Welcome to our privacy notice.
We respect your privacy and we are committed to protecting your personal data. This privacy notice will inform you as to how we look after your personal data when you visit our website, (regardless of where you visit it from) and tell you about your privacy rights and how the law protects you.
This privacy notice is provided in a layered format, so you can click through to the specific areas set out below. Please also use the Glossary to understand the meaning of some of the terms used in this privacy notice.
1. Important information and who we are
2. The data we collect about you
3. How is your personal data collected?
4. How we use your personal data
5. Disclosures of your personal data
6. International transfers
7. Data security
8. Data retention
9. Your legal rights
Purpose of this privacy notice
This privacy notice aims to give you information on how we collect and processes your personal data through your use of this website, including any data you may provide through this website when you register with us to perform tasks related to the SOBI003-001 Clinical Trial.
We may collect data relating to children on this website, but we require explicit consent from a legal parent or guardian in order to do so. How we do this is explained on Page 6.
It is important that you read this privacy notice together with any other privacy notice or fair processing notice we may provide on specific occasions when we are collecting or processing personal data about you so that you are fully aware of how and why we are using your data. This privacy notice supplements the other notices and is not intended to override them.
This Website is owned by Swedish Orphan Biovitrum AB (publ), henceforth referred to as Sobi, and managed by Syneos Health and Neonstone Ltd as agents acting on behalf of Swedish Orphan Biovitrum AB (publ) (individually the ‘Company’, and collectively the ‘Companies’ or ‘we’ or ‘us’) in this privacy notice).
For the purpose of applicable data protection law, the data controller is Swedish Orphan Biovitrum AB (publ) and the data processors are Syneos Health and Neonstone Ltd.
Sobi has appointed a data protection officer (DPO) who is responsible for overseeing questions in relation to this privacy notice. If you have any questions about this privacy notice, including any requests to exercise Your legal rights, please contact the DPO using the details set out below.
Full name of legal entity: Swedish Orphan Biovitrum AB (publ)
Name or title of DPO: Max Tullberg
Email address: Privacy@sobi.com
Postal address: SE-112 76 Stockholm, Sweden
You have the right to make a complaint at any time to the Swedish Data Protection Authority (Sw. Datainspektionen), because the controller, Sobi, is established in Sweden. If you live in the European Economic Area (EEA), you may also contact the data protection supervisory authority in the country where you live. We would, however, appreciate the chance to deal with your concerns before you approach a data protection supervisory authority so please contact us in the first instance.
Changes to the privacy notice and your duty to inform us of changes
This version was last updated on 13 August 2018 and historic versions can be obtained by contacting us.
It is important that the personal data we hold about you is accurate and current. Please keep us informed if your personal data changes during your relationship with us.
This website may include links to third-party websites, plug-ins and applications. Clicking on those links or enabling those connections may allow third parties to collect or share data about you. We do not control these third-party websites and are not responsible for their privacy statements. When you leave our website, we encourage you to read the privacy notice of every website you visit.
We may collect, use, store and transfer different kinds of personal data about you which we have grouped together follows:
We also collect, use and share Aggregated Data such as statistical or demographic data for any purpose. Aggregated Data may be derived from your personal data but is not considered personal data in law as this data does not directly or indirectly reveal your identity. For example, we may aggregate your Usage Data to calculate the percentage of users accessing a specific website feature. However, if we combine or connect Aggregated Data with your personal data so that it can directly or indirectly identify you, we treat the combined data as personal data which will be used in accordance with this privacy notice.
If you fail to provide personal data
We use different methods to collect data from and about you including through:
We will only use the personal data collected within this portal for the purpose of carrying out a clinical study. Processing of your Personal Data includes where we may adapt, align, alter, combine, consult, destroy, disclose by transmission, dissemination, erase, organize, record, restrict, retrieve, store, structure, use, or otherwise make available.
Change of purpose
We will only use your personal data for the purposes for which we collected it, unless we reasonably consider that we need to use it for another reason and that reason is compatible with the original purpose. If you wish to get an explanation as to how the processing for the new purpose is compatible with the original purpose, please contact us using the contact details provided above.
If we need to use your personal data for an unrelated purpose, we will notify you and we will explain the legal basis which allows us to do so.
Please note that we may process your personal data without your knowledge or consent, in compliance with the above rules, where this is required or permitted by law.
We may have to share your personal data and/or the personal data of study subjects transmitted via this portal with the parties set out below:
We share your personal data with authorized vendors and service providers of Swedish Orphan Biovitrum AB (publ) and Syneos Health for the purposes described above and subject to strict access control. This may involve transferring your data and any data transmitted via the portal outside the European Economic Area (EEA).
Many of our external third parties are based outside the European Economic Area (EEA) so their processing of your personal data will involve a transfer of data outside the EEA.
Whenever we transfer your personal data out of the EEA, we ensure a similar degree of protection is afforded to it by ensuring at least one of the following safeguards is implemented:
Please contact us using the contact details provided above if you want further information on the specific mechanism used by us when transferring your personal data out of the EEA.
We have put in place appropriate security measures to prevent your personal data from being accidentally lost, used or accessed in an unauthorised way, altered or disclosed. In addition, we limit access to your personal data to those employees, agents, contractors and other third parties who have a business need to know. They will only process your personal data on our instructions and they are subject to a duty of confidentiality.
We have put in place procedures to deal with any suspected personal data breach and will notify you and any applicable regulator of a breach where we are legally required to do so.
How long will you use my personal data for?
We will only retain your personal data for as long as necessary to fulfil the purposes we collected it for, including for the purposes of satisfying any legal, accounting, or reporting requirements.
To determine the appropriate retention period for personal data, we consider the amount, nature, and sensitivity of the personal data, the potential risk of harm from unauthorised use or disclosure of your personal data, the purposes for which we process your personal data and whether we can achieve those purposes through other means, and the applicable legal requirements.
Details of retention periods for different aspects of your personal data are available in our retention policy which you can request from us by contacting us.
Under certain circumstances, you have rights under data protection laws in relation to your personal data:
If you wish to exercise any of the rights set out above, please contact us using the contact details provided above.
No fee usually required
You will not have to pay a fee to access your personal data (or to exercise any of the other rights). However, we may charge a reasonable fee if your request is clearly unfounded, repetitive or excessive. Alternatively, we may refuse to comply with your request in these circumstances.
What we may need from you
We may need to request specific information from you to help us confirm your identity and ensure your right to access your personal data (or to exercise any of your other rights). This is a security measure to ensure that personal data is not disclosed to any person who has no right to receive it. We may also contact you to ask you for further information in relation to your request to speed up our response.
Time limit to respond
We try to respond to all legitimate requests within 28 days. Occasionally it may take us longer if your request is particularly complex or you have made a number of requests. In this case, we will notify you and keep you updated.
Legitimate Interest means the interest of our business in conducting and managing our business to enable us to give you the best service/product and the best and most secure experience. We make sure we consider and balance any potential impact on you (both positive and negative) and your rights before we process your personal data for our legitimate interests. We do not use your personal data for activities where our interests are overridden by the impact on you (unless we have your consent or are otherwise required or permitted to by law). You can obtain further information about how we assess our legitimate interests against any potential impact on you in respect of specific activities by contacting us
Performance of Contract means processing your data where it is necessary for the performance of a contract to which you are a party or to take steps at your request before entering into such a contract.
Comply with a legal or regulatory obligation means processing your personal data where it is necessary for compliance with a legal or regulatory obligation that we are subject to.
Internal Third Parties
Other companies in the company groups of Swedish Orphan Biovitrum AB (publ) or Syneos Health who are based in the European Economic Area, the United States of America or Turkey.
External Third Parties