Ameli-BioGroup

Where Innovation Meets Compassion

Data Privacy Statement

Ameli-BioGroup LTD

Effective Date: 27th Nov 2024
Address: M25 Business Center, 121 Brooker Road, EN9 1JH, United Kingdom

Introduction

At Ameli-BioGroup LTD, we recognize the significance of protecting sensitive personal information, especially in the context of medical research and clinical trials. We are committed to building a culture of trust and adhering to robust data management practices to safeguard this information.

This Privacy Policy (“Policy”) outlines our approach to data privacy, including the types of personal data we collect, how it is used, shared , and your rights under applicable laws such as:

  • The UK General Data Protection Regulation (UK GDPR)
  • The Data Protection Act 2018
  • The EU General Data Protection Regulation (EU GDPR)
  • Other applicable international and local data privacy regulations

We follow the highest ethical standards, including the ICH Good Clinical Practice guidelines, ensuring that your data is managed responsibly.

Who Are We?

Ameli-BioGroup LTD is a leading clinical trial site specializing in ethically approved clinical research. We work with pharmaceutical, biotechnology, and medical device companies to conduct high-quality clinical trials and ensure compliance with global regulatory standards.

Types of Information We Handle

  1. Clinical Trial Participant Information
    We collect and manage sensitive personal data from clinical trial participants, including health information, medical history, and clinical trial data.
  2. Industry Professional Information
    Data from clients, consultants, and third-party service providers involved in trials is handled for operational purposes.
  3. Employee and Recruitment Information
    We collect professional and personal data from employees, job applicants, and contractors for HR and business-related functions.
  4. Website Visitors Information
    We collect minimal information, such as contact details and browsing data, to improve our website’s functionality and user experience.
  5. Commercial Data
    Includes records of services provided, financial transactions, and correspondence with clients or participants.

Notice of Data Use and Consent

We provide clear and transparent notices about data usage and your rights at the point of collection. Depending on the method of collection, notices may be provided in person, via email, phone, or through our website.

In accordance with data privacy laws:

  • We seek your informed consent when legally required.
  • In specific circumstances, we process data without consent when it is lawful, such as to fulfill legitimate business interests or legal obligations.

For clinical trials, participants will receive detailed consent forms aligned with regulatory and ethical standards.

Data Quality, Integrity, and Retention

We are dedicated to maintaining accurate and secure data. Personal information is retained only for as long as necessary under contractual, regulatory, and scientific requirements. Usage data may be kept longer for internal analysis or legal compliance.

Participants will receive retention information prior to clinical trial enrollment.

Your Rights

Under data privacy laws, you have the following rights:

  • Access: Request access to your data.
  • Correction: Update or correct inaccuracies.
  • Erasure: Request deletion of your personal data.
  • Objection: Object to how your data is used.
  • Restriction: Limit how your data is processed.
  • Data Portability: Transfer your data in a usable format.
  • Withdraw Consent: Revoke previously given consent.

For clinical trial participants, certain rights may be restricted due to legal obligations to ensure trial safety and data integrity.

To exercise your rights, please contact our Data Protection Officer (DPO) (details below).

Information Security

We implement robust technical and organizational measures to protect your data against unauthorized access, loss, or breaches. Our incident response policy ensures timely action and notification in the event of a data breach.

Data may be processed or stored on servers in the UK or internationally, in compliance with applicable data transfer regulations.

Online Privacy and Cookies

Our website may use cookies to:

  • Enhance user experience
  • Analyze website performance
  • Deliver targeted marketing messages

You can manage your cookie preferences in your browser settings.

Children’s Online Privacy

Our website is not designed for individuals under 18. We do not knowingly collect data from children under 13. If you believe your child has provided information, contact us immediately.

Inquiries, Complaints, and Requests

If you have questions, wish to exercise your rights, or need to file a complaint, please contact:

Data Protection Officer
Ameli-BioGroup LTD
M25 Business Center
121 Brooker Road
EN9 1JH, United Kingdom

Alternatively, you may contact the UK’s Information Commissioner’s Office (ICO) at https://ico.org.uk/make-a-complaint/your-personal-information-concerns/.

Policy Changes

This Policy may be updated to reflect legal or operational changes. Please review it periodically for updates. The latest version is always available on our website:

Last Updated: 27 NOV 2024

Thank you for trusting Ameli-BioGroup LTD. We are committed to safeguarding your privacy and advancing clinical research with the highest standards of integrity.