MERCLINCO (PTY) LTD

1. INTRODUCTION

MERCLINCO (Pty) Ltd (“MERCLINCO”, “we”, “us” or “our”) respects the privacy of individuals whose personal information we collect and process.

This Privacy Notice explains how we collect, use, store, share and protect personal information in accordance with the Protection of Personal Information Act 4 of 2013 (“POPIA”) and other applicable legal and regulatory requirements.

This Notice applies to personal information processed by MERCLINCO in the course of its business and clinical research activities, including information relating to website visitors, research participants and potential participants, employees and job applicants, healthcare professionals, investigators, sponsors, contract research organisations (“CROs”), suppliers, service providers and other business contacts.

Where a clinical trial or research study has a specific informed consent form or privacy notice, the provisions applicable to that study should be read together with this Privacy Notice.

2. PERSONAL INFORMATION WE MAY COLLECT

Depending on the nature of our relationship with you, MERCLINCO may collect and process personal information including:

– name, surname and identification information;

– contact details, including telephone numbers, email and physical addresses;

– demographic information;

– employment, professional, qualification and registration information;

– information contained in correspondence, enquiries or applications;

– financial, banking or payment information where required;

– website and electronic communication information; and

– other information reasonably required for our legitimate business, research, regulatory or legal purposes.

As a clinical research organisation, MERCLINCO may also process **special personal information**, including health and medical information, where this is necessary and lawfully permitted.

Personal information relating to clinical trial participants is processed in accordance with applicable legislation, approved study protocols, informed consent documentation, ethics requirements and other applicable clinical research standards.

3. HOW WE COLLECT PERSONAL INFORMATION

We may collect personal information:

– directly from you;

– when you communicate or interact with MERCLINCO;

– when you submit an enquiry, application or other information to us;

– during recruitment or employment processes;

– as part of clinical research and study-related activities;

– from healthcare professionals, investigators, research sites, sponsors, CROs and authorised service providers;

– from public records or sources where legally permitted; and

– through our website and electronic systems.

Where required by law, MERCLINCO will obtain the necessary consent or other lawful authority before collecting or processing personal information.

4. WHY WE PROCESS PERSONAL INFORMATION

MERCLINCO may process personal information for purposes including:

– conducting and supporting clinical research and clinical trials;

– assessing eligibility for participation in research studies;

– communicating with research participants or potential participants;

– meeting regulatory, ethical and clinical research requirements;

– communicating with sponsors, CROs, investigators, healthcare professionals and research partners;

– responding to enquiries and requests;

– recruitment, employment and human resources administration;

– managing suppliers and service providers;

– administering contracts, payments and business relationships;

– maintaining the security and integrity of our systems and facilities;

– complying with legal, regulatory, contractual and reporting obligations; and

– establishing, exercising or defending legal rights.

We will not process personal information in a manner that is incompatible with the purpose for which it was collected unless permitted by law.

5. CLINICAL RESEARCH AND HEALTH INFORMATION

Due to the nature of MERCLINCO’s activities, we may process health information and other special personal information in connection with clinical research.

Clinical trial participant information may be shared with authorised parties involved in the conduct, oversight or regulation of a study, including sponsors, CROs, laboratories, ethics committees, regulatory authorities, monitors, auditors and other authorised research service providers, where applicable.

Where possible and appropriate, clinical research information may be coded, pseudonymised or otherwise processed in a manner intended to reduce the direct identification of individual participants.

Participation in a clinical trial is governed by the applicable study documentation, including the informed consent process. Participants should refer to the relevant informed consent documentation for detailed information regarding how their personal and health information will be processed for a particular study.

6. SHARING OF PERSONAL INFORMATION

MERCLINCO does not sell personal information.

We may share personal information where reasonably necessary and legally permitted with:

– clinical trial sponsors and CROs;

– investigators and healthcare professionals;

– laboratories and other clinical research service providers;

– ethics committees and regulatory authorities;

– auditors and monitors;

– IT, technology and data-storage providers;

– professional advisers;

– suppliers and service providers;

– government authorities or law enforcement agencies where required by law; and

– other parties where disclosure is authorised or required by law.

Where third parties process personal information on our behalf, MERCLINCO takes reasonable steps to ensure that appropriate confidentiality, privacy and security requirements apply.

7. INTERNATIONAL TRANSFERS

Clinical research frequently involves international sponsors, CROs, systems and service providers. Personal information may therefore, where necessary and legally permitted, be transferred to or accessed from countries outside South Africa.

MERCLINCO will take reasonable steps to ensure that international transfers of personal information are undertaken in accordance with POPIA and that appropriate safeguards are applied.

Study participants should also refer to the applicable informed consent documentation for information regarding international transfers relating to a particular clinical trial.

8. SECURITY OF PERSONAL INFORMATION

MERCLINCO takes reasonable and appropriate technical and organisational measures to protect personal information against loss, unauthorised access, interference, alteration, disclosure, destruction or misuse.

Access to personal information is restricted to persons who require access for legitimate and authorised purposes.

While MERCLINCO takes reasonable precautions to protect personal information, no electronic system or transmission method can be guaranteed to be completely secure.

9. RETENTION OF PERSONAL INFORMATION

MERCLINCO retains personal information only for as long as reasonably necessary for the purpose for which it was collected or as required by applicable legal, regulatory, contractual, ethical or clinical research requirements.

Clinical research records may be subject to specific retention requirements imposed by legislation, regulatory authorities, study protocols, sponsors or applicable clinical research standards.

When personal information is no longer required, it will be securely destroyed, deleted or de-identified where appropriate and subject to applicable legal requirements.

10. YOUR RIGHTS

Subject to POPIA and other applicable legislation, you may have the right to:

– request confirmation of whether MERCLINCO holds personal information about you;

– request access to your personal information;

– request correction or updating of inaccurate or incomplete personal information;

– request deletion or destruction of personal information where legally permitted;

– object to certain processing of your personal information;

– withdraw consent where processing is based on consent, subject to applicable legal and research requirements; and

– lodge a complaint regarding the processing of your personal information.

Certain rights may be limited where MERCLINCO is legally, ethically, contractually or regulatorily required to retain or continue processing information.

For clinical trial participants, withdrawal from a study or withdrawal of consent may be subject to the provisions of the applicable informed consent documentation and applicable research and regulatory requirements.

11. WEBSITE AND COOKIES

Our website may use cookies or similar technologies necessary for the operation, security and functionality of the website.

Where additional analytics, tracking or third-party technologies are used, appropriate information and choices will be provided where required.

You may also control certain cookies through your browser settings.

12. CHILDREN’S PERSONAL INFORMATION

MERCLINCO will only process personal information relating to children where permitted by law and where the appropriate consent, authorisation, ethical approval or other lawful basis is in place.

Additional protections and study-specific requirements will apply where children participate in clinical research.

13. SECURITY COMPROMISES

Where MERCLINCO has reasonable grounds to believe that personal information has been accessed or acquired by an unauthorised person, we will manage the incident and provide notifications as required by POPIA and other applicable requirements.

14. CONTACT US

Questions, requests or concerns regarding this Privacy Notice or the processing of personal information by MERCLINCO may be directed to:

MERCLINCO (Pty) Ltd

184 Cowen Ntuli Street 

Middelburg 

Mpumalanga 

South Africa 

info@mercresearch.com

15. INFORMATION REGULATOR

You have the right to lodge a complaint with the Information Regulator (South Africa) regarding the processing of your personal information.

Current contact information and complaint mechanisms are available directly from the Information Regulator.

16. CHANGES TO THIS PRIVACY NOTICE

MERCLINCO may update this Privacy Notice from time to time to reflect changes in our activities, legal or regulatory requirements, or privacy practices.

The latest version will be published on our website and will indicate the effective date of the Notice.