Protecting your privacy and personal data is very important to us. Personal data, that you provide, are processed and protected by us in accordance with applicable legal regulations, in particular the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, repealing Directive 95/46/EC (the "GDPR"). In the text below, you will find the information, which personal data are processed, for what purpose and what are your rights.
The company DCVT s.r.o., a limited liability company established under the laws of the Slovak Republic, with its registered seat at Panenská 18, 811 03 Bratislava – Staré Mesto, Slovak Republic, Company ID: 54 840 937, registered in Commercial Registry of Municipal Court Bratislava III, Sec. Sro, Insert Nr. 163703/B is the operator of the application called MELIOVIT designed for computers and mobile devices, in particular smartphones, which provides the information for the subjects of clinical trials and facilitates the delivery of investigational medicinal products and non-medicinal products from hubs (sites or other designated points) to the subjects of clinical trials (hereinafter referred to as "the Application") and the controller of the personal data of users obtained through the Application (hereinafter referred to as "the Controller").
The Controller processes personal data of the following categories of data subjects:
(A) In relation to the users of the Application (subject of clinical trials), the Controller processes only the contact information: name, surname, address, phone number and e-mail address and the information on scheduled appointments, if available. No personal health information is being processed by the Controller.The Controller does not process special categories of personal data within the meaning of Article 9 of the GDPR.
(B) In relation to the investigators and other medical personnel at the site, Controller processes: name, surname, address of the workplace (site), phone number and e-mail address.
(C) In relation to the hub operators at the hub, Controller processes: name, surname, address of the workplace (hub), phone number and e-mail address.
(A) The purpose of processing users' personal data is to register in the Application, to enable the delivery of investigational medicinal products and non-medicinal products from hubs to the user of the Application (subject of the clinical trial) without the need of the site visit, to provide the user of the Application with information on clinical trial he or she participates in, possibly including schedules medical appointments and to handle requests from data subjects in accordance with the GDPR.
(B) The purpose of processing personal data of investigators and/or other medical personnel is to provide the users of the Application with contact information to the site for obtaining further information and answers to their as well as to send relevant delivery process notifications to investigators and/or other medical personnel.
(C) The purpose of processing personal data of hub operators is to provide the users of the Application with a means of notifying these hub operators of any delivery process changes and updates.
The legal basis for the processing of your personal data is:
To protect your data against unauthorized access or manipulation, we have taken the necessary technical and organizational measures. These measures include the necessary software and hardware security, including firewall protection, data encryption, and restricted private key access only by authorized persons. These security measures are regularly tailored and continuously optimized to keep up with the latest technological developments.
Your personal data is stored only for as long as necessary to fulfil the purpose of processing personal data:
Please, note that the storage period of your data within the clinical trial you participate in (either as the subject, investigator or hub operators) can be different and is not affected by the use of the Application.
Information on the existence of automated decision-making, including profiling: Your personal data shall not be used for automated decision-making or profiling.
Your personal data is processed primarily in the member states of the European Union. The data processing shall take place in more than one EU member state.
The Controller does not intend to transfer your personal data to a third country or international organisation. However, the Controller may, if necessary, transfer personal data to a third country or an international organisation on the basis of adequacy decisions in accordance with Article 45 of the GDPR, or after taking appropriate safeguards in accordance with Article 46 of the GDPR and provided that the data subjects have enforceable rights and effective legal remedies, or in the case of exceptions under Article 49 of the GDPR. In the event of a transfer of personal data to third countries or to an international organisation, the Controller is obliged to inform the data subject thereof.
When using the Application, the Controller collects technical data from users, namely:
The technical data collected may be considered as personal data of users. The purpose of processing technical data is to ensure the functionality of the Application, to improve the functionality of the Application, to check compliance with the Terms of Use of the Application, to obtain data for further development of the Application, to obtain data on the use of the Application and to protect against misuse of the Application. The legal basis for the processing is Controller´s legitimate interests in accordance with Article 6(1)(f) of the GDPR, which are to ensure the functionality of the Application, to improve the functionalities of the Application, to check compliance with the terms of use of the Application, to obtain data for the further development of the GDPR, to obtain data on the use of the Application and to protect against misuse of the Application. Special categories of personal data within the meaning of Article 9 of the GDPR are not subject to processing.
Personal data is provided to companies that provide push notifications (Firebase) and email and sms notifications (Amazon Web Services).
The user is entitled to block the sending of push notifications at any time on his/her mobile device, however, the User acknowledges that some functions and notifications may be fully or partially restricted.
You as the data subject have the following rights in relation to the processing of your personal data:
Upon request, you have the right to obtain confirmation from the Controller as to whether personal data about you are being processed. Where that is the case, you have the right to request copies of your personal data and to information related to the processing.
Should you consider your personal data at our disposal are incorrect, inaccurate or incomplete, please, do not hesitate to ask us to amend, update or complete such information.
You have the right to request erasure of your personal data, e.g. in case if the obtained personal data are no longer necessary for original purpose of their processing. However, your right to erasure shall be assessed according to all relevant circumstances. For instance, we may have some legal and regulatory obligations concerning your personal data, which means we may not be able to satisfy your request.
You have the right to demand from the Controller the restriction of the processing of your personal data in certain cases, e.g. if you have doubts about the correctness of your personal data or if you believe we no longer need to use your personal data.
In certain cases, you have the right to request the transfer of personal data you provided to us to third party according to your choice. However, the right to transfer relates only to those personal data which we have obtained based on your consent or based on the contract you are a party to.
You have to right to object the processing of personal data which is based on our legitimate interests. If we have no substantial legitimate reason for processing of personal data and you make an objection, we will no longer process your personal data.
If you consider that we have breached data protection legislation, you may lodge a complaint with the respective supervisory authority in your country: https://edpb.europa.eu/about-edpb/about-edpb/members_en
If you have any queries regarding the collection and use of your data as part of your use of the Application, or regarding your rights or if you wish to invoke your rights, please contact our Data Protection Officer (DPO):
Goran Unkovski; DCVT s.r.o., Panenská 18, 811 03 Bratislava – Staré Mesto, Slovak Republic; contact@meliovit.com