platform is designed for methodology and evidence review using protocols, SAPs, investigator brochures, study reports, manuscripts, and similar planning or reporting documents — not patient data.
If you submit PHI in error, contact us immediately at robert@trialscope.ai. We do not store input document content beyond active processing, but treat any such submission as a potential incident under your organization's data handling policies.
TrialScope uses a foundation AI model (Anthropic's Claude) to generate audit output. AI-generated output may contain errors, omissions, or misinterpretations. It should be reviewed by a qualified human before being used for any consequential purpose.
We make no representation that audit output is accurate, complete, current, or suitable for any particular purpose. The persona-calibration features improve output quality over time but do not eliminate the need for human review. Treat the output as a sophisticated first pass, not a final product.
You are responsible for any actions you take or decisions you make based on audit output. We are not responsible for regulatory, publication, investment, clinical, or other consequences arising from your reliance on audit output. See the for detailed framing on AI capabilities and limits.
You agree not to use TrialScope to:
We reserve the right to suspend or terminate accounts that violate these acceptable use rules.
TrialScope is currently free to use. Audits consume credits, and accounts receive complimentary credits at no charge while the platform is free. We are not charging for the service at this time and there is no payment rail active. If we introduce paid plans in the future, prices and terms will be stated on the pricing page before any charge, you will be notified in advance, and an attorney-reviewed version of these Terms will be published first.
Because the platform is currently free, there are no charges, purchases, or refunds at this time. Should paid plans be introduced later, refund and pricing-change terms will be published with them in advance.
Our IP. The TrialScope platform — including all software, branding, design, documentation, prompts, AI calibration data, controlled vocabularies, and aggregated insights — is our intellectual property and is protected by copyright and other laws. You may not copy, modify, distribute, or create derivative works of the platform.
Your audit output. Subject to your compliance with these Terms, you may use audit output for your own professional purposes, including incorporating findings into your own work product. You may not republish audit output as if it were your own analysis without appropriate attribution to TrialScope as a tool used in its production.
Feedback. If you provide us feedback, suggestions, or ideas about the platform, we may use that feedback freely without obligation to you.
You may stop using TrialScope at any time. You may delete your account through your settings or by emailing robert@trialscope.ai.
We may suspend or terminate your access if you violate these Terms, if your use poses a security or operational risk, or for any other reason on reasonable notice. On termination, your access ends and your account data is deleted per the Privacy Policy retention schedule, subject to legal retention requirements. Sections that should reasonably survive termination (IP, disclaimers, limitations of liability, indemnification, dispute resolution) survive.
THE PLATFORM IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND. WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, AND ACCURACY.
TO THE MAXIMUM EXTENT PERMITTED BY LAW, WE ARE NOT LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES. OUR TOTAL LIABILITY FOR ALL CLAIMS ARISING FROM OR RELATED TO YOUR USE OF THE PLATFORM IS LIMITED TO THE GREATER OF (A) $100 OR (B) THE AMOUNT YOU PAID US IN THE 12 MONTHS PRECEDING THE EVENT GIVING RISE TO THE CLAIM.
Some jurisdictions do not allow exclusion of certain warranties or limitations on certain damages. Those limitations apply to the maximum extent permitted by law.
You agree to indemnify and hold harmless TrialScope, its officers, members, employees, and contractors from any claim, loss, liability, or expense (including reasonable attorneys' fees) arising from your use of the platform in violation of these Terms or applicable law, your submission of content (including any claim that the content infringes third-party rights or contains PHI), your reliance on audit output for any professional or regulatory purpose, or your violation of any third-party rights including confidentiality obligations to sponsors, employers, or clients.
These Terms are governed by the laws of the State of Illinois, without regard to conflict of laws principles.
Any dispute arising from these Terms or your use of the platform will be resolved first by good-faith negotiation (notify us at robert@trialscope.ai), and if negotiation fails, by binding arbitration in DuPage County, Illinois, per the rules of the American Arbitration Association. You and TrialScope each waive any right to participate in a class action lawsuit, class-wide arbitration, or other representative proceeding. You may opt out of arbitration by notifying us in writing within 30 days of accepting these Terms.
We may update these Terms as the platform evolves. Material changes will be communicated to registered users by email at least 14 days before they take effect. The "Last updated" date at the top of this page reflects the most recent revision. Continued use of the platform after notice of changes constitutes acceptance.
Questions about these Terms, the platform, or anything in between: robert@trialscope.ai.