Privacy Notice for Volunteers

Privacy Notice for Volunteers

Who we are?

We are Comac Medical Ltd., a full-service privately owned boutique CRO/SMO with more than 290 full-time employees, operating in several European countries covering population of over 390 mln: Bulgaria, Romania, Spain, Italy, Serbia, Macedonia, Croatia, Bosnia and Herzegovina, Montenegro, Belarus, Moldova, Georgia (South-Eastern Europe), Lithuania, Latvia, Estonia (Baltic region), Poland, Hungary, Slovenia, Kosovo, Albania, Cyprus, Greece, Kazakhstan, United Kingdom, Czech Republic, Turkey and USA.

Our details as a corporate entity and as a data controller are:

Comac Medical Ltd., UIC 103174683.

Our affiliate which we may act in terms of joint controllership is Medical Center Comac Medical Ltd. UIC 200920381 both having registered address in Sofia, Bulgaria, 131 Odrin str., 5th floor, and correspondence address:

69 Bulgaria Blvd.,
Tower B, 7 Floor
1404 Sofia, Bulgaria

Tel: +359 2 892 10 00

Fax: +359 2 892 10 01

Data Protection officer: privacy@comac-medical.com.

If you are only visitor to our website, we do not process any particular personal data except for the basic information about IP address, location, device, cookies as stated below and, in our Cookies, Notice.

If you have decided to complete our Study Volunteer Form, you need to know that these application forms aim to declare your interest and to be included in our database of prospective Volunteer to participate in a potential Clinical Study Research/Trial. The database is intended to be used as a pool where we may search for volunteers to be included in potential clinical study research/trial conducted by us upon contractual assignment of the Sponsor. These data may be used also for pre-screening. Entering the data base does not guarantee that you will be selected and/or offered to participate into any particular clinical study research/trial.

By way of providing the relevant information with regards to the personal data processing, it is vitally important to read this Privacy Notice before giving your consent. Should you have any questions and concerns in this regard, feel free to contact our Data Protection Officer at privacy@comac-medical.com.

  1. What kind of personal data do we collect and process?

In order to register your interest of being included in our potential Volunteers Data Base, we need to collect and to process a specific set of information, including personal data.

We process information of your name, title, gender, date of birth, phone number including country code, e-mail, address, postal code, city, country, your preferences about the field of the prospective clinical study research/trial which you are willing to participate. We may ask for some health data (such as blood pressure, weight, height, smoking, chronic illnesses) and in this regard we`ll process these data based on your explicit consent. It may be obtained via electronic statement (by submitting the application form) or via phone call on +359 2 892 1071 by following the instructions of the operator.


On a later stage we may also ask for name, personal ID number, identity card/passport number, date and place of birth, citizenship, signature, video image, photo, address, medical condition (data resulting from specific technical processing relating to your/your child physical, physiological or behavioral characteristics, data relating to the inherited or acquired genetic characteristics, data related to your/your child physical or mental health, the provision of health care services, which reveal information about your /your child health status), race, ethnicity, contact details (telephone) and to store in Comac Medical database for as long as needed and in compliance with the European regulation (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016) and the applicable local laws and regulations.


When you are using the website, we may process information related to your approximate location, IP address, your web preferences as it is stated in our Cookies Policy, the way you navigate and interact with this website. The purpose is to improve the functionalities of our website and our services.


Sometimes we may conduct remarketing campaigns for the purpose of enhancing the visibility and the transparency of our activity and our services.


  1. How do we obtain personal data?

For the purpose of maintaining the database described herein, we obtain your data directly from you. There is an option to provide your personal data via phone call on +359 2 892 1071 by following the instructions of the operator. For that purpose, please use the same number as the one provided in the web form, if you have previously submitted it.


By way of using this web site and its forms, we may automatically collect information about your IP address, approximate location, device (type of the device – mobile or PC), log data, usage information, and cookies.


The information about the location is not specifically tracked but provides information about the geographic area where your device interacts with our web site as indicated by the IP address of another similar identifier.


More information about the cookies you may find in our Cookie Policy.


  1. For what purpose it is necessary to provide your personal information?

In order to be able to include you in our database of future Volunteers we need a set of personal data which is used to conduct a preliminary assessment of your eligibility and pre-screening. In addition, your personal data is necessary to contact you, in case further verification of your interest or additional information (if needed). We`ll need to contact you also if we would like to invite you to participate in the respective clinical study research/trial as a Volunteer.


It is possible also to see ads for our activities, services and/or products by remarketing campaigns if you enabled these types of cookies.


We may use the personal data for statistical and archiving purposes. In this case we apply appropriate technical and organizational measures to ensure personal data protection.


We do not plan to further process your personal data for purposes other than those specifically described herein. In case of changes, we`ll notify you prior to that further processing.


  1. Which is the legal basis of processing and why do we need your consent with regards to the personal data processing?

To be included in our database is a voluntary act, based on your explicit consent. By giving your consent you declare your will to be included in our database as well as your personal data to be processed in this regard. Your consent needs to be freely given, specific to the purposes described herein, informed as it is stated in this Privacy Notice, explicit and unambiguous. You will have the opportunity to withdraw your consent at any time by sending an email to privacy@comac-medical.com.


For archiving and statistical purposes, we rely on legitimate interest or legal obligation, depending on the relevant circumstances.


For remarketing campaigns, we rely on your consent.


Your personal data including health data may be processed either on basis of explicit consent or when it is necessary for reasons of public interest in the area of public health such as ensuring high standards of quality and safety of health care and medicinal products.



  1. What would be the consequences in case you do not provide your consent to processing personal information?

If we do not have your valid consent for personal data processing, we cannot include you in our database. We will exclude you and will immediately stop processing your personal data if your consent is not valid or if we have a reasonable assumption that your consent might be invalid.


  1. Do we share your personal information with internal organizations?

We may share your personal data with our affiliates in Bulgaria and/or local offices in other countries, which are affiliates of Comac Medical too and we share the same pool of Clinical research information and resources. These companies are: “Comac Medical” Ltd. (Bulgaria)/ Comac Medical Hungary (branch of the Bulgarian Entity) / S.C. Comac Medical S.R.L.(Romania)/ Comac Medical D.O.O.(Serbia)/ Comac Medical DOOEL (Macedonia)/ UAB Comac Medical (Lithuanian)/ UAB Comac Medical Poland (branch of the Lithuanian Entity) Comac Medical LLC (Georgia)/ Comac Medical D.O.O. (Bosnia and Herzegovina)/ Comac Medical D.O.O. (Croatia)/ Comac Medical  SHPK (Albania)/ COMAC MEDICAL LTD BULGARISTAN ISTANBUL MERKEZ SUBESI


  1. Do we share your personal information with external organizations?

If required for the respective potential clinical research/trial, we may share your information with the Sponsor, partners, contract research organizations.


  1. For how long do we retain your personal information?

We retain your personal data for no longer than is necessary for the purposes for which the personal data are processed. In some cases, your personal data may be stored for longer periods insofar as the personal data will be processed solely for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with the applicable law.


The retention period will be 25 years if/when it is required by the law, the Good Clinical Practice or the volunteer recruitment is included in the clinical study research/trial protocol.


  1. Do we transfer your personal data internationally and outside the EU?

If required for the respective potential clinical research/trial, we may have sponsors, partners, other investigators and sites these participants may be established or located in a foreign country including outside European Union. When we prepare a clinical trial/research or other related activities with international coverage, we may transfer your data to our affiliates, some of them outside EU. In most of the cases, this transfer is carried out during the clinical study/trial itself, under the appropriate legal basis.


For certain operations we may or may be required to use information systems which may be hosted outside EU and your account data may be transferred, if necessary, for contract fulfilment or for the purpose of database maintenance.


When the sponsor is located outside EU/EEA we may share the required personal data with it for contract performance, drug safety or other compliance purposes.


We use interactive tools from Facebook, LinkedIn, YouTube, Google Maps and Google analytics which may transfer your IP address, web preferences as it is stated in our Cookies Policy in other countries, including outside EU.


  1. How do we protect your rights and freedoms in case of non-EU personal data transfer?

For several non – EU countries, the European Commission explicitly adopted a decision that these countries provide an adequate level of data protection mechanism and if your personal data is transferred to them no specific additional safeguards are needed from our side. Currently, The European Commission has so far recognized Andorra, Argentina, Canada (commercial organizations), Faroe Islands, Guernsey, Israel, Isle of Man, Japan, Jersey, New Zealand, Switzerland, Uruguay and the United States of America (limited to the Privacy Shield framework) as providing adequate protection. Potentially also United Kingdom and South Korea might be recognized.


In case we transfer your data to other countries not listed above we use standard contractual clauses or another appropriate safeguards in accordance with the applicable law to ensure the equal level of protection as in EU.


When there is a need to transfer personal data for important reasons of public interest such as public health, the transfer may not be occasional. In exceptional cases, where it is not possible or appropriate to apply any of the safeguards, we`ll ask for your explicit consent. You should be aware that in these cases there is a risk your rights related to privacy to be limited and not to be provided with the same level of data protection as in EU/EEA.



  1. Can you withdraw your consent on personal data processing?

You can withdraw your consent at any time by sending an email to privacy@comac-medical.com


When the consent is given or confirmed via phone call, you may withdraw it by the same way – via phone call to +359 2 8921071 by following the instructions of the operator. For that purpose, you need to call from the same phone number used initially to provide your consent.


Be advised that the consent withdrawal will not corrupt the lawfulness of data processing prior its withdrawal.


The consent withdrawal will not have any negative consequences towards you.


The only possible result from consent withdrawal would be your exclusion from our data base with possible volunteers for eventual future clinical trials/studies.


  1. Do we perform automated decision – making, including profiling?

We do not execute automated decision – making, apart the analytics described in our Cookie Policy.


  1. How do we protect your personal data?

The connection of our web site where you fill your personal information is ensured through secured Hypertext Transfer Protocol Secure.


Comac Medical Ltd. has implemented appropriate technical and organizational measures to protect your rights and freedoms concerning personal data protection including to prevent unauthorized access, disclosure, loss and/or alteration.


  1. What are your rights with regards to the personal data processing?


  • Right of access

You have the right to request information whether we process personal data related to you and certain additional information in this regard such as for purposes of processing, categories of personal data, recipients to whom your personal data have been or will be disclosed to particular recipients in thirds countries.


  • Right of rectification

You have the right to request that your personal data be corrected if any changes have been made or found to be incomplete or inaccurate.


  • Right to erasure (“right to be forgotten”)

You have the right to request that your personal data to be deleted when it is no longer needed for the purposes for which it has been processed, when you withdraw your consent on which the processing is based and where there is no other legal ground for the processing.


You are entitled to request the erasure of your data when the data have been unlawfully processed; if your data need to be erased for compliance with a particular legal obligation.


After considering all the circumstances of this request, we may refuse to delete your personal data if the processing is necessary to comply with a legal obligation which is applicable to us or for reasons of a public interest in the area of public health, for archiving purposes in the public interest, scientific, statistical purposes or for establishment, exercise or defense of legal claims.


The exercise of the right of erasure may not affect the rights and freedoms of others.


  • Right to restriction of processing


You have the right to request a restriction of processing while we consider your rectification request – until verifying the accuracy of your personal data.


You may also request a restriction on processing when you do not want your personal data to be deleted, including in connection with the exercise or protection of legal claims. Processing restriction may also apply if you have objected against automatic decision-making or profiling or during the pending verification whether our legitimate interests override yours.


  • Right to data portability


You have the right to receive personal data that concerns you and that you have provided to us, in a structured, widely used, and machine-readable format, and you have the right to request that we transfer this data to another controller in the following cases:

  • Processing is based on consent or on a contract and it is carried out automatically.


When exercising this right, the transfer can be made by us to another controller only when it is technically feasible.


This right shall not apply to the processing necessary for the performance of a public interest task.


The exercise of the right of portability may not affect the rights and freedoms of others.


  • Right to object


When decisions are made against you (if any), it is only based on automated processing of your data, including profiling, that you may object.


This right may not be always applicable depending on your particular situation.


When processing your data for direct marketing purposes (when such is done), you have the right to object to such processing at any time and your processing of personal data for that purpose will be terminated.


Depending on your particular situation, at any time of the processing of your data on the grounds of legitimate interest, or processed for scientific, historical or statistical purposes, you have the right to object before us. In this case, we shall no longer process your data unless we demonstrate compelling this legitimate ground for the processing which overrides your rights and freedoms or for establishment, exercise or defense of legal claims or it is carried out for reasons in public interest.


  • Right to lodge a complaint with a supervisory authority

Within the EU, you have the right to complain to a supervisory authority about how your information is handled and/or when you feel your rights and freedoms regarding personal data processing are violated.


If you have provided your consent, you may withdraw it at any time as stated above.



  1. How to file an inquiry, complain or requests in terms of data protection?

You may file an inquiry, complain or requests in terms of data protection by sending an email to privacy@comac-medical.com.


To handle your request, we may require additional identification.


To facilitate the process, we may require also to fill specific request form to exercise your rights, especially if your request is unclear. In this case, we will provide you with the respective form.


If you act through a proxy or on behalf of someone else, you need you provide us with the valid power of attorney under the applicable law.


  1. Do we use cookies on our website?


For this site, sometimes we store small data files called cookies on your device, to make the website work properly. Most major websites also use this method. You can check through your browser what cookies you use; how long cookies are stored and how to manage them.


  1. Cookies and marketing tools integrated to this web site?

What are cookies?

Cookies are small text files that are saved to your computer or mobile device when you visit a website. They allow the website to store your actions and preferences (such as username, language, font size, and other display settings) for a specified period so you don’t have to enter them every time you visit the site or switch from page to page.


How to control cookies


You can block, disable and/or delete analytics and marketing cookies whenever you like – see https://aboutcookies.org/ for more information. In addition, you can delete any cookies already stored on your computer, and you can also set most browsers to block them. However, if you do this, you may need to manually adjust some parameters each time you visit a site, and some services and features may not work.

All modern browsers allow you to change your cookie settings. You can usually find these settings in the “options” or “preferences” menu of your browser. To be aware of these settings, the following links may help, or you can use the “Help” button in your browser menus for more details:


Cookie settings in Internet Explorer

Cookie settings in Edge

Cookie settings in Firefox

Cookie settings in Chrome

Cookie settings in Opera

Cookie settings in Safari


  1. Linking to external web pages?

Our website contains links and may redirect you other websites, such as Facebook, Google, LinkedIn, which are independent data controllers and may process your data on their own legal basis. Please, when you use other websites and external systems, nevertheless you are redirected from our website, read carefully their information regarding personal data processing.


Besides, there are embedded links to LinkedIn, Facebook, Google.


  1. Changes in this Privacy Notice?

We reserve the right to modify or amend this Privacy Notice. For instance, it may need to change as new legislation is introduced or as it is amended. The updated Privacy Notice will be posted on this website. When it is reasonable and/or in case of significant changes we will notify the individuals, enrolled in our database via your registered email or by posting a visible message on our website.