Terms of Use

1. The Services

Trialetics provides the Trialetics product, our online, on-demand, software-as-a-service Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) product located at https://www.trialetics.io/ and associated subdomains ("Trialetics Modules") and our related content, features, applications, and other services (collectively with Trialetics, the "Service(s)"). In addition to our core CTMS platform, Trialetics offers custom software development services and Excel to SaaS conversion services, transforming spreadsheet-based workflows into scalable, compliant software solutions tailored to the unique needs of clinical trial operations. We also provide ready-to-use modules available through our App Store, offering immediate deployment of pre-built solutions for common clinical trial management needs without the time and cost of custom development.

The Service allows Clients and their individual employees and contractors (or any other individuals designated by Client) who require access to the Services ("Authorized Users") to perform detailed clinical trial management activities in the pharmaceutical, biotechnology, medical device and life sciences industries. This includes contacts and organizations, calendars, tasks and milestones, contracts and payments, performance targets and metrics, documents, monitoring activities, and study subject metadata.

IMPORTANT: This does not include case report forms, randomization, electronic health records storage or processing, or the collection of Protected Health Information ("PHI") as that term is defined under the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder ("HIPAA").

You can browse our websites pursuant to these Terms. Organizations that wish to access Trialetics need to enter into a Master Services Agreement or similar agreement ("Agreement") and complete the registration process to create an account for the organization ("Client") and each of the Client's Authorized Users. Notwithstanding anything to the contrary herein, in the event any agreement you or the legal entity you represent may have with Trialetics regarding the Service conflicts with these Terms, that agreement (and not these Terms) will prevail to the extent necessary to resolve the inconsistency or conflict.

2. Additional Terms and Policies

Your use of our Service is subject to our Privacy Policy for Web Visitors and our Privacy Policy for Subscribers, as applicable. By accessing our websites or using the Service, you consent to these policies, to the extent applicable to you, and you also agree to abide by any other policies or guidance we may post or otherwise make available from time to time which, to the extent indicated as being mandatory in such policy, are hereby incorporated by reference into these Terms (collectively "Company Policies").

3. Modifications

To the extent allowed by law, Trialetics reserves the right, in its sole discretion, to modify these Terms or our Company Policies at any time, with email notification to Clients no less than thirty (30) days prior to the effective date of the change. Notification will be provided to all Authorized Users with an active account, as well as an optional Client email address that can be populated within the subscription settings of the Service.

You should review these Terms and our Company Policies regularly. Given the thirty (30) day notice, your continued use of the Service on or after the effective date of modifications to these Terms constitutes acceptance of those changes. If you object to any such changes, your sole recourse is to stop using our Service.

4. Authorized User Eligibility

To access certain Services, including the Trialetics Modules, you must create an individual account as described below. Trialetics offers its Service for business purposes, and not for personal, household, or consumer use. All Authorized Users must be of legal age in the jurisdiction in which they reside and capable of forming a binding contract with us.

By creating an account, you agree to abide by these terms. Trialetics reserves the right, in its sole discretion, to refuse, suspend, or terminate access to the Service upon discovery that any information provided is not true, accurate, or complete, or otherwise violates these Terms.

You may not create an account if you are: (a) a citizen or resident of a geographic area in which access or use of the Service is prohibited by applicable law; (b) a citizen or resident of an area subject to U.S. or other sanctions or embargoes; or (c) identified on U.S. sanctioned or denied persons lists.

5. Authorized User Accounts

To use the Service, you must create a unique account by providing a unique email address, selecting a password, and providing accurate, current and complete information. You must maintain and promptly update this information to keep it accurate.

If a Client provided you with your account, you understand that this Client has rights to your account and may: (a) manage your account; (b) reset your password; (c) view your usage data; and (d) view and manage the content you enter into the Service.

Important: Use of a single Authorized User account by multiple people is prohibited. You are responsible for all activity that occurs on your account and must maintain the confidentiality of your password. You must notify us immediately of any unauthorized use of your account.

6. Privacy and Data Security

7. Unauthorized Use of Service

You acknowledge and agree that you must not, and you must not authorize or encourage any third party to:

1. Use another individual's account or share your password with any unauthorized person
2. Attempt to decipher, decompile, or reverse engineer the Service software
3. Modify, adapt, or hack the Service or attempt unauthorized access
4. Defame, abuse, harass, stalk, threaten, or violate the legal rights of others
5. Transmit any unlawful, defamatory, obscene, or inappropriate content
6. Transmit content that infringes intellectual property rights
7. Transmit files containing viruses or harmful programs
8. Use the Service for unauthorized commercial purposes
9. Transmit spam, unsolicited advertising, or chain letters
10. Download files that cannot be legally obtained
11. Falsify author attributions or proprietary notices
12. Restrict or inhibit other users from using the Service
13. Collect or store personal data beyond business requirements
14. Interfere with or disrupt the Service, servers, or networks
15. Perform unauthorized testing on production environments
16. Impersonate any person or entity
17. Use the Service for unlawful purposes
18. Store or transmit PHI, sensitive data, or improperly obtained personal data

YOU MAY USE THE SERVICE ONLY FOR LAWFUL AND APPROPRIATE INTERNAL BUSINESS PURPOSES. We reserve the right to suspend or permanently deactivate your account for violations. Trialetics will be entitled to seek injunctive relief for serious violations without the need to prove damages.

8. Third Party Websites

As part of the Service, Trialetics may provide links to third-party websites ("Third-Party Sites") and content or items from third parties ("Third-Party Applications, Software or Content"). These links are provided as a courtesy. Trialetics has no control over and is not responsible for Third-Party Sites or Third-Party Applications, Software or Content.

Inclusion of or linking to any Third-Party Site does not imply approval or endorsement by Trialetics. If you access Third-Party Sites or use Third-Party Applications, you do so at your own risk. Our terms and policies no longer govern once you leave the Service.

9. Digital Signature

By registering to use Trialetics's Service, you are deemed to have executed these Terms electronically, pursuant to applicable electronic signature laws including the U.S. Electronic Signatures in Global and National Commerce Act (15 U.S.C. § 7001, et seq.). Your registration constitutes acknowledgement that you can electronically receive, download, and print these Terms.

10. Consent to Use Electronic Records

In connection with these Terms, you may be entitled to receive certain records in writing. To facilitate your use of the Service, you give us permission to provide these records to you electronically instead of in paper form.

11. Right to Withdraw Consent

By registering to use Trialetics's Services, you consent to electronically receive and access, via email or the Service, all records and notices. Trialetics will generally communicate with you electronically; however, we reserve the right to communicate via U.S. Postal Service using your registered address.

Your consent will remain in effect until you withdraw it by cancelling your subscription. To ensure Trialetics can provide records electronically, you must maintain your email address in the application.

12. Term

This Agreement commences upon the date you create an account or otherwise begin using the Service. Data related to your account remains available until the Agreement with the Client has been terminated or your access is terminated by the Client.

13. License

14. Trademarks and Copyrights

"Trialetics Technologies LLC", "Trialetics", the Trialetics logos and any other product or service names contained in the Service are trademarks of Trialetics and may not be copied, imitated or used without prior written permission. You may not use metatags or hidden text utilizing "Trialetics Technologies" or related names without authorization.

The look and feel of the Service, including page headers, custom graphics, reports, and document templates, are the service mark, trademark, trade dress and/or copyright of Trialetics and may not be copied without permission.

15. Export Control

This Service and Materials may be subject to U.S. export control and economic sanctions laws. Trialetics makes no representation that materials are appropriate or available for use outside the United States. Those who access the Service from other locations do so on their own initiative and are responsible for compliance with applicable laws and regulations.

16. Support & Service Level

All Authorized Users receive support via email and web during regular business hours (8 AM – 5 PM Central Time, in English). Phone support is not included as a core service but may be available through Professional Services.

Additional support details, including Service Level Availability (SLA) terms and support ticket classifications, are available per the Master Services Agreement governing your use of the Service.

An "Error" means a material failure of the Service to perform as documented. Trialetics's responsibility is to use commercially reasonable efforts to correct reported Errors, which may consist of patches, workarounds, or inclusion in future releases.

Trialetics reserves the right to change or upgrade equipment, software, or features without notice. We will install security patches and updates as determined in our sole discretion. Downgrade of the Service by the Client may cause loss of features, content, or capacity.

17. Technical Requirements

Authorized Users must access the Service via high-speed internet connection of at least 10 Mbps down and 2 Mbps up (recommended speeds: 50 Mbps down and 10 Mbps up). You must enable cookies in your web browser to use the Service.

18. Mutual Warranty

Each Party warrants and represents that it has the right to enter into and perform its obligations under these Terms.

19. Indemnification

You agree to defend, indemnify and hold harmless Trialetics, its contractors, service providers, consultants, and their respective directors, employees, agents, partners and affiliates from and against any claims, damages, costs, liabilities and expenses (including reasonable attorneys' fees) arising out of or related to:

• Your use of the Service
• Your violation of these Terms
• Your violation of the rights of any third party

20. Disclaimer

21. Service Availability and Data Loss

22. Limitation of Liability

23. General Provisions