IRT Privacy Policy and
Terms of Use

 

 

SUVODA IRT PRIVACY POLICY AND TERMS OF USE

These Terms of Use (“Terms”) explain the terms and conditions to which you agree if you access or use Suvoda IRT (“IRT” or "Service"), a randomization and drug supply management system, provided by Suvoda LLC (“Suvoda”, “We”, “Our”). The Terms also explain what information we collect from you, how we use it, and to whom we disclose it as well as what choices you may have in connection with this collection, use and sharing of information. By accessing or using the Service, you agree to be bound by these Terms. If you do not agree, please immediately discontinue accessing the Service. These Terms do not govern use of the www.suvoda.com website. Those terms may be found at http://www.suvoda.com/privacy-policy. 

User Conduct

In using the Service, you agree:

  • To use the Service only for the performance of your duties and only to the extent you are authorized;
  • Not to attempt to access any part of the Service which you are not authorized to access;
  • Not to disrupt or interfere with the security of, or otherwise abuse, the Service, system resources, accounts, servers, or networks connected to or accessible through the Service;
  • 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 Service;
  • To keep your user name and password confidential and not to allow any unauthorized user to access the Service using your account;
  • Not to upload, post, or otherwise transmit through or on the Service 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 Service or otherwise distribute in any way any content on the Service other than subject to our prior written permission;
  • Not to modify, store, copy, distribute, transmit, display, perform, reproduce, publish, license, transfer, post, translate or scrape any content without our prior written permission.

In connection with the relevant trial or study ("Study") subjects whose information you are accessing or amending using the Service, you represent and warrant that:

  • You have acquired, from or with respect to, each Study subject whose information you enter into the Service, adequate written consent 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);
  • You have acquired, from each Study subject who may receive text messages in connection with the Study, written consent to receive such messages in the form provided to you by the sponsor of the Study (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 telephone number to which text messages should no longer be sent, whether because (i) the intended recipient of the message is not the current subscriber or customary user of the telephone number; (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:  

When you use the Service we collect and store the following information:

Registration Information:
In order to use our Service, you will need to open an account. To do this you will need to choose a user name 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, and time zone.

Usage Information:
We collect and maintain information about your usage of the Service, including any actions you take in connection with the trials and studies to which you have access. For example:

  • Entering new subjects for the trial
  • Registering subject visits as complete
  • Dispensing drug to subjects
  • Marking drug shipments as "received"
  • Updating drug inventory status
  • Updating drug supply settings
  • Updating study settings

How We Use and Share the Information Collected:

We send the information you provide to us when you register to the Sponsor, and, following approval by the Sponsor, you will be able to access the Service. We may use the email address that you provide in order to supply you with information regarding our Service and communicate with you with respect to your use of the Service, including any maintenance issues and notifications with respect to our Terms.

We may also 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.

Audit Trail
Your activities in the Service will be labeled with your username, first name, and last name, and will be associated with you to track your activities in the Service (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 and/or pursuant to a regulatory requirement.

 

Other Sharing
In addition to the uses described above, we may also share your 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 Service
  • 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 mandatory applicable law
  • If we believe it is necessary in order to investigate, prevent, or take action regarding illegal activities, fraud, or situations involving potential threats to the rights, property, or personal safety of any person
  • 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 Service 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 Service generally)
  • To prevent or detect fraud or to address technical issues
  • 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 Service

Security and Information Protection

We take reasonable precautions to protect your personal information. For example, all personal information entered into the Service collected by us is transferred over https, and kept on a server in a secure environment within an ISO/IEC 27001 certifed data center. We limit access to personal information only to employees, our partners and any sub-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 personal information will always remain private when you use the Service.

Changing or Deleting Your Information

You may access your account with us to view or correct the personal information you provided to us and which is associated with your account.

If you wish to delete 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 your account, you will no longer be able to access the Service.

We may retain your information in an identifiable manner for as long as necessary to provide the Service, for as long as required by applicable laws and regulations 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 or contractual obligations.

Even if you have requested that we delete your personal information, keep in mind that the deletion by our third party providers, for example, of information stored in back-up, may not be immediate and will be deleted in accordance with the deletion cycle.

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

Cross Border Transfer

Suvoda transfers, processes, and stores information about you on servers located in a number of countries, including the United States. 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. Privacy Shield Framework and the Swiss-U.S. Privacy Shield Framework ("Privacy Shield") regarding the processing of all personal information ("personal data") it receives from the European Economic Area (EEA) member countries in reliance on the Privacy Shield. You can visit our Privacy Shield certificate https://www.privacyshield.gov/list. You can learn more about the Privacy Shield Framework, by visiting the Privacy Shield website https://www.privacyshield.gov/welcome.

When we receive personal information under the Privacy Shield 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 Privacy Shield Principles unless we are not responsible for the event giving rise to any alleged damage.

Under the Privacy Shield 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 Privacy Shield Principles. You may access, amend, correct or delete your registration information by accessing your account on the Service. You may also exercise this right by contacting us at privacy@suvoda.com.

With respect to personal information received or transferred pursuant to Privacy Shield, 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 Share the Information Collected" section above.

If you have any concerns or complaints regarding the processing of your personal information, please contact us as described in the "Complaints, Questions or Comments" Section below. You also have the option to resolve any dispute we have not adequately addressed through the Better Business Bureau our U.S.-based third party dispute resolution provider, at no cost to you. You may contact them through http://www.bbb.org/EU-privacy-shield/for-eu-consumers.

Under certain conditions, Privacy Shield provides the right to invoke binding arbitration when other dispute resolution procedures have not provided resolution. This is described in Annex I to the Privacy Shield [https://www.privacyshield.gov/article?id=ANNEX-I-introduction]

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 Service 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: 15-Dec-2017