Pharvaris Clinical Trial Privacy Notice

1. Introduction and Scope

Pharvaris Netherlands B.V. and its affiliates (“Pharvaris”, “we”, “us”, “our”) takes the protection of personally identifiable information (“Personal Data”) very seriously. This Privacy Notice (this “Notice”) describes how we use your Personal Data, which we may receive directly from you or from third parties, in connection with the clinical trials we sponsor (each, a “Trial” and, together, “Trials”) and in the context of our compassionate use and expanded access programs (“Programs”).

This Notice is applicable to you if you are a Trial patient or a healthcare provider or other Trial personnel at one of our Trial sites (individually and together, “you,” “your”). This Notice does not apply to:

  • Personal Data we collect by other means, like Personal Data that we receive directly through our public website; or
  • Personal Data of Pharvaris employees.

Nothing in this Notice is intended to limit in any way your statutory rights, including your rights to a remedy or means of enforcement.

2. Controllership

Within the scope of this Notice, Pharvaris acts as a data controller for the Personal Data we collect, use, and process. This means that we determine the purposes and the means of the processing of Personal Data.

There may be other organizations that jointly control the processing of your Personal Data in conjunction with us. If you would like to know more about the other data controllers that jointly determine the purposes for processing your Personal Data, and the means by which it is done, you should ask your Trial doctor or Trial site for further details.

3. Categories Of Personal Data

Personal Data of Trial participants

We generally do not have direct access to Trial patients’ identifiable Personal Data, meaning that we are typically unable to directly identify Trial patients. Your Personal Data will be collected by the Trial site (the doctor’s office, clinic, hospital, or other healthcare facility where your Trial is being conducted) or other third parties, such as your primary care doctors. When any information relating to Trial patients is shared with us, it will be key-coded (also known as pseudonymized) so that you will not be identified by any direct personal identifier. This means that Trial personnel will replace identifying information like your name and contact information with a code number. Authorized personnel at the Trial site and some of the service providers listed in Section 9 below will in certain situations have direct access to directly identifying information like your name and date of birth.

In some cases, we will have access to directly identifying Personal Data during the Trial monitoring process and our monitors and personnel will temporarily have access to your unredacted medical records. During the monitoring process, the following types of Personal Data may be viewed and processed by us:

  • basic identifying information, such as your first and last name, year of birth, and age;
  • contact information, such as your phone number, physical address, and email address; and/or
  • health and healthcare information and medical records.

The following types of Personal Data may be processed in the context of our Trials and shared directly with us:

  • demographics such as:
    • the month/year of birth (or age at time of initial diagnosis and age at time of each recurrence);
    • information on your sex (male/female), race, ethnicity; and
    • country where patients received treatment at initial diagnosis.
  • location information, such as the location of your testing site and Trial location (i.e. study site);
  • healthcare information, such as the identity and contact information of your doctors and healthcare providers;
  • health information, such as your medical history (i.e. disease characteristics, surgical history, radiation history, treatment history, imaging data and radiography assessments);
  • current health status and reaction to the Trial drug or treatment; and/or
  • your genetic information related to your medical condition under investigation in the Trial.

You can ask your study doctor if you are unsure whether or not any specific Personal Data that you are being asked to provide is required as part of your participation in the Trial.

Personal Data of Participants in Programs

We may process the following types of Personal Data about individuals that participate in our Programs:

  • clinical trial subject identification number;
  • date of birth;
  • diagnosis (medical condition);
  • age;
  • sex;
  • country of residence;
  • treatment information;
  • dosage information.

Personal Data of Healthcare Providers and Trial Personnel

If you are a healthcare provider or other personnel working at one of our Trial sites, we may process the following types of Personal Data about healthcare providers in the context of our Trials:

  • your personal details, such as your name, age, gender, and contact details;
  • contact information, such as your phone number, work address, and email address;
  • professional and employment related information, such as your qualifications and job titles; and/or
  • location information, such as the location of your testing site and Trial location (i.e., study site).

Personal Data of Treating Physicians

We may process the following types of Personal Data about physicians treating patients that are enrolled in a Program:

  • basic identifying information, such as first and last name;
  • contact information, such as phone number, physical address and email address;
  • professional and employment related information, such as medical license number;
  • treatment center or medical institution;
  • physical address;
  • country.

4. How We Receive Personal Data

We may receive your Personal Data when:

  • you provide it to us, a Trial site, or one of our service providers directly;
  • you visit one of our Trial-specific websites or online portals;
  • your doctors or healthcare providers or healthcare personnel at a Trial site provide it to us; or
  • you or your employer provide it to us in your role as Trial personnel in the context of assisting in the operation of a Trial.

5. Purposes of Processing

Trial participants

To the extent permitted in Trial patients’ country or region, we will process their Personal Data for the purposes of:

  • conducting, managing, and facilitating your Trial;
  • determining your eligibility for a Trial;
  • enabling your participation in your Trial;
  • answering the research questions for the Trial and aggregating data to generate statistics relating to your Trial and/or study drug or health treatment;
  • arranging for the delivery of drugs to you and collection of unused drugs from you in relation to your Trial;
  • arranging your transportation to or from the Trial site;
  • sending you reminders about your appointments at your Trial site, or to take your medication on time;
  • monitoring and reporting on any adverse events, such as negative side effects;
  • providing compensation for Trial-related injuries;
  • developing new medicinal drugs or health treatments;
  • ensuring that each Trial drug is safe and reliable;
  • conducting related scientific and medical research;
  • complying with legislation governing Trials;
  • disclosing your Personal Data to the appropriate regulatory authorities, auditors, and ethics committees, if required by law;
  • responding to your inquiries and requests;
  • communicating with you on the status of your Trial; and
  • assigning a unique patient identification number if you are participating in a Trial.

We also process your Personal Data for the specific purposes described in the informed consent form, information sheet, and other Trial information provided to Trial patients by the Trial site.

Program Participants and their Treating Physicians

To the extent permitted in their country or region, we will process Personal Data of participants in Programs and their treating physicians for the purposes of:

  • administering and managing a Program;
  • enrolling patients in a Program;
  • providing medicinal drugs, health treatments, or products as part of a Program;
  • obtaining, analyzing, and reporting information on Program participation;
  • tracking patient progress/outcomes in a Program;
  • complying with our legal obligation to validate each patient, to carry out import license checks, and to otherwise comply with our regulatory responsibilities in the context of a Program.

Healthcare Providers and Trial Personnel

If you are a healthcare provider or other personnel at a Trial site, we will process your Personal Data for the purposes of:

  • managing our relationship with you and your employer;
  • contacting you and your employer for planning and organizing the Trials;
  • conducting the Trials; and
  • complying with applicable laws and regulations.

6. Basis of Processing

Before, during, and after each Trial, we will process your Personal Data for various purposes. In each case, we will rely on an appropriate lawful basis for processing your Personal Data. We will only process your sensitive Personal Data (like health and genetic data) when allowed by law.

Trial Participants and Program Participants:

We process your Personal Data for safety and reliability purposes in order to comply with our legal obligations. We also process your Personal Data for scientific research purposes based on our legitimate interest in conducting clinical trials, performing valuable scientific and medical research and administering Programs. If we process your Personal Data for other purposes after the end of a Trial or Program, we will do so based on your consent or our legitimate interest in conducting further research.

Pharvaris will need to process data about your health in order for you to participate in a Trial or Program. Health data is considered sensitive Personal Data (also known as a “special category” of Personal Data) and special rules apply to working with it. When we process special categories of your Personal Data, we only do so when the processing is necessary for reasons of public interest in the area of public health. Those reasons include making sure our drugs are safe and effective, and conducting our Trials safely. We also process your sensitive Personal Data based on your explicit consent.

The specific grounds on which we process your Personal Data, including your health data, may vary somewhat from the above in order to comply with the requirements of applicable local laws in jurisdictions where we sponsor Trials or operate Programs. If you are a participant in a Pharvaris Trial or Program, please refer to the informed consent form you signed for more information about the legal grounds on which we process your Personal Data. If there is any conflict between any provision in this Notice and any provision in the informed consent form you signed in connection with your participation in a Trial or Program, the informed consent form will control.

Where we process your Personal Data based on your consent, you may withdraw your consent at any time. However, this will not affect the lawfulness of our processing before you withdrew your consent. It will also not affect processing performed on other lawful grounds. If you withdraw your consent, you may be ineligible to continue participating in your Trial.

Trial Personnel and Treating Physicians of Program Participants:

Pharvaris may process your Personal Data based on our legitimate interests in facilitating the operation of our business and conducting Trials, operating our Programs, making informed investigator selection decisions, and improving our principal investigator and Trial staff recruiting and contracting processes.

We also process Personal Data because it is necessary for the performance of the contracts between Pharvaris and Trial sites, including by enabling us to communicate with you and other principal investigators about the performance of the relevant Trial.

Pharvaris may process your Personal Data in order to comply with applicable laws and regulations, including clinical trial regulations requiring us and those acting on our behalf to collect Personal Data from individuals who participate in the conduct of a Trial.

Your Personal Data may also be processed based on your consent. Where we process your Personal Data based on your consent, you may withdraw your consent at any time. However, this will not affect the lawfulness of our processing before you withdrew your consent. It will also not affect processing performed on other lawful grounds.

7. Automated Individual Decision-Making

If you participate in a Trial, you will be assigned a unique patient identification number. Depending on the Trial you participate in, this number may be used as part of an automatic process that randomly determines if you will receive the experimental drug substance or treatment that is being evaluated in the Trial, or if you will receive a different treatment. This type of automated decision-making is required in order to ensure that the Trial is conducted in an ethical way, and in accordance with good clinical practice standards.

8. Data Retention

Pharvaris will keep your Personal Data until we fulfill the purposes listed above, or for as long as required by applicable law.

Our Trials are long-term. We use them to track the effects of test medications using information collected from Trial participants, which also necessitates tracking the Trial personnel involved in the appliable Trial. This means we will need to keep your Personal Data for a long time.

To the maximum extent permitted by law, once your data has been key-coded and recorded in official Trial documents, we cannot remove it without affecting the accuracy of the studies and test results. For example, European law requires us to keep Personal Data that is part of the clinical trial master file for at least twenty-five years after the conclusion of the applicable Trial. Other laws may require different retention periods. This includes your identity and health information and any adverse effects of the drug you took during the Trial.

9. Sharing Personal Data With Third Parties

We will share your Personal Data with service providers who process Personal Data on our behalf and who agree to use your Personal Data only to assist us in conducting our Trials or as required by applicable law. These service providers include:

  • contract/clinical research organization services;
  • services relating to the preparation and submission of reports/documents to regulatory authorities;
  • patient recruitment services;
  • pathology laboratories;
  • clinical pharmacology service providers;
  • laboratory service providers;
  • data management and biostatistics service providers;
  • quality assurance, safety and pharmacovigilance software, and related services;
  • data storage and archiving software and related services;
  • trial oversight, imaging and digital patient services service providers;
  • data analytics and reporting software and services;
  • services related to the collection, storage, testing, and transportation of biological material;
  • providers of software that randomly decides which dose level or treatment you will receive during your Trial;
  • services related to the delivery, transportation or collection of study drug during your Trial;
  • services for managing drug distribution to Program participants and their treating physicians;
  • home healthcare services;
  • logistics and transport service providers; and
  • electronic data capture software and hardware providers.

We may also share the Personal Data with medical offices, and public government agencies, for the purpose of conducting our Trials and complying with applicable laws and research standards, and with our corporate affiliates, partners, licensees, and third party collaborators, who may continue or assist with further research and development of the products. Some of these third parties are data controllers in their own right and may be located in other countries.

10. International Transfers of Personal Data

Pharvaris and some of the third parties that process Personal Data on our behalf may be located in countries outside of the European Economic Area. In some cases, the relevant authorities may not have determined that those countries’ data protection laws provide a level of protection for your Personal Data. We will only transfer your personal data to third parties in these countries when proper safeguards are in place. Such safeguards include the European Commission approved standard contractual data protection clauses and appropriate technical, contractual, and organizational supplemental measures to ensure the safety of the personal data.

11. Other Disclosure of Your Personal Data

We may disclose your Personal Data:

  • to the extent necessary, to regulators, courts or competent authorities, to comply with applicable laws, regulations and rules (including, without limitation, federal, state or local laws), and requests of law enforcement, regulatory and other governmental agencies or if required to do so by court order;
  • with governmental, tax, regulatory or similar authorities (for example, customs or medicines and health products safety agencies) if you are a Program participant or their treating physician;
  • if, in the future, we sell or transfer, or we consider selling or transferring, part or all of our company, business, shares or assets to a third party, we will disclose your Personal Data to such third party (whether actual or potential) in connection with the foregoing events; or
  • in the event that we are acquired by, or merged with, a third-party entity, or in the event of bankruptcy or a comparable event, we reserve the right to transfer, disclose or assign your Personal Data in connection with the foregoing events; and/or
  • if necessary, to our group companies for business purposes, as described above.

If we have to disclose your Personal Data to a government or law enforcement authority, we may not be able to ensure that those officials will maintain the privacy and security of your Personal Data.

12. Cookies

A “cookie” is a small file stored on your device that contains information about your device. We may use cookies on our Trial-specific websites. For more information about the cookies we use, please refer to the cookie policy located in the footer of the website relevant to your specific Trial.

13. Data Integrity & Security

We have put in place technical, administrative, and physical measures that are designed to help protect your Personal Data from being accessed, disclosed, altered, or destroyed by unauthorized people. These measures include the use of measures like key-coding and encryption, where appropriate.

14. Your Rights

If we process your or your child’s Personal Data, you will have the right to request access to (or to update or correct) that Personal Data. You may also have the right to ask that we limit our processing of your Personal Data, to delete your Personal Data, and the right to object to our processing of your Personal Data. You may also have the right to data portability, which means that you may have the right to ask us to provide you with a copy of your Personal Data that another company like Pharvaris can process.

To submit these requests or raise any other questions, please contact us by using the information in the “Contact Us” section below.

If the EU or UK General Data Protection Regulation applies to our processing of your Personal Data, you have the right to lodge a complaint with a supervisory authority if you are not satisfied with how we process your Personal Data. Specifically, you can lodge a complaint in the Member State of the European Union of your habitual residence, place of work, or the alleged violation of the GDPR. In the UK, you can lodge a complaint with the UK Information Commissioner’s Office.

15. Data About Children

We obtain consent from a parent or legal guardian before processing Personal Data about children.

16. Changes To This Notice

If we change this Notice, we will provide you with a copy of the revised Notice or update the web page you read it on. We will also update the “Effective” date.

17. Contact Us

If you are a Trial participant and you have any questions about our processing of your Personal Data, please first speak with your study doctor. If we collected your Personal Data in any other context (e.g. if you are a healthcare provider, business contact or website visitor), you can contact us by emailing dataprivacyofficer@pharvaris.com. You may also contact our Data Protection Officer (“DPO”) directly using the contact details listed in Section 18 below.

Upon receipt of your request, please allow up to one month for us to reply.

18. Data Protection Officer

We have appointed VeraSafe as our DPO. While you may contact us directly, VeraSafe can also be contacted on matters related to the processing of Personal Data. VeraSafe’s contact details are:

VeraSafe
100 M Street S.E., Suite 600
Washington, D.C. 20003
Email: dataprivacyofficer@pharvaris.com
Web: https://www.verasafe.com/about-verasafe/contact-us/
Tell: +1-617-398-7067

19. United Kingdom Representative

We have appointed VeraSafe United Kingdom Ltd. as our representative in the United Kingdom for data protection matters. You can contact VeraSafe using the following details:

7 Albert Embankment
London SE1 7TL
United Kingdom
Phone: +44 (20) 4532 2003

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