SUVODA PRODUCT PRIVACY POLICY AND TERMS OF USE

Suvoda LLC, a U.S. company with corporate domicile at 181 Washington Street, Suite 100, Conshohocken, PA 19428, USA, and its subsidiaries (hereinafter collectively referred to as “Suvoda”, “We”, “Our”) provides clinical trial software products including, without limitation, Suvoda’s interactive response technology (IRT), Drug Inventory Management System (DIMS), electronic informed consent (eConsent) and electronic clinical outcomes assessment (eCOA), and related services (our "Services"). In the course of providing the Services We collect and process information about our clients, users of our Services and clinical trial data subjects and/or the caregivers of clinical trial data subjects. Some of such information is personal information, and could be related to an identified or identifiable natural person (the "Personal Information"). This privacy policy and terms of use (the "Terms") explains how and what We, as data controller, collect, use, share and protect such Personal Information about you as someone who uses the Services. It also explains the terms and conditions to which you agree if you access or use the Services as well as what choices you may have in connection with this collection, use and sharing of information. These Terms do not govern use of the www.suvoda.com website. Those terms may be found at http://www.suvoda.com/privacy-policy.

By using the Services you are hereby informed of the scope of these Terms. We encourage you to read them carefully.

By accessing or using the Services, you agree to be bound by these Terms. If you do not agree, please immediately discontinue accessing the Services.

User Conduct

In using the Services, you agree:

  • To use any device, SIM card or other hardware provided in connection with the Services (collectively, the “Hardware”) and the Services only as intended in the performance of your duties and only to the extent you are authorized;
  • Not to attempt to access any part of the Services which you are not authorized to access or to circumvent any use restrictions put into place to prevent certain uses of the Services or Hardware;
  • Not to disrupt or interfere with the security of, or otherwise abuse, the Services, system resources, accounts, servers, or networks connected to or accessible through the Services;
  • Not to use or attempt to use or access another person’s account or Personal Information, or create or use a false identity on the Services;
  • To keep your username and password confidential and not to allow any unauthorized user to access the Services using your account;
  • Not to upload, post, or otherwise transmit through or on the Services any viruses or other harmful, disruptive, or destructive files;
  • Not to decompile, reverse engineer, reverse assemble, decipher, or otherwise attempt to discover any programming code or any source code used in or with the Services or Hardware or otherwise distribute in any way any content on the Services or Hardware;
  • Not to modify, store, copy, distribute, transmit, display, perform, reproduce, publish, license, transfer, post, translate or scrape any content without our prior written permission.
  • You do not own any Hardware or any intellectual property therein or related thereto. You will take reasonable care to safeguard all Hardware and return it in good working condition as directed by the sponsor (the “Sponsor”) of the relevant trial or study (the “Study”), normal wear and tear excepted. Suvoda and/or Suvoda’s licensors remain the sole owner of all rights, title, and interest in the Services. Except as stated in these Terms, Suvoda does not grant you any rights to patents, copyrights, trade secrets, trademarks, or any other rights in respect to the items in the Services or Hardware. Suvoda reserves all rights not granted under these Terms.
  • To observe and comply with all Applicable Laws, Codes of Practice and any instructions or conditions notified to you by Suvoda or the Sponsor. “Applicable Laws” means local, national and international legislation, enactment, subordinate legislation, rule, regulation, order, directive or other provision, or requirement of a regulatory authority (or persons authorized on their behalf) and any judicial or administrative interpretation or application thereof, which has, in each case, the force of law in the jurisdictions in which the Services are provided and/or utilized. “Codes of Practice” means all guidelines governing use or provision of mobile telecommunications and data services that are issued by any generally recognized bodies or that are adopted by Suvoda or its third party providers from time to time.
  • Not to act or omit to act in any way in connection with your use of the Services which will or may place Suvoda or any other third party in breach of any provisions of Applicable Law or a Code of Practice, any other licenses, authorizations, and to cooperate fully with Suvoda and its third party providers to enable them to comply with all of the same.
  • Not to use the Services for any improper or unlawful purpose.
  • Not act or omit to act in any way which will or may injure or damage any persons or the property of any persons or howsoever cause the quality of the Services to be impaired.
  • To contact Suvoda’s support desk for support with the Hardware or Services (rather than the Hardware manufacturer or licensor, or network or other provider). The contact information for Suvoda’s support desk can be found at: https://www.suvoda.com/contact.
  • Suvoda may restrict or remove your access to the Services and use of the Hardware at any time.

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

  • You have acquired the adequate written consent, or confirmed that the data subject has adequately so consented, from or with respect to, each data subject whose information you enter into the Services, with respect to the processing of this information by Suvoda, including without limitation, the transfer of this information outside of the European Economic Area (EEA), the United Kingdom and Switzerland;
  • You have acquired from each data subject (or caregiver of a data subject, if applicable) who may receive email or other electronic means of communication in connection with the Study, written consent to receive such messages in the form provided to you by the Sponsor; and
  • You will notify us, immediately but within not later than one (1) business day after you become aware of such fact, of any email address or other contact information to which messages should no longer be sent, whether because (i) the intended recipient of the message is not the customary user of the email address; (ii) the recipient of the message indicates, in any manner, a desire to not be contacted; or (iii) for any other reason.

Information We Collect:

These Terms apply to Personal Information that We collect and process from you when you use the Services, including the following information:

Registration Information:

In order to use our Services, you will need to open an account. To do this you will need to choose a username and password. You will also need to provide your first and last name and email address. In some cases you will also need to provide 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 Services, including any actions you take in connection with the Studies to which you have access. For example:

  • 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 drug to data subjects
  • Marking drug shipments as "received"
  • Updating drug inventory status
  • Updating drug supply settings
  • Updating Study settings
  • Preparing Hardware to be used in a Study
  • Confirming that Hardware is being used in the proper jurisdiction and/or location

Additionally, Suvoda may provide information regarding the use of any Hardware to third parties as needed in order to provide the Services and/or Hardware, including without limitation, 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, and, following approval by the Sponsor, when you access the Services or Hardware. We may use the email address and/or phone number that you provide in order to supply you with information regarding our Services and communicate with you with respect to your use of the Services, including any maintenance issues and notifications with respect to our Terms, as well as to solicit feedback about our Services and to send you promotional materials about our Services. We may also use information about your use of the Services to improve the Services.

In addition, We may use the email address that you provide to send you notifications related to the Study you are accessing. These notifications are sent at the request of the Sponsor. If you wish to discontinue receiving those notifications, please contact the Sponsor directly.

If Hardware is part of the Services, We may share your name and the contact information that you provide us with third parties in order to send you the Hardware that is to be used in a Study.

Purpose of the Use of Information:

In addition to the above, Suvoda may use the information it collects, including Personal Information, for the following purposes:

  • To provide the Services to clients, users of our Services and clinical trial data subjects and/or the caregivers of clinical trial data subjects, as applicable, to fulfill our contractual responsibilities, and to comply with regulatory requirements;
  • To contact clients, users of our Services and clinical trial data subjects and/or the caregivers of clinical trial data subjects by phone, mail, email, and other electronic means of communication, as applicable, regarding the Services;
  • To send business communications, including by electronic means such as emails, regarding other products and Services for which clients may have interest;
  • To present targeted advertising;
  • For the specific purpose for which the information was provided;
  • To provide client-related Services to clients and users of our Services (to diagnose a problem related to our Services or to help manage this site);
  • To help improve the Services;
  • To prevent or detect fraud;
  • To fulfill the Terms of Use (http://www.suvoda.com/terms-of-use) (including protecting the rights, assets, and safety of Suvoda, its users, and others as well as protecting the content of the Services protected by copyrights);
  • To comply with laws and regulations or to meet the requirements of government authorities; and
  • To analyze use of the Services.

Audit Trail

Your activities in the Services will be labeled with your username, first name, and last name, and will be associated with you to track your activities in the Services (the "Audit Trail"). This information will be retained by us even after your account is deleted or the Study on which you worked has been completed (please see the "Changing or Deleting your Information" section below). This information may be shared, along with other information in connection with the Study, with the Sponsor and/or other third parties, including regulatory authorities, as may be instructed by the Sponsor, to fulfill our contractual obligations and/or pursuant to a regulatory requirement.

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 of such information
  • 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 Services
  • To a service provider/contractor to perform functions and process your data, consistent with these Terms, in order to help us provide the Services
  • 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
  • Where We are legally required to do so, such as in response to court orders or legal process, or to establish, protect, or exercise our legal rights or to defend against legal claims or demands, or to comply with requirements of Applicable Law
  • If We believe it is necessary in order to investigate, prevent, or take action regarding illegal activities, fraud, situations involving 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 situations that involve abuse of the Services infrastructure or the Internet in general (such as voluminous spamming, denial of service attacks, or attempts to compromise the security of the website infrastructure or the Services generally)
  • To enforce these Terms and any other terms that you have agreed to, including to protect the rights, property, or safety of Suvoda, its users, or any other person, or the Services

Please see our Cookies Policy at https://www.suvoda.com/cookie-policy for information about the technologies that We and third parties use to collect information and to learn about options in connection with cookies.

Suvoda 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 a variety of appropriate technical and organizational measures. For example, all information, including Personal Information, entered into the Services collected by us is transferred over https, and kept on a server in a secure environment 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, including Personal Information, entered into the Services only to employees, our affiliates, partners and any contractors who need the information to perform a specific service. Please remember that the Internet is not a 100% secure medium for communication, and We cannot guarantee that your information, including Personal Information, will always remain private when you use the Services.

Changing or Deleting Your Information; Privacy Rights

If you want to exercise your privacy rights as a data subject including, without limitation, to access and/or request an update, correction or deletion of the Personal Information We may have collected from you, please write to us at privacy@suvoda.com. Please identify yourself in such communication and provide us with sufficient information so that We can properly verify your identity. If you make such a request, We will respond to you within a reasonable time and in any case within a period of one (1) month. In particular you may exercise the following rights, subject to the paragraphs below in this section:

  • access your Personal Information together with information about how and on what basis it is processed (to the extent that information is not set out in this notice)
  • rectify inaccurate Personal Information (including to have incomplete data completed)
  • erase your Personal Information in those circumstances where it is no longer necessary in relation to the purposes for which it was collected and there is no legal basis for Suvoda to retain it
  • restrict processing of your Personal Information
  • object to processing which has "legitimate interests" as its legal basis
  • object to "automated decision making"
  • obtain a portable copy of your Personal Information

If you wish to delete your Personal Information in your account, please contact the Sponsor of the Study. Upon instruction from the Sponsor, and subject to the paragraph below, We will proceed to delete Personal Information you have provided. If We delete such Personal Information, you will no longer be able to access the Services.

We may retain your information, including Personal Information, in an identifiable manner for as long as necessary to provide the Services, for as long as required by Applicable Laws and/or for as long as We reasonably believe that retaining the information 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 those cases, the Personal Information will be segregated to limit data processing and the Personal Information will be stored and retained to comply with the corresponding applicable legal, regulatory or contractual obligations.

Even if you have requested that We delete your Personal Information, keep in mind that the deletion of Personal Information 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 privacy@suvoda.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. Suvoda will not discriminate against you for exercising your legal rights.

Cross Border Transfer

Suvoda transfers, processes, and stores information about you on servers located in a number of countries, including the United States, which countries do not offer an equivalent level of protection on privacy matters that is offered in other territories such as the European Union. We may also subcontract processing to, or share your information with, third parties located in countries other than your home country.

Transfers of Information from the EEA

Suvoda complies with the EU-U.S. Data Privacy Framework program (“EU-U.S. DPF)”, the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. Data Privacy Framework program (“Swiss-U.S. DPF” and together with the EU-U.S. DPF, the “DPF”) as set forth by the U.S. Department of Commerce. Suvoda has certified to the U.S. Department of Commerce that it adheres to the EU-U.S. Data Privacy Framework Principles (“EU-U.S. DPF Principles”) with regard to the processing of personal data received from the European Union in reliance on the EU-U.S. DPF and from the United Kingdom (and Gibraltar) in reliance on the UK Extension to the EU-U.S. DPF. Suvoda has certified to the U.S. Department of Commerce that it adheres to the Swiss-U.S. Data Privacy Framework program principles (“Swiss-U.S. DPF Principles” and together with the EU-U.S. DPF Principles, the “DPF Principles”) with regard to the processing of personal data received from Switzerland in reliance on the Swiss-U.S. DPF. If there is any conflict between the terms in this privacy policy and the EU-U.S. DPF Principles and/or the Swiss-U.S. DPF Principles, the applicable DPF Principles shall govern. To learn more about the Data Privacy Framework program, and to view our certification, please visit https://www.dataprivacyframework.gov/. When We receive Personal Information under the DPF and then transfer it to third party service providers, We are liable for any processing of Personal Information by such third parties that is inconsistent with the DPF Principles unless We are not responsible for the event giving rise to any alleged damage.

Under the DPF you are entitled to access, correct, amend, or delete Personal Information about you that We hold where it is inaccurate, or has been processed in violation of the DPF Principles. You may access, amend, correct or delete your registration information by accessing your account on the Services. You may also exercise this right by contacting us at privacy@suvoda.com.

With respect to Personal Information received or transferred pursuant to the DPF, Suvoda is subject to the investigatory and enforcement powers of the U.S. Federal Trade Commission.

In certain situations, Suvoda may be required to disclose Personal Information in response to lawful requests by public authorities, including in order to meet national security or law enforcement requirements. For more information, please see the " How We Use and Share the Information Collected " section above.

In compliance with the EU-US DPF Principles, Suvoda commits to resolve complaints about your privacy and our collection or use of your personal information transferred to the United States pursuant to the DPF Principles. European Union, Swiss and United Kingdom individuals with DPF inquiries or complaints should first contact Suvoda at privacy@suvoda.com or as set forth under the section titled “Complaints, Questions or Comments” below.

Suvoda has further committed to refer unresolved privacy complaints under the DPF Principles to an independent dispute resolution mechanism, Data Privacy Framework Services, operated by BBB National Programs. If you do not receive timely acknowledgment of your complaint, or if your complaint is not satisfactorily addressed, please visit https://bbbprograms.org/programs/all-programs/dpf-consumers/ProcessForConsumers for more information and to file a complaint. This service is provided free of charge to you.

If your DPF complaint cannot be resolved through the above channels, under certain conditions, you may invoke binding arbitration for some residual claims not resolved by other redress mechanisms. See https://www.dataprivacyframework.gov/s/article/G-Arbitration-Procedures-dpf?tabset-35584=2

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 may not provide the same 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 Services you are consenting to this transfer of your Personal Information.

Changes to These Terms

These Terms are subject to revisions from time to time, in our sole discretion. When We make changes We deem material We will provide you with prominent notice as appropriate under the circumstances, and you will be notified of such changes on your next log in to the system. Your continued use of the Services or Hardware after the changes have been made will constitute your acceptance of the changes. Please therefore make sure you read any such notice carefully. If you do not wish to continue using the Services under the new version of these Terms, please cease using the Services.

Complaints, Questions or Comments

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

Suvoda LLC
181 Washington Street, Suite 100
Conshohocken, PA 19428
ATTN: Privacy Officer
Phone: 1-855-788-6321
Email: privacy@suvoda.com

Suvoda SRL
10 Bld I.C. Bratianu, Floor 3, District 3
Bucharest, Romania, 011413
ATTN: Privacy Officer
Phone: +40 (31) 2265529
Toll Free: 0800-896-362
Email: privacy@suvoda.com

 

Last updated: 9-October-2023