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This policy applies to all information processed by NewAmsterdam Pharma and/or Medpace relating to any identified or identifiable natural person visiting this website or participating in the PREVAIL study An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person (“Personal Data”).
NewAmsterdam Pharma and its contract research organisation (“CRO”) Medpace, Inc. (“Medpace”) respect the privacy of individuals of all nationalities in the processing of their Personal Data, recognising the fundamental rights to lawfulness, fairness, and transparency. We adhere to the principles of data privacy, including data minimisation. We adhere to laws relating to data protection in all jurisdictions in which we conduct business, including but not limited to the Privacy Act 1988 in Australia, the Health Insurance Portability and Accountability Act (“HIPAA”), the General Data Protection Regulation (EU) 2016/679 ("GDPR"), the California Consumer Protection Act (“CCPA”), and the United Kingdom Data Protection Act of 2018 and United Kingdom GDPR.
This website is not intended for, or designed to attract, children under the age of 16. No Personal Data should be submitted to us through the website by visitors who are less than 16 years old.
2.1.1 If you use our website, we may collect information about you, such as your IP address and location. We also may collect Personal Data if you submit an inquiry on our website.
2.1.2 The purpose of collecting this Personal Data is to inform the public of the PREVAIL study, to respond to you, to provide you with information that you have requested (which may relate to our products or services), or to communicate with you for other purposes which are requested by you in your inquiry. Such other purposes may include, from time to time, monitoring our regulatory compliance, and compiling profiles and personal information about you in order to identify suitable education/awareness programs or suitable opportunities to collaborate with you.
2.1.3 We will disclose your Personal Data within our company, and to our corporate affiliates who agree to treat it in accordance with this Privacy Policy. Personal Data also may be transferred to third parties who act for and on our behalf, for further processing in accordance with the purpose(s) for which the data were originally collected. These third parties have contracted with us to only use Personal Data for the agreed upon purposes and not to sell or disclose your Personal Data to third parties except as required by law, or as stated in this Privacy Policy.
2.1.4 In relation to the abovementioned activities you may have provided consent (for example for the use of cookies as set forth below) or we rely on the legal basis of legitimate interest. Our legitimate interest includes improving our website and communicating with our website visitors.
2.2.1 If you are a participant in a clinical trial that is sponsored by NewAmsterdam Pharma and managed by Medpace, we will collect Personal Data from you. This data may include coded (“pseudonymised”) medical and health information which is collected by investigators and their staff at the study sites.
2.2.2 We may transmit this data from the jurisdiction in which it was collected to NewAmsterdam Pharma at 1411 DC Naarden in The Netherlands and/or Medpace headquarters in the United States. When consent is required for the processing of Personal Data, the physician investigators overseeing the trial are responsible for ensuring that you understand and consent to the gathering of your Personal Data, including the transfer of such pseudonymised information to third parties who may be providing services for the clinical trial.
2.2.3 The purpose of collecting the Personal Data of clinical trial participants is to promote the global development of safe and effective medical therapeutics. We are committed to conducting clinical trials in a manner that strictly adheres to all national and international ethical requirements and clinical trial regulations. Effective adherence to clinical trial regulations requires the gathering, recording, processing, storing, and transmitting of personal data of clinical trial participants, clinical trial investigators, vendors, support staff, and employees.
2.2.4 Pursuant to Opinion 03/2019 of the European Data Protection Board, the processing of Personal Data of EU citizens participating in a clinical trial by a commercial entity is justified by on the one hand, the legal obligations of NewAmsterdam Pharma in relation to safety reporting, archiving and disclosure of trial data to competent authorities in relation to inspections. On the other hand, your Personal Data is processed based on the legitimate interest of NewAmsterdam Pharma offering high standard of research, transparency and sharing information with the hospitals that are involved in the performance of the study or services providers facilitating the performance of the study such as data management services, data analyses, etc. Specifically, the processing of sensitive categories of data is carried out for reasons of public interest in the area of public health, and/or archiving for scientific purposes in accordance with Article 89(1) of the GDPR.
Cookies are small text files that are stored on browsers or devices by websites, apps, online media, and advertisements. We use cookies and similar technologies for purposes such as:
Your web browser may be programmed to notify you when you are receiving a cookie, giving you the choice to accept it or not. You can also refuse all cookies by turning them off in your browser.
3.1.1 To enhance the user experience of our website, including internal operations necessary to provide our services, such as troubleshooting software bugs and operational problems; conducting website traffic data analysis, testing, and research; and to monitor and analyse usage and activity trends.
3.1.2 To respond to inquiries regarding our business or service.
3.1.3 We may use your Personal Data to investigate or address claims or disputes relating to our business, or as otherwise allowed by applicable law, or as requested by regulators, government entities, and official inquiries. Medpace may share your Personal Data if we believe it is required by applicable law, legal process or governmental request, or where the disclosure is otherwise appropriate due to safety or similar concerns. This includes sharing Personal Data with law enforcement officials, public health officials, other government authorities, or other third parties as necessary to enforce our Code of Conduct or other policies; to protect our rights or property; or the rights, safety, or property of others; or in the event of a claim or dispute relating to our business operations.
Personal Data collected for the purposes of hosting the website are maintained for the duration of the study, or longer as instructed by the Data Controller (NewAmsterdam Pharma). At the conclusion of the study, or as otherwise requested by the Data Controller, Personal Data is either anonymised or deleted.
3.5.1 The coded Personal Data collected from you during a clinical trial is used to test the safety and efficacy of experimental drugs and medical devices. If you are a participant in a clinical trial sponsored by NewAmsterdam Pharma and managed by Medpace, please review the informed consent form that you received from your study doctor for more information about how your Personal Data will be used and protected, with whom your Personal Data may be shared and for what purposes, but also for which period your Personal Data is retained.
4.1 We use physical, electronic and organisational procedures to safeguard and secure your Personal Data. This includes encryption, firewalls, access controls, and other procedures to protect Personal Data from loss, misuse, unauthorised access, disclosure, alteration, and destruction.
4.2 Personal Data is restricted to authorised individuals, who only can access it on a "need to know" basis.
4.3 We may store some business records or clinical trial documents in hard copy (paper or disk) format, as required by law or regulation, or pursuant to the fulfilment of a legitimate business purpose. In this case, documents are retained for the minimum time necessary, and then securely destroyed. Long-term storage of hard copy documents may be carried out by a qualified third-party vendor.
Your Personal Data may be shared with third parties to fulfill the purposes for which it was originally collected. Personal Data is transferred to third parties pursuant to contractual obligations consistent with Article 28(4) of GDPR when applicable, and with this Privacy Policy. Recipients of Personal Data may be regulatory authorities, ethical committees, and third parties associated with the study, the Institution where the study takes place, or the CRO and its Affiliated companies.
Your Personal Data may be transferred to a third country outside of the EU or European Economic Area, or to a country where data protections are not as strong as in your country. Please be aware that any personal data you provide to us will be transferred to, processed, and stored in the United States. You acknowledge to understand that your information, including personal information, is transferred to the United States as set forth in this Privacy Policy, by visiting our site or submitting an inquiry to us. Transfers to these countries are made using appropriate safeguards as outlined in Article 46 of the GDPR. Transfer of your coded Personal Data collected during the study to countries that may not offer adequate data protection pursuant to the GDPR and how we will protect your data, is outlined in the informed consent form made available to you by your physician.
6.1 We are committed to cooperating to the full extent of applicable law in the exercise of the rights of data participants. If you would like to exercise your rights under applicable data privacy law, or to inquire about the processing of your Personal Data by NewAmsterdam Pharma or Medpace, contact us pursuant to Section 8 of this Privacy Policy.
6.2 EU and Swiss citizens whose Personal Data is processed have a right to be informed of the choices and means available for limiting its use and disclosure. EU and Swiss citizens may have the right to access, modify, or suppress their Personal Data, to elect not to have Personal Data transferred to a third party, or to object to their Personal Data being used for any purpose materially different from that disclosed to them, or stated within this Privacy Policy. We will honour your request to access, modify, suppress, prevent or stop transferring, or delete your Personal Data to the extent reasonably possible. We may, pursuant to the law, disclose Personal Data in response to lawful requests by public authorities, including to meet national security or law enforcement requirements. Please note that pursuant to clinical trial regulations, some Personal Data may be retained even if you request that it be deleted.
6.3 If you are a clinical trial participant, you should first contact the study site at which you participated, or the Principal Investigator of the study, to enquire about your choices and the means available for limiting the use and disclosure of your Personal Data under applicable data privacy laws. The rights available to you as a clinical trial participant may be limited pursuant to an exception to the applicable data privacy law to preserve the integrity or scientific value of the clinical trial data that was collected.
7.1 If you are an EU resident, you have a right to lodge a complaint with the appropriate EU supervisory authority, and also a right to an effective judicial remedy against data controllers and processors.
7.2 Residents of California may have a private right of action in the event of a data breach. Pursuant to California law, affected individuals must first notify us of the alleged violation and provide us 30 days to cure the violation.
8.1 8.1 For more information about our commitment to protecting data privacy, or to exercise any rights you may have under applicable data privacy laws, please contact
8.1.1 NewAmsterdam Pharma at dpo@newamsterdampharma.com,
8.1.2 Medpace at privacy@medpace.com, by telephone at +1 (513) 579-9911 (Cincinnati local), +1 (800) 730-5779 (USA toll free) or by mail at 5375 Medpace Way, Cincinnati, Ohio 45227 United States of America, Attn: Data Protection Officer.
8.2 We may occasionally update this notice. If we make significant changes, we will notify users of the changes on our website, or through other means, such as email. We encourage users to periodically review this notice for the latest information on our privacy practices. After such notice, use of our services by users in countries outside the European Union will be understood as consent to the updates to the extent permitted by law.