Terms of Service

1. Who we are

Clinical Precedent (“the service”) is operated by Elite Tech Media LLC (“the Company”, “we”), a limited liability company. Clinical Precedent™ is a registered Illinois assumed name of Elite Tech Media LLC; charges for subscriptions will appear from Clinical Precedent. You can reach us at support@clinicalprecedent.com.

2. What the service is

Clinical Precedent is a professional research tool for the clinical-research industry. It assembles publicly available U.S. FDA Bioresearch Monitoring records — inspection classifications, cited findings, warning letters, and clinical investigator status lists — into searchable checks, comparisons, reports, and monitoring tools. Access to the full service requires an account and an active subscription — your own, or your organization’s — or complimentary access we have granted. The service is delivered digitally, and access to the full service begins upon payment or, for invoiced plans, when the invoice is issued.

Clinical Precedent is an independent product. It is not affiliated with, endorsed by or connected to the U.S. Food and Drug Administration.

3. Who may use it

The service is offered for business and professional use. You must be at least 18 years old and able to form a binding contract. If you use the service on behalf of an organization, you represent that you are authorized to bind that organization, and “you” includes it.

The service is sold in, and may be used from, the United States and its territories, Canada, the United Kingdom, the European Union and the European Economic Area, Switzerland, Japan, Israel, Australia, New Zealand, South Korea, Singapore and Taiwan. We may refuse a purchase or a sign-in from anywhere else. An organization with a subscription may ask us to admit named people who work for it outside those places, and using the service from outside them without our agreement is a breach of these terms.

4. Accounts

You are responsible for the accuracy of your account information, for keeping your credentials confidential, and for all activity under your account. Notify us promptly at the address above if you believe your account has been compromised. Accounts are for a single named user unless your plan says otherwise; sharing one login across a team is not permitted.

Team and Organization plans. A Team plan covers a stated number of seats, each for one named user, within one organization. The purchaser administers the seats and may reassign a seat to another named user at any time; a seat is for one person at a time, not a pool shared in turns. Organization plans are provided under a separate written agreement, which prevails over these terms where the two differ.

5. Subscriptions, billing, and cancellation

• Billing. Subscriptions are billed in advance on a recurring basis (monthly or annually, as selected at checkout) and renew automatically until cancelled. Payment is processed by Stripe; we do not store your card details.
• Cancellation. You may cancel at any time from your account’s subscription management page or by emailing us. Cancellation takes effect at the end of the current billing period, and you keep access until then; the change may take up to 12 hours to reflect in an open session.
• Invoiced plans. Where we agree to invoice you, invoices are due 30 days from the invoice date unless your order says otherwise. Access may be suspended for invoices that remain unpaid after the due date.
• Promotional pricing. A promotional or founding rate applies for the period stated when it is offered and then reverts to the then-current list price; it is personal to the account it was offered to and may not be transferred.
• Refunds. Except where required by law, fees are non-refundable and we do not provide refunds or credits for partial billing periods, unused time, or downgrades.
• Price changes. We may change subscription prices with at least 30 days’ notice; changes apply from your next renewal, and you may cancel before they take effect.
• Taxes. Prices exclude applicable taxes, which are added at checkout where required.

6. Acceptable use

You agree not to:

• scrape, crawl, bulk-download, or systematically extract data from the service, or use robots or automated scripts against it, except through API or MCP access we provide to you under a separate written agreement;
• resell, redistribute, sublicense, or make the service or substantial portions of its data available to third parties, or use it to build or train a competing product or dataset;
• give a client or other third party access to the service, deliver the service’s reports or data to third parties in volume as a substitute for their own subscription, or offer vetting, screening, monitoring or reporting built on the service as a product of your own. A consultant, CRO or other service provider may use its own subscription in the work it performs for clients, and your own organization’s quality files and regulatory submissions may always incorporate reports about matters they concern; a written service-provider agreement with us (contact support@clinicalprecedent.com) covers anything beyond that;
• share credentials, circumvent authentication, probe, or otherwise interfere with the service’s security or operation;
• use the service for any unlawful purpose, or for any purpose prohibited by section 8 below.

Reasonable use of exports we provide (such as printable reports) inside your own organization’s quality and site-selection work, or in the work a service provider performs for its clients as the list above allows, is exactly what the service is for and is permitted.

Access is metered. We count how much each account reads — records opened, names checked, searches, documents downloaded, and questions asked of the assistants — and apply usage limits. The limits are set with normal professional use in mind; if you reach one and your work is legitimate, email support@clinicalprecedent.com and we will sort it out with you. We may suspend or terminate an account we determine is extracting data in bulk or by automated means, other than through API or MCP access we have agreed in writing to provide, without refund.

What we record about your use, and what we never do. For each account we keep a count of which pages and tools were used and on which days, and how much was read. These are counts only: we do not keep a record of what you searched for, or of which clinical investigators, sites or documents you looked at. We use the counts to operate and protect the service, to support you, to improve the product and to manage subscriptions; we do not sell them or share them with anyone outside the providers that run the service (see our Privacy Policy).

7. The data — what it is and what it is not

The service reports information derived from publicly available FDA records. Those records are historical, incomplete by nature, and may contain errors, omissions, or out-of-date information originating with the source; we do not and cannot guarantee their accuracy or completeness. In particular:

• The absence of a record in the service is not evidence that no FDA activity exists — it means no matching record appears in the publicly available data we hold.
• Some FDA lists are published with names only. Matches against those lists are made by name and are labeled “name match”; a name match is not confirmation of identity, and identity must be verified before relying on it.
• Deficiency-area tags and similar groupings are our own classification of the record, made with automated assistance; they are not FDA’s and may be imperfect.
• The optional AI assistants generate their answers automatically, from the record or document on the page or from our guides. An answer may be incomplete or wrong, is not a substitute for reading the record, document or guide itself, and is not legal, regulatory, or medical advice.
• The service reports the record. It does not score, rank, or make recommendations, and nothing in it is legal, regulatory, or medical advice. Decisions you make — including site selection, engagement, and submission decisions — are yours, and you are responsible for independently verifying any information you rely on.

8. Not a consumer reporting agency

Clinical Precedent is not a consumer reporting agency as defined by the Fair Credit Reporting Act (FCRA), and the service does not constitute a “consumer report”. You may not use the service or its data, in whole or in part, to determine any individual’s eligibility for employment, credit, insurance, housing, or any other purpose covered by the FCRA, or for any other consumer-purpose evaluation of an individual. The service is provided solely for business-to-business professional due diligence on the regulatory history of clinical-research parties such as clinical investigators, sponsors, CROs, and IRBs.

9. Intellectual property

The service — its software, design, organization, compilations, classifications, and documentation — is owned by the Company and protected by law. We grant you a limited, non-exclusive, non-transferable right to use the service for your internal business purposes — which include, for a consultant, CRO or other service provider, the work it performs for its clients as section 6 allows — while your account is in good standing. Underlying U.S. government records are public information; the service’s selection, arrangement, enrichment, and presentation of them are ours. If you send us feedback, we may use it without obligation.

10. Third-party services

We use reputable third-party providers to operate the service — including Clerk (authentication), Stripe (payments), Neon (data storage), Vercel (hosting), Resend (email), Cloudflare (video delivery) and Anthropic (the AI provider behind the optional assistants). Their processing of your information is described in our Privacy Policy.

11. Disclaimer of warranties

THE SERVICE IS PROVIDED “AS IS” AND “AS AVAILABLE”, WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, AND NON-INFRINGEMENT. WE DO NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED, ERROR-FREE, OR THAT ITS DATA IS COMPLETE, CURRENT, OR ACCURATE.

12. Limitation of liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, THE COMPANY WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR ANY LOSS OF PROFITS, REVENUE, DATA, OR BUSINESS OPPORTUNITY, ARISING FROM OR RELATED TO THE SERVICE, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY. TO THE SAME EXTENT, OUR TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS RELATING TO THE SERVICE IS LIMITED TO THE AMOUNTS YOU PAID US FOR THE SERVICE IN THE TWELVE MONTHS BEFORE THE EVENT GIVING RISE TO THE CLAIM (OR $100 IF YOU HAVE PAID NOTHING). Some jurisdictions do not allow certain limitations, so parts of this section may not apply to you.

13. Indemnification

You will defend and hold the Company harmless from claims arising out of your misuse of the service, your violation of these terms (including sections 6 and 8), or decisions you make in reliance on the service.

14. Suspension and termination

You may stop using the service at any time and ask us to delete your account at privacy@clinicalprecedent.com. We may suspend or terminate access for breach of these terms (including non-payment), for unlawful use, or to protect the service or its data, with notice where practicable. Termination for automated or bulk extraction under section 6 is without refund of fees already paid. Sections 7–9 and 11–16 survive termination.

15. Changes to the service and to these terms

The service evolves; features may be added, changed, or removed. We may update these terms from time to time. For material changes we will give notice (for example by email or an in-service notice) before they take effect; continued use after that date constitutes acceptance. The current version is always at this page.

16. Governing law and disputes

These terms are governed by the laws of the State of Illinois, without regard to its conflict-of-laws rules. Courts located in Illinois have exclusive jurisdiction over disputes arising from these terms or the service, and each party consents to their jurisdiction. If any provision of these terms is found unenforceable, the remainder stays in effect. These terms are the entire agreement between you and the Company regarding the service, except any separate written agreement we sign with you; our Privacy Policy describes how we handle information.

17. Contact

Elite Tech Media LLC · support@clinicalprecedent.com