Terms of Service

By accessing, browsing, or using the ClinShield platform, website, or any of our Services, you acknowledge that you have read, understood, and agree to be bound by these Terms of Service, our Privacy Policy, and any additional terms, conditions, and policies referenced herein or available by hyperlink.

These Terms constitute a legally binding agreement between you (whether personally or on behalf of an entity) and ClinShield, Inc. If you are using the Services on behalf of a company, organization, or other entity, you represent and warrant that you have the authority to bind such entity to these Terms, in which case "you" and "your" shall refer to such entity.

If you do not agree to all of these Terms, you are expressly prohibited from using the Services and must discontinue use immediately. Your continued use of the Services following the posting of revised Terms means that you accept and agree to the changes.

You must be at least 18 years of age to use our Services. By using our Services, you represent and warrant that you are at least 18 years of age and have the legal capacity to enter into these Terms.

ClinShield provides a software-as-a-service (SaaS) platform designed to assist users in analyzing clinical trial protocols for compliance with regulatory standards, including but not limited to ICH E6 (R2) Good Clinical Practice guidelines, FDA requirements, EMA guidelines, and other applicable global regulatory frameworks.

The Services include, but are not limited to:

• Automated protocol compliance analysis using artificial intelligence and machine learning technologies
• Generation of compliance reports identifying potential issues, gaps, and areas of concern
• Evidence chain documentation linking findings to specific regulatory requirements
• Remediation guidance and recommendations
• Document upload, storage, and management capabilities
• Report export and sharing functionality

The Services are provided as informational and analytical tools only. ClinShield does not guarantee regulatory approval, acceptance, or compliance of any protocol analyzed through our platform. The final determination of regulatory compliance rests solely with the applicable regulatory authorities.

To access certain features of the Services, you may be required to register for an account. When registering, you agree to:

• Provide accurate, current, and complete information during the registration process
• Maintain and promptly update your account information to keep it accurate, current, and complete
• Maintain the security and confidentiality of your account credentials, including your password
• Accept responsibility for all activities that occur under your account
• Immediately notify ClinShield of any unauthorized use of your account or any other breach of security

You may not use another person's account without permission. You may not share your account credentials with any third party. ClinShield reserves the right to disable any user account at any time in our sole discretion for any or no reason, including if we believe that you have violated any provision of these Terms.

You are solely responsible for any activity that occurs through your account, whether or not authorized by you. ClinShield will not be liable for any loss or damage arising from your failure to comply with the above requirements.

You agree not to use the Services for any purpose that is prohibited by these Terms. You may not use the Services:

• For any unlawful purpose or in violation of any applicable local, state, national, or international law or regulation
• To upload, transmit, or distribute any content that is illegal, harmful, threatening, abusive, harassing, defamatory, vulgar, obscene, or otherwise objectionable
• To upload, transmit, or distribute any content that infringes upon the intellectual property rights or proprietary rights of any third party
• To upload any content containing viruses, malware, Trojan horses, worms, or other harmful or destructive code
• To attempt to gain unauthorized access to any portion of the Services, other accounts, computer systems, or networks connected to the Services
• To interfere with or disrupt the Services or servers or networks connected to the Services
• To reverse engineer, decompile, disassemble, or otherwise attempt to derive the source code of the Services
• To use any automated system, including robots, spiders, or scrapers, to access the Services
• To collect or harvest any personally identifiable information from the Services
• To use the Services in any manner that could disable, overburden, damage, or impair the Services
• To impersonate or attempt to impersonate ClinShield, a ClinShield employee, another user, or any other person or entity
• To resell, sublicense, or otherwise commercially exploit the Services without ClinShield's prior written consent
• To use any information obtained from the Services to harass, abuse, or harm another person

ClinShield reserves the right to terminate your access to the Services immediately and without notice for any violation of these prohibited uses.

5.1 User Content

"User Content" refers to any content, data, documents, protocols, materials, or information that you upload, submit, store, transmit, or otherwise make available through the Services. You retain all ownership rights in your User Content.

By uploading User Content to the Services, you grant ClinShield a limited, non-exclusive, royalty-free, worldwide license to use, process, copy, store, and display your User Content solely for the purpose of providing the Services to you. This license terminates when you delete your User Content or your account, except to the extent required for backup, archival, or legal compliance purposes.

5.2 Your Responsibilities

You represent and warrant that:

• You own or have the necessary licenses, rights, consents, and permissions to upload and use your User Content
• Your User Content does not infringe upon the intellectual property rights, privacy rights, or any other rights of any third party
• Your User Content does not contain any confidential information belonging to a third party that you are not authorized to disclose
• Your User Content complies with all applicable laws and regulations

5.3 ClinShield Intellectual Property

The Services, including all content, features, functionality, software, algorithms, designs, graphics, trademarks, service marks, and logos contained therein, are owned by ClinShield, its licensors, or other providers and are protected by United States and international copyright, trademark, patent, trade secret, and other intellectual property laws.

These Terms do not grant you any right, title, or interest in the Services or any ClinShield intellectual property. You may not copy, modify, distribute, sell, lease, or create derivative works based on the Services or any ClinShield intellectual property without our express written permission.

You acknowledge and agree that:

• AI-generated outputs may contain errors, inaccuracies, omissions, or incomplete information
• AI systems are not infallible and may produce results that are incorrect, misleading, or inappropriate for your specific circumstances
• All AI-generated analyses and recommendations must be independently verified and reviewed by qualified professionals before use in any regulatory context
• ClinShield does not guarantee the accuracy, completeness, reliability, or suitability of any AI-generated content
• You are solely responsible for evaluating and verifying the appropriateness of any AI-generated content for your intended use
• ClinShield shall not be liable for any decisions made or actions taken based on AI-generated content

The use of AI in the Services is intended to augment, not replace, professional human judgment and expertise. You should always consult with qualified regulatory, medical, and legal professionals before making decisions that may affect clinical trials, patient safety, or regulatory compliance.

You acknowledge and agree that:

• The Services do not create any attorney-client, physician-patient, or other professional relationship between you and ClinShield
• Any information provided through the Services is general in nature and may not be applicable to your specific situation
• You must consult with qualified medical, legal, and regulatory professionals for advice specific to your clinical trials and regulatory submissions
• ClinShield employees and representatives are not licensed to practice medicine, law, or provide regulatory consulting services in any jurisdiction
• Decisions affecting patient safety, clinical trial conduct, or regulatory compliance should only be made in consultation with appropriately qualified professionals

ClinShield expressly disclaims any and all liability arising from your reliance on the Services as a substitute for professional medical, legal, or regulatory advice.

The Services are designed to assist in identifying potential compliance issues with regulatory standards and guidelines. However, ClinShield makes no representations or warranties that:

• The Services will identify all compliance issues or deficiencies in any protocol
• Protocols analyzed by the Services will be approved or accepted by any regulatory authority
• The regulatory standards and guidelines referenced in the Services are current, complete, or applicable to your specific jurisdiction or circumstances
• Use of the Services will ensure compliance with any regulatory requirements

Regulatory requirements vary by jurisdiction, therapeutic area, trial phase, and other factors. The Services provide general guidance based on widely applicable standards but cannot account for all jurisdiction-specific requirements or the specific circumstances of your clinical trial.

You are solely responsible for ensuring that your clinical trial protocols comply with all applicable laws, regulations, and guidelines in all relevant jurisdictions. You should always verify compliance requirements with the applicable regulatory authorities and qualified regulatory consultants.

9.1 Service Tiers

ClinShield offers multiple service tiers:

• Free Tier: Limited to one (1) protocol analysis per email address, with watermarked, view-only reports
• Pilot Program: Discounted pricing for early adopters, subject to availability and eligibility requirements
• Paid Plans: Full-featured access with downloadable reports, subject to current pricing

9.2 Pricing and Payment

Current pricing for all service tiers is available on our website. All prices are quoted in United States Dollars (USD) unless otherwise specified. Prices are subject to change at any time without notice, except that price changes will not affect orders that have already been placed and paid for.

Payment is due at the time of purchase or as otherwise specified. We accept payment methods as indicated on our website. You agree to provide current, complete, and accurate billing information and to promptly update this information if it changes.

9.3 Taxes

All fees are exclusive of applicable taxes, levies, or duties imposed by taxing authorities. You are responsible for payment of all such taxes, levies, or duties, excluding only United States (federal or state) taxes based solely on ClinShield's net income.

9.4 Refunds

ClinShield offers a 30-day money-back guarantee for paid services. If you are not satisfied with the Services, you may request a full refund within 30 days of your purchase. Refund requests should be submitted to our support team. Refunds are processed using the original payment method and may take 5-10 business days to appear in your account.

9.5 Chargebacks and Disputes

If you have a concern about a charge, please contact us before initiating a chargeback with your payment provider. Initiating a chargeback without first contacting ClinShield may result in immediate termination of your account and forfeiture of any remaining services or credits.

10.1 Subscription Terms

If you subscribe to a recurring service plan, your subscription will automatically renew at the end of each billing period unless you cancel before the renewal date. The renewal period and billing cycle will be as specified at the time of your initial subscription.

10.2 Cancellation

You may cancel your subscription at any time through your account settings or by contacting our support team. Cancellation will take effect at the end of the current billing period. You will continue to have access to paid features until the end of the billing period for which you have already paid.

10.3 No Refunds for Partial Periods

Except as provided in our refund policy, no refunds or credits will be issued for partial subscription periods or unused services. If you cancel your subscription, you will not receive a refund for any remaining time in your current billing period.

10.4 Effect of Cancellation

Upon cancellation or termination of your subscription, you will lose access to paid features and any data or reports associated with your account may be deleted. We recommend downloading any reports or data you wish to retain before canceling your subscription.

11.1 Privacy Policy

Your use of the Services is subject to our Privacy Policy, which is incorporated into these Terms by reference. Please review our Privacy Policy to understand how we collect, use, and protect your information.

11.2 Data Security

ClinShield implements reasonable administrative, technical, and physical security measures designed to protect your data from unauthorized access, use, alteration, or destruction. However, no method of transmission over the Internet or method of electronic storage is 100% secure.

While we strive to protect your data, we cannot guarantee absolute security. You acknowledge and agree that you provide your data at your own risk, and ClinShield shall not be liable for any unauthorized access to, use of, or disclosure of your data except to the extent caused by our gross negligence or willful misconduct.

11.3 GDPR Compliance

For users in the European Economic Area (EEA), United Kingdom, or Switzerland, ClinShield processes personal data in accordance with the General Data Protection Regulation (GDPR) and applicable local data protection laws. Our Privacy Policy describes the legal bases for processing, data subject rights, and international data transfers.

11.4 HIPAA Considerations

ClinShield is not a "Covered Entity" or "Business Associate" as defined under the Health Insurance Portability and Accountability Act (HIPAA). You should not upload any Protected Health Information (PHI) as defined by HIPAA to the Services unless you have executed a separate Business Associate Agreement (BAA) with ClinShield.

If you require HIPAA compliance for your use of the Services, please contact us to discuss available options.

11.5 Data Breach Notification

In the event of a data breach affecting your personal data, ClinShield will notify you in accordance with applicable laws and regulations. We will provide information about the breach, the types of data affected, and the steps we are taking to address the breach and prevent future occurrences.

12.1 Maximum Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE TOTAL LIABILITY OF CLINSHIELD FOR ANY CLAIMS ARISING OUT OF OR RELATING TO THESE TERMS OR THE SERVICES SHALL NOT EXCEED THE GREATER OF: (A) THE AMOUNTS YOU HAVE PAID TO CLINSHIELD IN THE TWELVE (12) MONTHS PRIOR TO THE EVENT GIVING RISE TO LIABILITY; OR (B) ONE HUNDRED UNITED STATES DOLLARS ($100.00).

12.2 Basis of the Bargain

YOU ACKNOWLEDGE AND AGREE THAT CLINSHIELD HAS OFFERED ITS SERVICES AND ENTERED INTO THESE TERMS IN RELIANCE UPON THE DISCLAIMERS AND LIMITATIONS OF LIABILITY SET FORTH HEREIN. THESE LIMITATIONS FORM AN ESSENTIAL BASIS OF THE BARGAIN BETWEEN YOU AND CLINSHIELD. CLINSHIELD WOULD NOT BE ABLE TO PROVIDE THE SERVICES TO YOU ON AN ECONOMICALLY REASONABLE BASIS WITHOUT THESE LIMITATIONS.

12.3 Jurisdictional Limitations

Some jurisdictions do not allow the exclusion or limitation of certain damages. In such jurisdictions, the limitations above shall apply to the maximum extent permitted by applicable law. Nothing in these Terms shall exclude or limit liability for death or personal injury caused by negligence, fraud, or any other liability that cannot be excluded or limited by applicable law.

• Your use of the Services or any activity conducted through your account
• Your User Content or any content you submit, post, or transmit through the Services
• Your violation of these Terms or any applicable law or regulation
• Your violation of any third-party rights, including intellectual property rights, privacy rights, or contractual rights
• Any claim that your User Content caused damage to a third party
• Your negligence or willful misconduct
• Any dispute between you and any third party arising from or relating to your use of the Services

ClinShield reserves the right, at your expense, to assume the exclusive defense and control of any matter for which you are required to indemnify us, and you agree to cooperate with our defense of such claims. You agree not to settle any such matter without the prior written consent of ClinShield. ClinShield will use reasonable efforts to notify you of any such claim, action, or proceeding upon becoming aware of it.

CLINSHIELD DOES NOT WARRANT THAT:

• The Services will be uninterrupted, timely, secure, or error-free
• The results obtained from the use of the Services will be accurate, reliable, or complete
• The quality of any products, services, information, or other material obtained through the Services will meet your expectations
• Any errors in the Services will be corrected
• The Services will be compatible with your computer, mobile device, or other equipment
• The Services will be free from viruses, malware, or other harmful components

Any content downloaded or otherwise obtained through the use of the Services is accessed at your own discretion and risk, and you will be solely responsible for any damage to your computer system or loss of data that results from the download of any such content.

No advice or information, whether oral or written, obtained from ClinShield or through the Services shall create any warranty not expressly stated in these Terms.

15.1 Modifications to Services

ClinShield reserves the right to modify, suspend, or discontinue the Services, in whole or in part, at any time and without notice or liability. This includes the right to add, remove, or modify features, functionality, or content of the Services.

15.2 Service Interruptions

The Services may be subject to interruptions, delays, errors, or other limitations due to:

• Scheduled maintenance or updates
• Unscheduled maintenance or emergency repairs
• System failures or technical issues
• Actions by third-party service providers
• Cyberattacks or security incidents
• Natural disasters or other events beyond our reasonable control
• Compliance with legal or regulatory requirements

ClinShield will use commercially reasonable efforts to minimize service interruptions but makes no guarantee of continuous availability. We are not liable for any interruption or delay in accessing the Services.

15.3 No Liability for Modifications or Interruptions

ClinShield shall not be liable to you or any third party for any modification, suspension, or discontinuation of the Services or any part thereof. You agree that ClinShield shall not be liable for any losses, damages, or inconvenience arising from any interruption or unavailability of the Services.

16.1 Termination by You

You may terminate your account and stop using the Services at any time by contacting us or through your account settings. Upon termination, you will lose access to the Services and any data or content associated with your account.

16.2 Termination by ClinShield

ClinShield may terminate or suspend your account and access to the Services, in whole or in part, immediately and without prior notice or liability, for any reason, including but not limited to:

• Breach of these Terms
• Violation of applicable laws or regulations
• Fraudulent, abusive, or illegal activity
• Non-payment of fees
• Requests by law enforcement or government agencies
• Extended periods of inactivity
• Discontinuation of the Services
• Any other reason at our sole discretion

16.3 Effect of Termination

Upon termination of your account:

• Your right to access and use the Services will immediately cease
• You will not be entitled to any refund of fees paid, except as provided in our refund policy
• ClinShield may delete your account information and User Content, subject to our data retention policies
• Provisions of these Terms that by their nature should survive termination shall survive, including intellectual property rights, warranty disclaimers, limitation of liability, indemnification, and dispute resolution provisions

17.1 Agreement to Arbitrate

You and ClinShield agree that any dispute, claim, or controversy arising out of or relating to these Terms or the Services, including the determination of the scope or applicability of this agreement to arbitrate, shall be resolved exclusively through final and binding arbitration, rather than in court.

17.2 Arbitration Rules and Procedures

Arbitration shall be conducted in accordance with the Commercial Arbitration Rules of the American Arbitration Association ("AAA") in effect at the time of the dispute. The arbitration shall be conducted by a single arbitrator selected in accordance with AAA rules.

The arbitration shall be held in the State of Delaware or, at your election, may be conducted by telephone, online, or based solely on written submissions. The arbitrator shall apply the substantive law of the State of Delaware, excluding its conflict of laws rules.

17.3 Class Action Waiver

YOU AND CLINSHIELD 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, COLLECTIVE, OR REPRESENTATIVE PROCEEDING. THE ARBITRATOR MAY NOT CONSOLIDATE MORE THAN ONE PERSON'S CLAIMS AND MAY NOT OTHERWISE PRESIDE OVER ANY FORM OF A CLASS, COLLECTIVE, OR REPRESENTATIVE PROCEEDING.

17.4 Waiver of Jury Trial

BY AGREEING TO ARBITRATION, YOU AND CLINSHIELD ARE EACH WAIVING THE RIGHT TO A TRIAL BY JURY. YOU ACKNOWLEDGE THAT YOU HAVE READ THIS PROVISION AND IRREVOCABLY AND UNCONDITIONALLY WAIVE ANY RIGHT YOU MAY HAVE TO A JURY TRIAL.

17.5 Exceptions to Arbitration

Notwithstanding the above, either party may seek injunctive or other equitable relief in any court of competent jurisdiction to prevent the actual or threatened infringement, misappropriation, or violation of intellectual property rights.

17.6 Opt-Out Right

You may opt out of this arbitration agreement by sending written notice of your decision to opt out to legal@clinshield.com within 30 days of first accepting these Terms. Your notice must include your name, address, email address, and a clear statement that you wish to opt out of the arbitration provision.

These Terms and your use of the Services shall be governed by and construed in accordance with the laws of the State of Delaware, United States, without regard to its conflict of law provisions.

To the extent that arbitration is not applicable or is determined to be unenforceable, you agree that any legal action or proceeding arising out of or relating to these Terms or the Services shall be brought exclusively in the state or federal courts located in Delaware, and you hereby consent to the personal jurisdiction and venue of such courts.

The United Nations Convention on Contracts for the International Sale of Goods does not apply to these Terms.

18.1 Export Controls

The Services may be subject to United States export control laws and regulations, including the Export Administration Regulations (EAR). You agree to comply with all applicable export laws and regulations and not to export, re-export, or transfer the Services to any prohibited country, entity, or person without the appropriate government authorizations.

You represent and warrant that you are not located in, under the control of, or a national or resident of any country subject to United States sanctions or embargoes, and that you are not on any United States government restricted party list.

ClinShield reserves the right to modify, update, or replace these Terms at any time in our sole discretion. If we make material changes to these Terms, we will provide notice through the Services, by email, or by other means as required by applicable law.

The "Last Updated" date at the top of these Terms indicates when the Terms were last revised. Changes are effective immediately upon posting, unless otherwise stated.

Your continued use of the Services after any changes to these Terms constitutes your acceptance of the revised Terms. If you do not agree to the revised Terms, you must stop using the Services.

It is your responsibility to review these Terms periodically for any changes. We encourage you to check this page frequently for updates.

If you have any questions, concerns, or comments about these Terms of Service, please contact us:

For legal notices or service of process, please contact us at legal@clinshield.com with "Legal Notice" in the subject line.