PharmaTrialsCortex Clinical Intelligence
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Terms of Service

Last updated: v2.0

These Terms of Service (“Terms”) constitute a legally binding agreement between you (either an individual or an entity, “you” or “your”) and DataTreasure Ltd. (“PharmaTrialsCortex,” “we,” “us,” or “our”) governing your access to and use of the PharmaTrialsCortex website at pharmatrialscortex.com, our clinical trial technology platform applications (SmartEDC, TMFEye.ai, eCTMS), APIs, documentation, and all related services (collectively, the “Services”).

By accessing or using our Services, you agree to be bound by these Terms. If you are entering into these Terms on behalf of an organization, you represent and warrant that you have the authority to bind that organization. If you do not agree to these Terms, you must not access or use the Services.

These Terms apply to all users, including site administrators, study coordinators, data managers, monitors, investigators, and other personnel accessing the Services. Separate enterprise agreements, subscription agreements, or master service agreements, where executed, will take precedence over these Terms to the extent of any conflict.

Definitions

  • “Account” means the user account you create to access the Services.
  • “Clinical Trial Data” means any data entered, generated, or processed within the platform applications in connection with a clinical trial, including but not limited to electronic case report form (eCRF) data, adverse event reports, audit trail records, and electronic signatures.
  • “Content” means text, data, files, documents, graphics, and other materials uploaded, submitted, or transmitted through the Services.
  • “Customer” means the organization (sponsor, CRO, research institution) that has entered into a subscription agreement for the Services.
  • “Intellectual Property Rights” means all patents, copyrights, trademarks, trade secrets, and other proprietary rights.
  • “Platform Applications” means SmartEDC, TMFEye.ai, eCTMS, and any other PharmaTrialsCortex software products.
  • “Subscription” means the paid plan under which a Customer accesses the Services.

Account Terms

Account Creation

To access the Platform Applications, you must create an Account. You agree to:

  • Provide accurate, current, and complete information during registration.
  • Maintain the accuracy of your Account information.
  • Use a unique, individual Account. Shared accounts are prohibited. Each user who accesses the Services must have their own Account, as required by 21 CFR Part 11 Section 11.100.
  • Choose a strong password meeting our minimum requirements (at least 12 characters with a combination of uppercase, lowercase, numeric, and special characters).

Account Security

You are responsible for:

  • Maintaining the confidentiality of your Account credentials.
  • All activities that occur under your Account.
  • Notifying us immediately at security@pharmatrialscortex.com if you become aware of any unauthorized use of your Account.

PharmaTrialsCortex implements security controls including multi-factor authentication, automatic session timeout after 15 minutes of inactivity, and account lockout after 5 consecutive failed login attempts. These controls are required by 21 CFR Part 11 and cannot be disabled for accounts with access to clinical trial data.

Account Roles and Permissions

Access to features and data within the Services is governed by role-based access controls (RBAC). Your organization’s administrator assigns roles based on your job function. Available roles include, but are not limited to: Account Manager, Auditor, Clinician, Data Manager, Nurse, and Statistician. You agree to access only the data and functions appropriate to your assigned role.

Acceptable Use

You agree to use the Services only for lawful purposes and in accordance with these Terms. For detailed acceptable use requirements, please refer to our Acceptable Use Policy. In summary, you agree not to:

  • Use the Services for any purpose other than legitimate clinical trial operations or evaluation of the Services.
  • Attempt to gain unauthorized access to any part of the Services, other accounts, or connected systems.
  • Interfere with or disrupt the integrity or performance of the Services.
  • Reverse engineer, decompile, or disassemble any portion of the Services except as permitted by applicable law.
  • Upload or transmit viruses, malware, or other harmful code.
  • Use the Services to violate any applicable law, regulation, or third-party right.
  • Modify, delete, or tamper with audit trail records or electronic signatures.
  • Share, transfer, or sublicense your Account credentials to any other person.

Intellectual Property

PharmaTrialsCortex Proprietary Rights

PharmaTrialsCortex and its licensors own all Intellectual Property Rights in and to the Services, including the platform applications, documentation, branding, logos, design elements, source code, and proprietary algorithms. These Terms do not grant you any right, title, or interest in the Services except for the limited usage rights expressly set forth herein. The Services are proprietary software. Unauthorized copying, distribution, modification, or reverse engineering is strictly prohibited.

Your Content

You retain ownership of all Content you submit to or through the Services. By submitting Content, you grant PharmaTrialsCortex a limited, non-exclusive license to host, store, process, and display your Content solely for the purpose of providing the Services. We will not use your Content (including Clinical Trial Data) for any other purpose without your explicit written consent.

Feedback

If you provide feedback, suggestions, or ideas about the Services (“Feedback”), you grant PharmaTrialsCortex a perpetual, worldwide, royalty-free, irrevocable license to use, modify, and incorporate such Feedback into the Services without obligation to you.

Subscription Terms

Access to the Platform Applications requires an active Subscription. PharmaTrialsCortex offers the following subscription tiers:

  • Starter: For emerging biotech and academic research teams. Includes core EDC features with limited study and site capacity.
  • Professional: For growing research organizations. Includes the full AI suite, unlimited studies and sites, and priority support.
  • Enterprise: For CROs and large pharmaceutical organizations. Includes dedicated infrastructure, custom SSO, SLA guarantees, and white-label options.

Subscription pricing, features, and terms are described on our Pricing page and in any executed subscription agreement. All subscriptions are billed monthly or annually as selected. Prices are subject to change with 60 days’ notice.

Limitation of Liability

Disclaimer of Warranties

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SERVICES ARE PROVIDED “AS IS” AND “AS AVAILABLE” WITHOUT WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE. PHARMATRIALSCORTEX DISCLAIMS ALL WARRANTIES, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, AND ANY WARRANTIES ARISING OUT OF COURSE OF DEALING OR USAGE OF TRADE.

PHARMATRIALSCORTEX DOES NOT WARRANT THAT THE SERVICES WILL BE UNINTERRUPTED, ERROR-FREE, OR COMPLETELY SECURE, OR THAT ANY DEFECTS WILL BE CORRECTED.

Limitation of Damages

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL PHARMATRIALSCORTEX, ITS AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES, OR AGENTS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING WITHOUT LIMITATION LOSS OF PROFITS, DATA, USE, GOODWILL, OR OTHER INTANGIBLE LOSSES, REGARDLESS OF THE THEORY OF LIABILITY AND EVEN IF PHARMATRIALSCORTEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

PHARMATRIALSCORTEX’S AGGREGATE LIABILITY FOR ALL CLAIMS ARISING OUT OF OR RELATED TO THESE TERMS OR THE SERVICES SHALL NOT EXCEED THE GREATER OF: (A) THE AMOUNTS PAID BY YOU TO PHARMATRIALSCORTEX IN THE TWELVE (12) MONTHS PRECEDING THE CLAIM, OR (B) ONE HUNDRED U.S. DOLLARS ($100).

Clinical Data Disclaimer

THE SERVICES ARE DESIGNED TO ASSIST WITH CLINICAL TRIAL DATA MANAGEMENT. PHARMATRIALSCORTEX IS NOT A HEALTHCARE PROVIDER AND DOES NOT PROVIDE MEDICAL ADVICE. THE SERVICES DO NOT REPLACE PROFESSIONAL CLINICAL JUDGMENT. AI-GENERATED SUGGESTIONS AND AUTOMATED FEATURES ARE ADVISORY ONLY AND MUST BE REVIEWED AND APPROVED BY QUALIFIED PERSONNEL BEFORE ACTING UPON THEM.

Indemnification

You agree to indemnify, defend, and hold harmless PharmaTrialsCortex and its affiliates, officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, costs, and expenses (including reasonable attorneys’ fees) arising out of or related to:

  • Your use of the Services in violation of these Terms.
  • Your Content or Clinical Trial Data, including any claim that your Content infringes a third party’s Intellectual Property Rights.
  • Your violation of any applicable law, regulation, or third-party right.
  • Your failure to maintain the security of your Account.

This indemnification obligation shall survive termination of these Terms.

Termination

Termination by You

You may terminate your Account at any time by contacting support@pharmatrialscortex.com. Upon termination, your right to access the Services will cease. Subject to regulatory data retention requirements, we will delete or anonymize your data in accordance with our Privacy Policy.

Termination by PharmaTrialsCortex

We may suspend or terminate your access to the Services, in whole or in part, at any time and for any reason, including but not limited to:

  • Violation of these Terms or the Acceptable Use Policy.
  • Non-payment of applicable fees.
  • Extended inactivity (more than 12 months without login).
  • Conduct that we reasonably believe poses a risk to the security or integrity of the Services.

We will provide reasonable notice before termination where practicable, except in cases of imminent security risk or legal requirement.

Effect of Termination

Upon termination:

  • Your right to access the Services ceases immediately.
  • Clinical Trial Data will be retained as required by applicable regulations (typically 25 years for clinical trial records under ICH-GCP guidelines) and made available for export for 90 days after termination.
  • We will provide data export in standard formats (CDISC ODM, CSV) upon request within 90 days of termination.
  • Provisions that by their nature should survive termination shall survive, including but not limited to: Intellectual Property, Limitation of Liability, Indemnification, and Governing Law.

Governing Law

These Terms shall be governed by and construed in accordance with the laws of England and Wales, without regard to its conflict of law principles.

Nothing in these Terms shall affect the statutory rights of consumers that cannot be waived or limited by contract under applicable law.

Dispute Resolution

Informal Resolution

Before initiating formal dispute resolution, you agree to first contact us at support@pharmatrialscortex.com and attempt to resolve the dispute informally for at least 30 days.

Arbitration

If we cannot resolve the dispute informally, you and PharmaTrialsCortex agree to resolve any claim, dispute, or controversy arising out of or relating to these Terms through binding arbitration administered under the rules of the London Court of International Arbitration (LCIA). The arbitration shall be conducted in English in London, United Kingdom, unless the parties mutually agree to a different location or virtual proceeding.

Class Action Waiver

YOU AND PHARMATRIALSCORTEX AGREE THAT EACH PARTY MAY BRING CLAIMS AGAINST THE OTHER ONLY IN YOUR OR ITS INDIVIDUAL CAPACITY AND NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS, CONSOLIDATED, OR REPRESENTATIVE PROCEEDING.

Exceptions

Nothing in this section shall prevent either party from seeking injunctive or other equitable relief in a court of competent jurisdiction to prevent the actual or threatened infringement, misappropriation, or violation of Intellectual Property Rights.

Changes

We may modify these Terms from time to time. When we make material changes:

  • We will update the “Last Updated” date at the top of these Terms.
  • We will provide at least 30 days’ notice before material changes take effect, via email or in-app notification.
  • For changes affecting Clinical Trial Data handling, we will provide at least 60 days’ notice and obtain affirmative consent where required by applicable regulation.

Your continued use of the Services after the effective date of the updated Terms constitutes your acceptance of the changes. If you do not agree to the updated Terms, you must stop using the Services.

Contact

For questions or concerns about these Terms, contact us:

DataTreasure Ltd.