Suvoda BYOD Product Privacy Policy and Terms of Use

SUVODA BYOD PRODUCT PRIVACY POLICY AND TERMS OF USE

Suvoda LLC, a U.S. company organized under the laws of Pennsylvania, USA, and its subsidiaries (hereinafter collectively referred to as “Suvoda”, “We”, “Our”) provides clinical trial software products and related services (collectively, “Services”) including, without limitation:

interactive response technology (IRT);
Drug Inventory Management System (DIMS);
electronic informed consent (eConsent);
electronic clinical outcomes assessment (eCOA); and
electronic patient portal (ePatient)

to pharmaceutical, biotechnology and medical device companies conducting clinical trials as well as contract research organizations and other companies involved in servicing clinical trials (collectively, “Suvoda’s Customers”). Suvoda’s Customers are the sponsors of clinical trials (each a “Sponsor” and collectively, “Sponsors”) or provide services on behalf of Sponsors.

Scope

This BYOD Privacy Policy and Terms of Use (“Terms”) applies to clinical trial participants and their caregivers who use Suvoda’s application containing eCOA and ePatient functionality (the “Suvoda Application”) on their own devices (and not on devices provided by Suvoda). You should review the privacy policy of the Sponsor and/or the consent document that you sign in connection with participating in the applicable clinical study (the “Study”) for further information on how Suvoda processes your Personal Information in connection with Suvoda’s Services other than providing the Suvoda Application.

In the course of making the Suvoda Application available to Suvoda’s Customers, Suvoda collects and processes information about users of the Suvoda Application. Some of such information is personal information that could be related to an identified or identifiable natural person (the "Personal Information").

You should stop using the Suvoda Application if you are not a clinical trial participant or the caregiver of a clinical trial participant, in either case, who is authorized to use the Suvoda Application by a Suvoda Customer.

Terms of Use

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

If you have questions about the Personal Information that Suvoda processes in connection with the Services or would like to update, correct, delete or exercise your rights in connection with the Personal Information we may have collected about you, please contact the Sponsor of the applicable clinical trial.

User Conduct

In using the Suvoda Application, you agree:

Not to attempt to access any part of the Suvoda Application which you are not authorized to access or to circumvent any use restrictions put into place to prevent certain uses of the Suvoda Application or the device you use to access the Suvoda Application (“Hardware”);
Not to disrupt or interfere with the security of, or otherwise abuse, the Suvoda Application, system resources, accounts, servers, or networks connected to or accessible through the Suvoda Application;
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 Suvoda Application;
To keep your credentials confidential and not to allow any unauthorized user to access the Suvoda Application using your credentials;
Not to upload, post, or otherwise transmit through or on the Suvoda Application 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 Suvoda Application or otherwise distribute in any way any content in the Suvoda Application;
Not to modify, store, copy, distribute, transmit, display, perform, reproduce, publish, license, transfer, post, translate or scrape any content without our prior written permission.
To observe and comply with all Applicable Laws and any instructions or conditions notified to you by Suvoda or Suvoda’s Customer. “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.
Not to act or omit to act in any way in connection with your use of the Suvoda Application which will or may place Suvoda or any other third party in breach of any provisions of Applicable Law, or any licenses or 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 Suvoda Application 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 Suvoda Application to be impaired.
To contact your clinical trial site (e.g. the hospital or clinician’s office where you enrolled in the clinical trial) for support with the Suvoda Application, rather than Suvoda.
Suvoda may restrict or remove your access to the Suvoda Application at any time.

Privacy Policy

This Privacy Policy covers the Personal Information that we process in our capacity as a service provider (processor) to Suvoda’s Customers in order for Suvoda’s Customers to facilitate the clinical trial and as necessary to provide the Services. In general, we process information that we receive in our capacity as a service provider for the purposes for which Suvoda Customer’s provided the information and subject to our contract with the particular Suvoda Customer.

If you are in the U.S., please note that in the course of providing Services, Suvoda processes Personal Information that may be exempt from U.S. state privacy laws and state consumer health laws, such as Personal Information that is collected as part of human subjects research pursuant to the good clinical practice guidelines issued by the international council for harmonization. Consequently, certain privacy obligations that otherwise would apply to Personal Information do not pertain to the data processed by Suvoda on behalf of Suvoda’s Customers.

Personal Information We Collect:

This Privacy Policy applies to Personal Information that We collect and process from you when you use the Suvoda Application, including the following information:

In order to use our Suvoda Application, you will need to open an account. To do this you will need to choose login credentials. You may also need to provide your email address, phone number, first and last name, address, time zone, health related information and, for Suvoda’s ePatient, your Social Security Number or other government identification number, banking information, and answers to security questions. In providing Suvoda’s ePatient, we may also process your clinical trial subject identification number, initials, home address, gender, date of birth and, for scheduling appointments, your calendar information.

Usage Information:

We collect and maintain information about your usage of the Suvoda Application, including any actions you take in connection with the Studies to which you have access. For example:

Entering your credentials and other Personal Information
Completing eCOA assessments
Submitting reimbursement requests and information related thereto
Scheduling appointments

Additionally, through your use of the Suvoda Application, Suvoda may receive information regarding your general geographic location (e.g. country), a de-identified device number, device battery level, time zone, local date and time, log-in attempts and other activity in the Suvoda Application and may share this information with the Suvoda Customer or Sponsor.

How We Use and Share the Information Collected:

We share certain of your Personal Information with Suvoda’s Customer. We may use the email address and/or phone number that you provided in order to supply you with information regarding our Services and communicate with you with respect to the Study or 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. We may also use information about your use of the Services to improve the Services.

We also share your Personal Information with third parties as needed to provide the Services including, with third parties whose software is integrated with Suvoda’s. You may be required to accept a privacy policy from one or more of these third parties to use the Services and in certain cases, you may be required to provide Personal Information directly to those third parties. In such cases, the privacy policies of those third parties will apply.

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 you and our Customers, to fulfill our contractual responsibilities, and to comply with legal and regulatory requirements;
To contact you regarding the Services;
For the specific purpose for which the information was provided;
To diagnose a problem related to our Services and to troubleshoot such problem or to help manage the Suvoda Application;
To help improve the Services;
To prevent or detect fraud;
To fulfill the Terms of Use set forth herein, 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 Suvoda Application will be labeled with your user identifier and will be associated with you to track certain of your activities in the Suvoda Application (the "Audit Trail"). This information will be retained by us even after your account is deleted or the Study in which you participated 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 Suvoda Customer, Sponsor and/or other third parties, including regulatory authorities, as may be instructed by the Sponsor or Suvoda Customer, 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 Suvoda’s Customer or 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 Suvoda’s Customer or 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 have implemented safeguards that are intended to protect the personal information we collect from loss, misuse, unauthorized access, disclosure, alteration, and destruction. Please be aware that despite our efforts, no data security measures can guarantee security.

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 your clinical site.

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 your clinical site 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 Suvoda Application 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 Suvoda Application under the new version of these Terms, please cease using the Suvoda Application.

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: 20-Sept-2024}