Privacy Policy and Terms of Use

Trialogics System Privacy Policy and Terms of Use

Trialogics LLC, a U.S. company with corporate address at 2 Mill Road, Suite 110, Wilmington, DE 19806, USA (hereinafter collectively referred to as “Trialogics”, “We”, “Our”) provides clinical trial software products including, without limitation, Trialogics interactive response technology (IRT), Remote Device Management, Supply Management, electronic informed consent (eConsent) and electronic clinical outcomes assessment (eCOA), and related services (our “Systems”). 

As we provide our Systems, we gather and process information about our clients, users, and clinical trial data subjects, as well as their caregivers. Some of this information is personal and pertains to identified or identifiable individuals (“Personal Information”). This privacy policy and terms of use (“Terms”) outline how we, as the data controller, collect, use, share, and protect your Personal Information when you use our Systems. Additionally, the Terms detail the conditions to which you agree upon accessing or using the Systems, and the options available to you regarding the collection, use, and sharing of your information. 

These Terms do not govern use of the www.trialogics.com website. Those terms may be found at https://www.trialogics.com/.

By using our Systems, you acknowledge and understand the scope of these Terms. We strongly recommend that you read them thoroughly. By accessing or utilizing the Systems, you agree to be bound by these Terms. If you do not agree, please discontinue using the Systems immediately.

User Conduct

By using the Systems, you agree to:

• Use any device, SIM card, or other hardware provided (collectively, the “Hardware”) and the Systems solely for your authorized duties.
• Not attempt to access unauthorized parts of the Systems or bypass usage restrictions.
• Refrain from disrupting or interfering with the security of the Systems, including system resources, accounts, servers, or networks.
• Avoid using or attempting to use another person’s account or Personal Information, or creating a false identity on the Systems.
• Keep your username and password confidential, and prevent unauthorized access to the Systems using your account.
• Not upload, post, or transmit any viruses or harmful files through the Systems.
• Refrain from decompiling, reverse engineering, deciphering, or attempting to discover any programming code or source code used in the Systems or Hardware.
• Not modify, store, copy, distribute, transmit, display, reproduce, publish, license, transfer, post, translate, or scrape any content without prior written permission.
• Understand that you do not own the Hardware or its intellectual property. You will take reasonable care to safeguard all Hardware and return it in good condition, except for normal wear and tear, as directed by the sponsor (the “Sponsor”) of the relevant trial or study (the “Study”). Trialogics and/or its licensors retain all rights, title, and interest in the Systems. Trialogics does not grant you any rights to patents, copyrights, trade secrets, trademarks, or any other rights in the Systems or Hardware. Trialogics reserves all rights not granted under these Terms.
• Observe and comply with all Applicable Laws, Codes of Practice, and any instructions or conditions notified by Trialogics or the Sponsor. “Applicable Laws” means local, national, and international legislation, enactments, rules, regulations, orders, directives, or requirements of regulatory authorities with the force of law. “Codes of Practice” refers to guidelines governing the use or provision of mobile telecommunications and data services issued by recognized bodies or adopted by Trialogics or its third-party providers.
• Not act or omit to act in ways that may place Trialogics or any third party in breach of any Applicable Law or Code of Practice, licenses, or authorizations, and cooperate fully with Trialogics and its third-party providers to ensure compliance.
• Not use the Systems for improper or unlawful purposes.
• Avoid actions or omissions that may injure or damage persons or property or impair the quality of the Systems.
• Contact Trialogics support desk for assistance with the Hardware or Systems, rather than the Hardware manufacturer or licensor, or network or other provider. Support contact information can be found at: Trialogics Support.
• Understand that Trialogics may restrict or remove your access to the Systems and use of the Hardware at any time.

In connection with the Study subjects whose information you are accessing or amending using the Systems, you represent and warrant that:

• You have obtained the necessary written consent, or confirmed that the data subject has provided adequate consent, for each data subject whose information you enter into the Systems. This consent includes, but is not limited to, the processing of this information by Trialogics and the transfer of this information outside of the European Economic Area (EEA), the United Kingdom, and Switzerland.
• You have obtained written consent from each data subject (or their caregiver, if applicable) to receive email or other electronic communications in connection with the Study, using the form provided by the Sponsor.
• You will promptly notify us, within one (1) business day, if any email address or other contact information should no longer receive messages. This may occur because (i) the intended recipient is no longer the primary user of the email address; (ii) the recipient indicates a desire not to be contacted; or (iii) for any other reason.
  

Information We Collect

These Terms apply to the Personal Information we collect and process when you use our Systems, which includes the following:

Registration Information

To use our Systems, you will need to open an account, which requires a username and password. You must also provide your first and last name and email address. In some cases, you will need to provide additional information such as your phone number, fax number, business address, time zone, title, and other business contact information.

Usage Information

We collect and maintain information about your usage of the Systems, including actions you take in connection with the Studies you have access to. Examples include:

• Entering new data subjects and/or caregivers for the Study
• Assigning electronic informed consent documents to data subjects and/or caregivers
• Signing electronic informed consent documents
• Completing eCOA assessments
• Registering data subject visits as complete
• Dispensing drugs to data subjects
• Marking drug shipments as “received”
• Updating drug inventory status
• Updating drug supply settings
• Updating Study settings
• Preparing Hardware for use in a Study
• Confirming that Hardware is used in the proper jurisdiction and/or location

Trialogics may also provide information regarding the use of any Hardware to third parties as needed to provide the Systems and/or Hardware. This includes browsing history, software and settings of the Hardware, and information generated by the Hardware.

How We Use and Share the Information Collected

We send the information, including Personal Information, you provide to us when you register to the Sponsor. Upon approval by the Sponsor, we use this information to grant you access to the Systems or Hardware. We may use the email address and/or phone number you provide to supply you with information about our Systems, communicate with you regarding your use of the Systems, address maintenance issues, notify you of updates to our Terms, solicit feedback, and send promotional materials. Additionally, we may use information about your usage to improve the Systems.

We may use the email address you provide to send notifications related to the Study you are accessing, at the request of the Sponsor. If you wish to discontinue receiving such notifications, please contact the Sponsor directly. If Hardware is part of the Systems, we may share your name and contact information with third parties to send you the Hardware for use in a Study.

Purpose of the Use of Information

Trialogics may use the information it collects, including Personal Information, for the following purposes:

• To provide the Systems to clients, users, and clinical trial data subjects and/or their caregivers, as applicable, to fulfill contractual responsibilities and comply with regulatory requirements
• To contact clients, users, and clinical trial data subjects and/or their caregivers by phone, mail, email, and other electronic means regarding the Systems
• To send business communications, including electronic communications, about other products and Systems of interest to clients
• To present targeted advertising
• For the specific purpose for which the information was provided
• To provide client-related Systems to diagnose problems or manage this site
• To improve the Systems
• To prevent or detect fraud
• To fulfill the Terms of Use (https://www.trialogics.com/), including protecting the rights, assets, and safety of Trialogics, its users, and others, as well as protecting copyright-protected content on the Systems
• To comply with laws and regulations or meet government authority requirements
• To analyze usage of the Systems

Audit Trail

Your activities in the Systems will be labeled with your username, first name, and last name, and will be associated with you to track your activities in the Systems (the “Audit Trail”). This information will be retained by us even after your account is deleted or the Study you worked on is completed (please refer to the “Changing or Deleting Your Information” section below). This information may be shared with the Sponsor and/or other third parties, including regulatory authorities, as instructed by the Sponsor, to fulfill our contractual obligations and/or meet regulatory requirements.

Other Sharing

In addition to the uses described above, we may also share your information, including Personal Information, with third parties for the following purposes:

• When you consent to the disclosure
• In conjunction with an audit by the FDA or other regulatory agency
• To a parent company, subsidiary, joint venture, or other company under common control with us for the provision of the Systems
• To a service provider/contractor to perform functions and process your data consistent with these Terms to help us provide the Systems
• In connection with a merger, acquisition, consolidation, change of control, or sale of all or a portion of our assets, or if we undergo bankruptcy or liquidation
• When legally required, such as in response to court orders or legal processes, or to establish, protect, or exercise our legal rights, defend against legal claims, or comply with requirements of Applicable Law
• If we believe it is necessary to investigate, prevent, or take action regarding illegal activities, fraud, potential threats to the rights, property, or personal safety of any person, or to address technical issues
• In an emergency or to protect the safety of any person
• If we believe it is necessary to investigate, prevent, or take action regarding abuse of the Systems infrastructure or the Internet, such as voluminous spamming, denial of service attacks, or attempts to compromise the security of the website infrastructure or the Systems
• To enforce these Terms and any other terms you have agreed to, including to protect the rights, property, or safety of Trialogics, its users, any other person, or the Systems

Cookies Policy

For information about the technologies we and third parties use to collect information and to learn about options in connection with cookies, please see our Cookies Policy. Trialogics will not sell or rent your Personal Information.

Security and Information Protection

We take reasonable precautions to protect all information, including your Personal Information, applying various technical and organizational measures. For example, all information entered into the Systems is transferred over https and kept on a secure server within an ISO/IEC 27001 certified data center, unless and until we need to share it with third parties as set forth above. We limit access to all information to employees, affiliates, partners, and contractors who need the information to perform a specific service. However, please remember that the Internet is not a 100% secure medium for communication, and we cannot guarantee that your information will always remain private when using the Systems.

Changing or Deleting Your Information; Privacy Rights

If you want to exercise your privacy rights as a data subject, including accessing, updating, correcting, or deleting the Personal Information we may have collected from you, please write to us at support@Trialogics.com. Please identify yourself and provide sufficient information so that we can verify your identity. We will respond within a reasonable time, typically within one (1) month. In particular, you may exercise the following rights:

• Access your Personal Information along with information about how and why it is processed
• Rectify inaccurate Personal Information, including completing incomplete data
• Erase your Personal Information when it is no longer necessary for the purposes for which it was collected, and there is no legal basis for Trialogics to retain it
• Restrict processing of your Personal Information
• Object to processing based on “legitimate interests”
• Object to “automated decision making”
• Obtain a portable copy of your Personal Information

If you wish to delete your Personal Information, please contact the Sponsor of the Study. Upon instruction from the Sponsor, and subject to the following paragraph, we will delete the Personal Information you provided. Note that if we delete such Personal Information, you will no longer be able to access the Systems.

We may retain your information, including Personal Information, in an identifiable manner for as long as necessary to provide the Systems, as required by Applicable Laws, or for as long as we reasonably believe it is necessary to protect our legal rights or legitimate business interests, or those of the Sponsor. We will retain the Audit Trail as necessary to fulfill our legal, regulatory, or contractual obligations. In such cases, the Personal Information will be segregated to limit data processing and stored to comply with corresponding legal, regulatory, or contractual obligations.

Even if you have requested that we delete your Personal Information, the deletion by our third-party providers may be performed in accordance with their internal policies and practices.

For any privacy or data protection-related questions, please write to support@trialogics.com.

California Privacy Rights

Under California laws, California residents have certain rights with respect to their Personal Information. They can request access to or deletion of their Personal Information by contacting the Sponsor. Trialogics will not discriminate against you for exercising your legal rights.

Cross Border Transfer

Trialogics transfers, processes, and stores information about you on servers located in various countries, including the United States, which may not offer the same level of privacy protection as your home country. We may also subcontract processing to, or share your information with, third parties in countries other than your home country.

Other Cross-Border Transfers

In connection with the cross-border transfer of your Personal Information, including to the United States, your Personal Information may be subject to privacy laws that do not provide the same level of protection as your country of residence. For example, government entities in the United States and other countries may have certain rights to access your Personal Information. By using the Systems, you consent to this transfer of your Personal Information.

Changes to These Terms

These Terms are subject to revisions from time to time at our sole discretion. When we make material changes, we will provide you with prominent notice as appropriate under the circumstances, and you will be notified of such changes upon your next login to the system. Your continued use of the Systems or Hardware after the changes have been made will constitute your acceptance of the changes. Therefore, please read any such notice carefully. If you do not wish to continue using the Systems under the new version of these Terms, please discontinue using the Systems.

Complaints, Questions or Comments

We welcome questions and comments about these Terms. Questions or comments should be directed to:

Trialogics LLC
2 Mill Rd, Suite 110
Wilmington, DE 19806
Tel: (302) 313-9000

Email: support@trialogics.com

The Trialogics EU Representative is:

Ametros Ltd
Unit 3D, North Point House,
North Point Business Park,
New Mallow Road, Cork, Ireland

Tel: +44 (0)330 223 2246

Email: gdpr@ametrosgroup.com

The Trialogics UK Representative is:

Ametros Group Ltd
Lakeside Offices,
Thorn Business Park,
Hereford, England. HR2 6JT

Tel: +44 (0)330 223 2246

Email: gdpr@ametrosgroup.com

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