CLINICAL TRIAL PRIVACY NOTICE

DemeRx NB is a clinical stage pharmaceutical development company advancing noribogaine for the treatment of addiction disorders.

We will at all times ensure that we meet our obligations as a Data Controller of your personal data. Our registered business address is 1951 NW 7h Ave Suite 600, Miami, FL 33133, USA.

This data privacy notice is addressed to all customers, vendors, suppliers, contact persons, and other individuals (“Data Subjects”, “you”) of or in contact with DemeRx NB (“DemeRx”, “us”, “we”). It is meant to help you understand what personal data we collect, why we collect it, and how you can exercise your data protection rights. “Personal Data” in this document is any information relating to an identified or identifiable natural person, by direct or indirect means. In some countries, this may be called “personally identifiable information”.

You might have been provided with a privacy notice or contract for a specific purpose. If that is the case, the terms of the notice or contract will control your interaction with DemeRx NB, to the extent that such notice or contract conflicts with this privacy notice.

We take your data privacy and the protection of your personal data seriously and our data privacy principles provide fundamental guidance to our business. We comply with applicable national regulations and will process your personal data in compliance with all applicable national and/or state privacy laws to meet our obligations. 

  • we process personal data lawfully, fairly and in a transparent manner in relation to you, the data subject.
  • we only collect personal data for a specific, explicit, and legitimate purpose. 
  • we ensure that personal data we process is adequate, relevant, and limited to what is necessary in relation to the processing purpose.
  • we take every reasonable step to update or remove data that is inaccurate or incomplete and guarantee to do so within the time frames set by any applicable laws.
  • we delete personal data when we no longer need it for the purposes for which it was collected or to meet applicable legal requirements.
  • we keep personal data safe and protected against unauthorised or unlawful processing and against accidental loss, destruction, or damage, using appropriate technical and organisational measures.

PROCESSING OF YOUR PERSONAL DATA

We usually process your personal data for contractual purposes and to communicate with you for commercial reasons when you or we purchase any goods or services from the other. For this purpose, we only process such data which is needed to fulfil the contract itself and to comply with additional obligations we are subject to, such as tax payments.

In addition, we might use some of your personal data, based on our legitimate interest, to develop and offer our products and services, learn more about your interests, conduct marketing activities under local market rules, and continuously improve our offerings.

We also process personal data for our scientific research based on our legal obligation, your consent, or as permitted for such research.

Please refer to the individual data privacy notices which we provide in the context of our business communication with you, for further details about the corresponding processing of your personal data in this context. An example of this is the Informed Consent Form you received by taking part in our research.

We collect your personal information via disclosure directly from you or in some cases someone you have nominated. This might be via our website, email, post, telephone, or face to face engagement.

CATEGORIES, TYPE OF PERSONAL DATA COLLECTED AND PURPOSES

The personal data we collect from you, will be the minimum required for us to achieve the intended purpose of its collection. This may be to respond to your requests to us for information or in seeking employment with us, working on our behalf within our clinical development activities or participating in a clinical study as a trial subject. 

The categories and types of personal data collected will range from names and basic contact details to more sensitive medical and health related information. All personal data collected will be treated as confidential and protected. 

We will not collect or process your personal data without ensuring that we are doing so on a basis which meets any applicable state or national laws. In general, we will collect and process your personal data based on the following: 

  • you have formally given us your expressed consent.
  • in meeting requirements of a contract between us.
  • it is in our or your legitimate interests.
  • it is in your vital interests.
  • to perform a public task.
  • we have a legal obligation to do so.

SECURING AND PROCESSING YOUR PERSONAL DATA

We take appropriate technical and organisational security measures to protect your personal data in compliance with applicable data protection and privacy laws, which includes; protection against accidental or unlawful destruction, loss, alteration, unauthorized access to, or disclosure of your personal data. 

When DemeRx NB retains a service provider, that provider will be carefully selected and required to use appropriate measures in accordance with applicable law to protect the confidentiality and security of personal data. That provider will only be permitted to process your data on the written instruction of DemeRx NB.

In the unlikely event that we lose your data, or a device on which your data resides, or it is accessed by someone unauthorised, we will inform you if the loss or unauthorised access of your data has potential to cause you harm. We may report this to the appropriate supervisory authority responsible for managing data protection within your jurisdiction.

SHARING OF PERSONAL DATA

Your personal data will only be shared with our own staff, associates, or contractors when it is necessary for them to have access to complete their assigned responsibilities or provide their contracted services. Sharing of your data will be relative to the nature of our engagement with you. 

We use the services of other organisations who are critical for the provision of our service to you and will be viewed as data processors. Their access is restricted, and they are contractually bound to strict confidentiality and the protection of your personal data. 

There may also be legal obligations under which we have to share data as requested by nationally recognised regulators or authorities and when we process your personal data as part of our clinical research and development activities. 

We may also pass information to external agencies and organisations, including the police, for the prevention and detection of fraud and criminal activity. Should any claim be made, we may pass your personal information to our insurers and, if our business is wholly or partially transferred to a third party, your personal information may be one of the transferred assets.

Sharing your personal data as described above may involve transferring it to other countries, whose data protection and privacy laws may not be equivalent to, or as protective as, those that exist in your country of residence. To ensure an adequate level of data protection is provided, transfers will be done in compliance with the international data transfer restrictions that apply under data protection laws, including, where appropriate, through the use of standard contractual clauses for international transfers.

HOW LONG DO WE KEEP YOUR PERSONAL DATA FOR 

Personal data will not be kept for longer than is necessary to fulfil its purpose. As an exception, we may be required to retain your Personal Data for longer periods as required or permitted by law, or as necessary to protect our rights and interests. In such a case, you will be informed of the intended retention period in the applicable Privacy Notice, Informed Consent Form, or Patient Information Sheet.

YOUR RIGHTS IN RELATION TO YOUR PERSONAL DATA

You have a number of rights related to the Personal Data that we Process about you (this will depend on the jurisdiction where you reside and the legal basis that we use). Most often, exercising your right is free of charge. We may also have to clarify your request and explain if we can comply with it or if this is restricted in your situation. 

Below we have listed individual rights that may apply depending on your jurisdiction. 

You may have the right to:

    • Receive a copy of the Personal Data we hold about you – Right of Access
    • Correct the Personal Data we hold about you – Right to Rectification
    • Ask us to delete your Personal Data or restrict how it is used in certain circumstances – Right to Erasure
    • Request that we cease processing your data in certain conditions – Right to Restrict Processing
  • You have the right to object to our processing in certain circumstances – Right to Object
  • Information related to Automated decision making or profiling. (We do not use automated decision-making or profiling)
  • Lodge a complaint to your designated supervisory authority – Right to lodge a complaint 

EXERCISING YOUR RIGHTS, MAKING AN ENQUIRY OR COMPLAINT

If you took part in a clinical trial as a study subject, you should ideally contact the institute where your trial took place (as we will not be able to identify you from the study data). Contact details will have been given on your Informed Consent Form or Patient Information Sheet. Failing this you can contact us directly using the details below. 

Email: dataprotection@demerx.com