Terms of Service

These Terms of Service (“Terms”) govern your access to and use of the Neogeniqs marketing website and, where separately contracted, our agentic AI platform for clinical-trial operations and the electronic Trial Master File (together, the “Services”). By accessing the website or using the Services, you agree to these Terms. If you do not agree, do not use the Services. If you use the Services on behalf of an organization, you represent that you are authorized to bind that organization.

Access to the production Platform and processing of clinical-trial data are provided under a separate written agreement between Neogeniqs and the customer organization (a “Customer Agreement”), which may include an order form, master services agreement, service-level terms, a data-processing addendum, and a business-associate agreement. Where a Customer Agreement exists, it controls in the event of any conflict with these Terms with respect to the Platform. These Terms govern general use of the website and any access provided without a separate agreement.

The Services are intended for business and professional use by clinical-research organizations and their authorized personnel. You agree to provide accurate information, keep your credentials confidential, and are responsible for activity under your account. You must promptly notify us of any unauthorized use.

Access to the Platform may be provisioned and administered by your organization, which is responsible for managing its users' access rights and permissions.

You agree not to:

• Use the Services in violation of applicable law, regulation, or Good Clinical Practice, or in a way that infringes the rights of others.
• Attempt to gain unauthorized access to, interfere with, or disrupt the Services, or probe or test their vulnerability without authorization.
• Reverse engineer, decompile, or attempt to derive the source code or underlying models of the Services except to the extent permitted by law.
• Upload malicious code, or submit content you are not authorized to process, or use the Services to develop a competing product.
• Rely on AI-generated output as final without appropriate human review, verification, and approval as described below.

The Platform uses AI agents to assist with clinical-trial tasks such as form design, data extraction, dataset and document generation, and narrative drafting. These outputs are decision-support and drafting aids. They are grounded in your source materials through retrieval-augmented generation, but they may contain errors or omissions and must be reviewed, verified, and approved by qualified personnel before being relied upon or submitted to any regulatory authority.

Neogeniqs does not provide medical, clinical, legal, or regulatory advice, and the Services are not a substitute for the professional judgment of your data managers, biostatisticians, medical writers, regulatory and quality personnel, investigators, or sponsors. You remain responsible for the accuracy, completeness, and regulatory compliance of the work product you generate using the Services.

As between the parties, you (or your organization) retain all rights in the content, documents, and data you submit to the Services (“Customer Content”). You grant Neogeniqs the limited rights necessary to host, process, and deliver the Services on your instructions, and to provide support and security. Our handling of personal data and PHI is described in our Privacy Policy and, where applicable, the data-processing terms in your Customer Agreement. You are responsible for having the rights and legal basis to submit Customer Content for processing.

The Services, including the platform software, AI models, user interfaces, documentation, and all related intellectual property, are owned by Neogeniqs and its licensors and are protected by law. Except for the limited rights expressly granted to you, no rights are transferred. “Neogeniqs” and related marks are our trademarks; you may not use them without our prior written permission.

The Platform is designed to support regulated use, including 21 CFR Part 11 electronic records and signatures, ICH E6(R3) Good Clinical Practice expectations, CDISC standards, and computerized-system validation aligned to GAMP 5. You are responsible for validating the Services for your intended use within your own quality system, maintaining your standard operating procedures, and ensuring your use meets your regulatory obligations. Details are available on our Compliance page.

Neogeniqs is a pre-launch platform, and certain features may be offered as pilot, beta, or pre-release. Such features are provided “as is,” may change or be discontinued, and may not be suitable for production or regulatory-submission use unless expressly agreed. Performance figures presented on our website are pre-launch targets based on internal benchmarks and are not guarantees of results.

The Services may interoperate with third-party systems and providers, such as electronic data capture, RTSM/IWRS, email, validation tooling, and AI model providers. Your use of third-party services is subject to their own terms, and we are not responsible for third-party services we do not control.

Except as expressly stated in a Customer Agreement, the Services are provided “as is” and “as available” without warranties of any kind, whether express, implied, or statutory, including implied warranties of merchantability, fitness for a particular purpose, and non-infringement. We do not warrant that the Services will be uninterrupted, error-free, or that AI-generated output will be accurate or complete.

To the maximum extent permitted by law, and except as otherwise set out in a Customer Agreement, Neogeniqs and its affiliates will not be liable for any indirect, incidental, special, consequential, or punitive damages, or for lost profits, revenues, data, or goodwill, arising out of or relating to your use of the Services. Our aggregate liability for claims relating to the website (absent a Customer Agreement) is limited to one hundred U.S. dollars (US$100). Some jurisdictions do not allow certain limitations, so some of the above may not apply to you.

You agree to indemnify and hold harmless Neogeniqs and its affiliates from claims, damages, liabilities, and expenses arising from your misuse of the Services, your violation of these Terms or applicable law, or your Customer Content, except to the extent caused by Neogeniqs. Any indemnification obligations specific to the Platform are governed by the applicable Customer Agreement.

We may suspend or terminate your access to the website or Services if you violate these Terms or to protect the Services and other users. You may stop using the Services at any time. Termination of Platform access is governed by the applicable Customer Agreement. Provisions that by their nature should survive termination will survive.

These Terms are governed by the laws applicable to Neogeniqs as set out in the applicable Customer Agreement or, absent one, the laws of the United States and the State of Delaware, without regard to conflict-of-law rules. We may update these Terms from time to time; when we make material changes we will update the “last updated” date above, and your continued use constitutes acceptance of the revised Terms.

Questions about these Terms can be sent to legal@neogeniqs.clinic or through our contact page.