Terms of Service

1. Introduction and Acceptance

These Terms of Service (“Terms”) govern access to and use of the TrialStack platform, APIs, and related services (collectively, the “Service”) provided by TrialStack ApS, a Danish limited liability company with registered address at Copenhagen, Denmark (“TrialStack”, “we”, “us”, “our”).

By accessing or using the Service, clicking “I accept”, or executing an Order Form that references these Terms, the organisation or individual doing so (“Customer”, “you”) agrees to be bound by these Terms. If you are accepting on behalf of an organisation, you warrant that you have authority to bind that organisation.

If you do not agree to these Terms, do not access or use the Service.

2. Definitions

“Authorised User” means an individual employed by or contracted to Customer who is granted access to the Service under Customer’s account.

“Customer Content” means all data, documents, study configurations, protocol definitions, and other content submitted to the Service by Customer or its Authorised Users.

“Documentation” means TrialStack’s technical and user documentation made available within the platform.

“Order Form” means a written or electronic order that specifies the Subscription Plan, fees, and other commercial terms agreed between TrialStack and Customer.

“Subscription Plan” means the specific tier of access (Studio or Enterprise) and associated features purchased by Customer.

“Trial Period” means a free pilot period (if any) agreed in writing, during which Customer may evaluate the Service.

3. The Service

3.1 TrialStack provides an AI-native clinical trial documentation platform that assists clinical research organisations, sponsors, and academic institutions in generating structured evidence packs, regulatory documentation, and related artefacts for clinical trials.

3.2 TrialStack reserves the right to modify, update, or discontinue features of the Service with reasonable notice to Customers. Material reductions in functionality will be communicated with at least 30 days’ notice.

3.3 The Service is not a substitute for professional medical, legal, or regulatory advice. Customers remain solely responsible for the accuracy, completeness, and regulatory compliance of all documents produced using the Service.

3.4 The Service does not process patient-level clinical trial data or Protected Health Information (PHI). All content generated through the Service relates to clinical trial operational and regulatory documentation at the protocol and study configuration level.

4. Account Registration and Access

4.1 Customer must register for an account to access the Service. Account registration requires a valid work email address and accurate organisational information.

4.2 Customer is responsible for maintaining the confidentiality of account credentials and for all activities that occur under its account. Customer must notify TrialStack immediately at security@trialstack.com of any suspected unauthorised access.

4.3 TrialStack uses Clerk, Inc. as its identity and authentication provider. Account creation and access is subject to Clerk’s terms and policies as well as these Terms.

4.4 Customer may provision Authorised Users up to the limit specified in the applicable Order Form or Subscription Plan. Each Authorised User must be an individual - account sharing is not permitted.

5. Subscription Plans and Payment

5.1 Access to the Service (beyond any Trial Period) requires a paid Subscription Plan as described in the applicable Order Form or TrialStack’s published pricing page.

5.2 Fees are billed in advance, either monthly or annually as specified in the Order Form. All fees are exclusive of applicable taxes (including VAT), which are the Customer’s responsibility.

5.3 Payment is due within 30 days of invoice date. Late payments accrue interest at 2% per month.

5.4 TrialStack may update pricing with 60 days’ written notice. Price increases will not take effect until the Customer’s next renewal period.

5.5 Except as expressly set out in these Terms or an Order Form, all fees are non-refundable.

5.6 Trial Period. If Customer is granted a Trial Period, access during that period is provided free of charge on an “as-is” basis with no SLA or support commitments. At the end of the Trial Period, continued access requires a paid subscription. TrialStack may terminate a Trial Period at any time with 7 days’ notice.

6. Acceptable Use

6.1 Customer agrees not to, and shall ensure its Authorised Users do not:

• Use the Service to process patient-level personally identifiable health data or PHI without express written agreement with TrialStack.
• Attempt to reverse-engineer, decompile, or extract the underlying AI models or proprietary algorithms of the Service.
• Use the Service to generate fraudulent, misleading, or knowingly inaccurate regulatory submissions.
• Share access credentials or circumvent user provisioning limits.
• Conduct load testing, automated scraping, or other activities that place unreasonable load on the Service infrastructure.
• Use the Service in violation of any applicable law or regulation.

6.2 TrialStack reserves the right to suspend access where Acceptable Use obligations are breached, pending investigation.

7. Intellectual Property

7.1 TrialStack IP. All rights in the Service, including the platform, AI models, evidence pack templates, user interface, documentation, and underlying technology, are owned by TrialStack or its licensors. These Terms do not transfer any ownership rights to Customer.

7.2 Customer Content. Customer retains all ownership rights in Customer Content. By submitting Customer Content to the Service, Customer grants TrialStack a limited, non-exclusive, royalty-free licence to process and store that content solely to deliver the Service.

7.3 Output Content. Documents, reports, and other outputs generated by the Service (“Outputs”) based on Customer Content are owned by Customer, subject to TrialStack’s underlying template and model rights. Customer is solely responsible for reviewing, validating, and taking responsibility for Outputs before use.

7.4 Feedback. If Customer provides feedback, suggestions, or ideas about the Service, TrialStack may use them without restriction or compensation.

8. Data and Privacy

8.1 The parties’ data protection obligations are governed by TrialStack’s Data Processing Agreement (“DPA”), available at trust.trialstack.com, which is incorporated into these Terms by reference.

8.2 TrialStack processes personal data in accordance with its Privacy Policy (available at trialstack.com/privacy) and applicable law, including EU GDPR 2016/679 and the Danish Data Protection Act.

8.3 TrialStack maintains a Subprocessor Register (GDPR-SR-v1.0) listing all third-party processors engaged in delivering the Service. The current register is available at trust.trialstack.com.

9. Confidentiality

9.1 Each party may receive confidential information of the other (“Confidential Information”) in connection with the Service. Each party agrees to: (a) keep Confidential Information strictly confidential; (b) use it only for the purposes of these Terms; and (c) disclose it only to employees or contractors who need to know it and are bound by equivalent obligations.

9.2 Confidentiality obligations do not apply to information that: (a) is or becomes publicly known through no breach; (b) was already known prior to disclosure; (c) is independently developed; or (d) is required to be disclosed by law or court order, provided the disclosing party gives prompt notice where permitted.

10. Warranties and Disclaimers

10.1 TrialStack warrants that the Service will operate materially in accordance with the Documentation under normal use conditions.

10.2 TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SERVICE IS PROVIDED “AS IS”. TRIALSTACK MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. TRIALSTACK DOES NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED, ERROR-FREE, OR THAT ALL ERRORS WILL BE CORRECTED.

10.3 AI-generated content within the Service may contain errors or inaccuracies. Customer is responsible for independently reviewing and verifying all Outputs before reliance or submission to any regulatory authority.

11. Limitation of Liability

11.1 TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, NEITHER PARTY WILL BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR LOSS OF PROFIT DAMAGES, EVEN IF ADVISED OF THE POSSIBILITY.

11.2 TRIALSTACK’S TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS WILL NOT EXCEED THE FEES PAID BY CUSTOMER TO TRIALSTACK IN THE TWELVE (12) MONTHS IMMEDIATELY PRECEDING THE CLAIM.

11.3 The exclusions and limitations in this Section will not apply to: (a) death or personal injury caused by negligence; (b) fraud or fraudulent misrepresentation; or (c) any liability that cannot be excluded under applicable Danish law.

12. Indemnification

Customer will indemnify, defend, and hold TrialStack harmless from any third-party claims, losses, damages, and costs (including reasonable legal fees) arising from: (a) Customer’s breach of these Terms; (b) Customer’s misuse of the Service; or (c) Customer Content that infringes any third-party intellectual property right or violates applicable law.

13. Term and Termination

13.1 These Terms commence on the date Customer first accepts them and continue until terminated.

13.2 Either party may terminate a Subscription Plan by providing 30 days’ written notice prior to the end of the then-current subscription period. No refunds are due for the remaining subscription period following a Customer-initiated termination.

13.3 TrialStack may terminate these Terms immediately upon written notice if: (a) Customer materially breaches these Terms and fails to cure within 14 days; (b) Customer becomes insolvent or subject to insolvency proceedings; or (c) TrialStack is legally required to do so.

13.4 Effect of Termination. Upon termination: (a) Customer’s access to the Service will cease; (b) Customer may export Customer Content within 30 days of termination date using the Service’s export functionality; (c) after 30 days, TrialStack will delete Customer Content in accordance with its Data Retention Policy.

14. Governing Law and Dispute Resolution

14.1 These Terms are governed by the laws of the Kingdom of Denmark, without regard to its conflict of law provisions.

14.2 Any disputes arising out of or in connection with these Terms that cannot be resolved amicably shall be subject to the exclusive jurisdiction of the Copenhagen City Court (Kobenhavns Byret), Denmark.

15. General Provisions

15.1 Entire Agreement. These Terms, together with any applicable Order Form and the DPA, constitute the entire agreement between the parties and supersede all prior agreements relating to the Service.

15.2 Amendment. TrialStack may update these Terms by providing 30 days’ written notice. Continued use of the Service after the effective date constitutes acceptance. Material changes will be highlighted in the notice.

15.3 Waiver. Failure to enforce any right under these Terms does not constitute a waiver of that right.

15.4 Severability. If any provision is held invalid or unenforceable, it will be modified to the minimum extent necessary, and the remaining provisions will continue in full force.

15.5 Assignment. Customer may not assign these Terms without TrialStack’s prior written consent. TrialStack may assign these Terms in connection with a merger, acquisition, or sale of substantially all assets.

15.6 Force Majeure. Neither party is liable for delays or failures caused by events beyond its reasonable control.

15.7 Notices. Legal notices must be in writing and sent to legal@trialstack.com (for TrialStack) or the email address on Customer’s account (for Customer).

16. Contact

TrialStack ApS Copenhagen, Denmark legal@trialstack.com trust.trialstack.com