Privacy Policy

Privacy Policy for Ameli-BioGroup

Introduction

The collection and analysis of the most confidential and personal information about people is of fundamental importance for conducting medical research. Ameli-BioGroup understands that in order for individuals to share their most sensitive personal information with Us, We must have a culture of trust and that We will store data following safe data management practices.

Ameli-BioGroup, together with its affiliates and subsidiary companies (collectively “Ameli-BioGroup,” “We,” “Us,” or “Our”), is committed to ensuring that We handle all individual information in a responsible and careful manner and in accordance with applicable data privacy and confidentiality laws in the UK and other countries.

This Privacy Policy (“Policy”) outlines and describes Our commitment as an organisation to the individuals whose data We manage, the key types of personal data We collect, process and how that information may be used or disclosed. The Policy explains in general terms how We strive to comply with data privacy laws, including without limitation the UK General Data Protection and the Data Protection Act 2018, EU General Data Protection Regulation, and any subsequent amendments to this regulation or local law equivalent that is later adopted, and any applicable local law (“Law(s)”) and the privacy and confidentiality requirements of ICH Good Clinical Practice.

Who Are We?

Ameli-BioGroup is a dedicated clinical trial site focused on connecting patients with innovative treatments and research opportunities. Ameli-BioGroup provides patient engagement and recruitment services and conducts ethically approved clinical research and medical trials for pharmaceutical and biotechnology companies, medical device companies, and other contract research organisations (“Sponsor” and/or “Client”). Ameli-BioGroup also provides healthcare and professional consultancy services for its Clients.

Please read the following carefully to understand Our views and practices regarding personal data information and how We will treat it.

Types of Personal Information Managed by Ameli-BioGroup

In our capacity as a Clinical Trial Site providing services for participants and sponsors, we host and analyse significant quantities of health data relating to clinical trial participants and individuals who have volunteered to be on a clinical trial and are assessed for eligibility to enter a clinical trial. Ameli-BioGroup also collects, processes, and manages personal information about its employees, Clients, and other service providers during the course of its business operations. Ameli-BioGroup also processes contact information provided by members of the public via its website.

Ameli-BioGroup may be the data processor or the controller for different types of personal data, and the legal basis for this processing may differ for each activity. The specific arrangements for each type of personal information we process are described in detail below:

Clinical Trial Participant Information

The integrity of a clinical trial relies on the accurate delivery of the clinical trial protocol, and these stringent measures ensure that new medications, once approved by regulatory authorities for use by humans, can ultimately be used to benefit health and social care of humans.

Ameli-BioGroup collects, gathers, and manages personal data from individuals who have expressed their interest in an Ameli-BioGroup clinical trial and have provided their consent to their participation in a clinical trial and/or to be considered for a clinical trial. We only use personal data for the purposes for which we have collected the information.

Personal data, including sensitive personal data, is collected and processed to match prospective participants to the eligibility requirements of relevant clinical trials, to conduct and deliver clinical trials, and to analyse their results. This data may include personal information such as contact details, date of birth, gender, race, ethnicity, physical or mental disability, sex (including pregnancy and related medical conditions), genetic information (including familial genetic information), and GP Surgery details, health information including current health status, health behaviours, and medical history information obtained from the individual, or their GP or other method of collecting information in a local country (e.g., NHS England) that identifies the participant, such as their passport or other identifying documents, photographs; and clinical trial data, which includes the individual’s eligibility to enter the clinical trial, treatments administered, clinical tests, observations and assessments (including samples such as blood and genetic tests) collected during the clinical trial, and any follow-up period.

We do not use automated individual decision-making when processing medical records, but we do use search tools to identify registered individuals who may be suitable for further assessment. Eligibility is always verified by a qualified healthcare professional prior to participation in any clinical trial.

Ameli-BioGroup is the controller or processor of this data and has a legitimate interest in processing and retaining this information in accordance with applicable Laws and/or regulations, even if the individual does not enter the trial or withdraws from the trial after enrolment. Sponsor and regulatory representatives may audit or inspect Ameli-BioGroup’s data for quality and safety purposes, which may include personal data belonging to the clinical trial participant. However, this activity is strictly controlled, and these representatives are not permitted to remove any identifiable participant data from Ameli-BioGroup.

Ameli-BioGroup deliver clinical trial activities, and to process personal data on its behalf, including monitoring whether potential participants were previously on a clinical trial. All processors are required to put in place appropriate safeguards to ensure the protection of personal data. They are subject to contractual restrictions on the processing of this data, which reflect their legal and contractual obligations under UK and EU GDPR and/or applicable local Law relating to personal data.

We may also process information for individuals who have consented to being considered for participation in future clinical trials. Ameli-BioGroup is the data controller of this information and processes this data under the legal basis of Ameli-BioGroup‘s legitimate interest in offering clinical trial recruitment services.

Ameli-BioGroup shares the data collected during a clinical trial with the clinical trial Sponsor. This information is pseudonymised, which means that the personal data, which could be used to identify the individual, is removed and replaced with a special code prior to it being shared. Only Ameli-BioGroup can use this code to link the pseudonymised data back to the individual. The Sponsor controls this pseudonymised data and is legally obliged to process and retain it in accordance with applicable Laws and/or regulations.

During the initial and on-going communications with the potential clinical trial participant and successful clinical trial participant, we record all calls for training and monitoring purposes.

Industry Professional Information

Ameli-BioGroup will liaise with its customers and/or Clients, employees, consultants, contractors, and other third parties employed or engaged by our Clients when conducting our clinical trials and research activities. Ameli-BioGroup will record and control personal data, including the names, contact details, and other professional information on these individuals for legitimate business-related purposes, including project and financial administration. This information may be used (including email addresses), to provide background on Ameli-BioGroup‘s services for Our Clients.

Employee and Human Resource Data

We collect and control personal information from applicants pursuing employment with Ameli-BioGroup and Ameli-BioGroup employees for its legitimate business-related purposes. Such professional or employment-related data includes private contact details, professional qualifications, and previous employment history, DBS, and professional disbarment checks to assist with personnel recruitment, staff performance, payroll, security, safety of Our premises, and tax purposes. Ameli-BioGroup processes similar information relating to consultants, contractors, and other third parties that We engage to deliver products or services.

Website Visitors Information

Generally, anyone can visit the Ameli-BioGroup website without revealing who they are and without disclosing any of their personal information. However, Ameli-BioGroup collects names and contact details volunteered by visitors to Our company website when making an online enquiry via the site. This includes enquiries, for example, by industry professionals regarding information about company services or when members of the public are interested in volunteering for a clinical trial or applying for a job vacancy with the company. Ameli-BioGroup may collect various data via cookie-based technologies, linked to virtual identities allocated to visitors when they access Our websites, such as browsing history, device ID, search history, IP address (Internet Protocol address), information on the visitors’ interaction with a website, device geolocation, application type and version, or advertisements placed and ad interactions. This information is used for website analytics and for first-party marketing. These virtual identities are sometimes connected with real-world identities of visitors when they submit named details. This enables Ameli-BioGroup to personalise marketing messages to make them relevant to those visitors. Ameli-BioGroup is the data controller of this information and processes it for legitimate business-related purposes in engaging with members of the public in the delivery of clinical research services, employment opportunities, and business development.

Your Rights

In accordance with data privacy Laws and contractual commitments, Ameli-BioGroup ensures that individuals can exercise all relevant informational rights with respect to their personal information processed by the organisation. Where no overriding legal obligation or legitimate interest prevails, Ameli-BioGroup will endeavour to allow the following informational rights under this Policy as a matter of good practice. These may include:

To allow access to copies of personal information;
To correct personal information where inaccurate;
To erase personal information;
To object to Ameli-BioGroup‘s use of personal information;
To restrict Ameli-BioGroup‘s use of personal information;
To withdraw a previously provided consent to the processing of personal information;
To receive personal information in a usable electronic format and transmit it to a third party (right to data portability);
To lodge a complaint with the local data protection authority if one exists in the country where the personal data was collected.

Information collected about individuals who are assessed for eligibility or enrolled in a clinical trial is subject to overriding legal obligations to ensure the safety and integrity of the trial. This means that some informational rights are restricted in these circumstances, including the individual’s right to access the personal data we hold about them, to the correction of their personal data when incorrect, out of date or incomplete, to withdraw consent or object to further processing of their personal data, to request deletion of personal data we hold about them, to restrict aspects of data processing, or to request transmission of personal data in a common digital format (e.g., PDF) to themselves or another organisation.

Participants enrolled in a clinical trial should discuss any concern with their Principal Investigator, who will be able to identify the participant and progress their request accordingly. Principal Investigator’s contact details are provided in the clinical trial-specific information leaflet, or they can be contacted via the Ameli-BioGroup clinical trial site. Contact details for Ameli-BioGroup clinical trial sites are available at the following web address: https://amelibiogroup.com/contact-us/.

Inquiries, Complaints, and Requests to Exercise Rights

Communications, queries, requests to exercise informational rights (e.g., access to data), or complaints can be addressed for the attention of the Data Protection Officer (DPO) at AMELI-BIOGROUP LTD, M25 BUISNESS CENTRE,121 BROOKER ROAD,EN91JH.

Legal Status of Policy and Policy Changes

This Policy is not a contract, and it does not create any legal rights or obligations. Ameli-BioGroup reserves the right to modify or amend this Policy and may do so according to new or amended legislation. The updated Policy will be posted on: https://www.amelibio.com/ (Last Updated: 27th Nov 2024). Changes and additions to this Policy are effective from the date on which they are posted.