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Introduction

The collection and analysis of the most confidential and personal information about people is of fundamental importance for conducting medical research. CliniSafe 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.

CliniSafe Limited, together with its affiliates and subsidiary companies (collectively “CliniSafe,” “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?

CliniSafe is a leading global Contract Research Organisation with a network of clinical research centres in multiple countries. CliniSafe 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”). CliniSafe 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 CliniSafe

In our capacity as a Contract Research Organisation providing services for 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. CliniSafe also collects, processes, and manages personal information about its employees, Clients and other service providers, during the course of its business operations. CliniSafe also processes contact information provided by members of the public via its website.

CliniSafe 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 is described in detail below:

1. 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.

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

Personal data, including sensitive personal data, is collected and processed to match prospective participants to the eligibility requirements of relevant clinical trials, and to conduct and deliver clinical trials and 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 (for example: NHS England) that identifies the participant, such as their passport or other identifying documents, photographs; and clinical trial data which includes the individuals eligibility to enter the clinical trial and any 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.

CliniSafe 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 CliniSafe’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 CliniSafe.

CliniSafe engages a range of specialist third-party service providers to 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. CliniSafe is the data controller of this information and processes this data under the legal basis of CliniSafe's legitimate interest in offering clinical trial recruitment services.

CliniSafe 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 CliniSafe 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.

2. Industry Professional Information

CliniSafe 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. CliniSafe 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 CliniSafe’s services for Our Clients.

3. Employee and Human Resource Data

We collect and control personal information from applicants pursuing employment with CliniSafe and CliniSafe 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 the personnel recruitment, staff performance, payroll, security, safety of Our premises and tax purposes. CliniSafe processes similar information relating to consultants, contractors and other third parties that We engage to deliver products or services.

4. Website Visitors Information

Generally anyone can visit the CliniSafe website without revealing who they are and without disclosing any of their personal information. However, CliniSafe 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 to a clinical trial or applying for a job vacancy with the company. CliniSafe 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 CliniSafe to personalise marketing messages to make them relevant to those visitors. CliniSafe 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.

5. Commercial Information:

CliniSafe will collect and use commercial information such as records of products or services purchased or obtained, or correspondence received. CliniSafe will also collect information for one or more of the following purposes: to fulfil or meet the reason for which the information is provided, including to process payments and other financial transactions; to provide information, products or services that are requested from Us; to provide electronic messages consisting of alerts, reminders, event registrations and other notices concerning Our products or services, appointments, events or news that may be of interest; to improve Our website and present its contents to visitors to the site; for testing, research, analysis and product or services’ development.

​Internal and External Disclosures of Personal Information

Personal information is only shared on a “need to know” basis within CliniSafe and its affiliates and subsidiaries and with relevant third parties (such as agents, contractors) to deliver stated legitimate business purposes and legal obligations. Any access to personal information contained within databases and binders is carefully restricted and only viewable by appropriate CliniSafe staff for legitimate purposes. CliniSafe does not trade or sell personal information.

​Under some circumstances, CliniSafe may be required by law enforcement agency, court, regulator, government authority, or judicial authorities or other third party to disclose certain personal information as part of investigations or for litigation purposes. Or, where We believe such disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect Our rights or the rights of any third party, including to identify or locate anyone for the prevention or detection of crime or the apprehension or prosecution of offenders. In such circumstances we expressly disclaim any liability from any claims resulting from such disclosures and from any actions taken as a consequence of investigations by either Us or law enforcement authorities.

CliniSafe may disclose and transfer personal information to a third party in connection with the sale, assignment, or other transfer of Our business to which the information relates.

​Any companies who work as third party contractors or agents for CliniSafe are required to sign “data processing agreements” as a processor and/or confidentiality agreements whereby they commit to only process personal information consistent with contracted purposes and to ensure organisational and technical security safeguards for the data​ are in place prior to any processing of personal data.

We also share aggregate, non-personal information about website usage with affiliated and unaffiliated third parties.

We may, for example, provide visitors information to agents, contractors, or partners for hosting Our databases, for data processing services, or so that they can mail information to that visitor if requested.

​Notice of Data Use and Consent

CliniSafe will provide notice to individuals using clear and conspicuous language at the point of data collection, about how their information will be used and disclosed. We will make clear what choices are available in relation to how individual personal data is managed and what rights there are under data privacy Law or under this Policy and who to contact with any questions or complaints. CliniSafe’s privacy notices are tailored according to specific data collection circumstances. In providing such notice, CliniSafe meets its obligations to be transparent and fair with individuals as is required by General Data Protection Regulation. Dependent on the medium, notice may be given in person, by email, post, telephone, or by posting on Our website.

​In accordance with data privacy Law and good practice, CliniSafe will seek consent of individuals to collect, use, and disclose their data consistent with the relevant privacy notice. However, in certain cases where the law allows processing of personal data, in particular where the intended processing of the personal data is in CliniSafe’s or Our Clients’ legitimate interests and the privacy risks are low, CliniSafe will proceed to process personal information absent of consent, for example, where gaining consent from a person will involve a disproportionate effort. CliniSafe will also use and disclose personal information without consent where required by law and judicial order to disclose information.

CliniSafe will collect all necessary informed consents of clinical trial participants on behalf of Clients, according to good clinical practice, Laws on confidentiality and data privacy regulations and Laws in the country where the consent is provided. CliniSafe’s interests are in conducting ethically approved clinical trials and following good clinical practice to the highest medical and scientific standards.

Data Quality, Integrity and Retention of Records

Data quality and accuracy is essential in ensuring the safety and integrity of clinical trials and the reliability of the scientific knowledge they generate. CliniSafe employs a number of specialists to ensure that data processing standards comply with all legal requirements. Our privacy notices provide individuals with straight-forward information on how to check, update and correct their information. CliniSafe retains personal information in accordance with contractual and regulatory requirements which may vary in different countries and/or across clinical trials.

We will retain this information for as long as necessary for the uses set out in this Policy and for a period permitted under applicable law, including as necessary to comply with our legal obligations, resolve disputes, enforce our legal agreements and policies, and protect Our property. We will also retain usage data for internal analysis purposes. Usage data is generally retained for a shorter period of time, except when this data is used to strengthen the security or to improve the functionality of the website, or We are legally obligated to retain this data for longer time periods. If you ask us to delete your information before this time, we may not be able to do so for technical, regulatory, or contractual constraints.

If you agree to take part in one of our clinical trials, we will provide detailed information regarding retention periods prior to your enrolment.

Your Rights

In accordance with data privacy Laws and contractual commitments, CliniSafe 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 to individuals requests, CliniSafe 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 Our use of personal information;
  • to restrict Our use of personal information;
  • to withdraw a previously provided consent to processing of personal information;
  • to receive personal information in a usable electronic format and transmit it to a third party (right to data portability); and
  • to lodge a complaint with 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 the 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 Investigators contact details are provided in the clinical trial specific information leaflet, or they can be contacted via the CliniSafe clinical trial site. Contact details for CliniSafe clinical trial sites are available at the following web address: https://researchforyou.co.uk/clinical-trial-centre-locations/.

If you wish to exercise any of these rights, please contact our Data Protection Officer using the details shown in the section titled “Inquiries, Complaints and Requests to Exercise Rights” below.

Information Security

CliniSafe maintains wide-ranging information security policies to apply technical and organisational security measures appropriate to the risk to the personal information We process. This is to ensure We protect sensitive and personal information that participants provide to Us (particularly sensitive clinical data), against unauthorized access or loss. CliniSafe’s security breach policy provides a procedural response for managing any breach of personal information, including making necessary notifications to individuals or governmental authorities.

Depending on which country personal data is collected or received from will decide which servers are used to store personal data. In the UK CliniSafe stores information on its own servers or on third-party servers (which may be in a different country) and personal data is transferred and stored in accordance with applicable Laws. All data stored are downloaded by CliniSafe personnel. CliniSafe uses commercial measures to ensure that your data is kept safe and treated in accordance with this Policy and applicable data protection and privacy Laws.

Worldwide Transfer of Personal Information: Personal information may be transferred to, stored, and processed in a country other than the one in which it was provided, including the U.S. (i.e., a ‘Recipient’ country). CliniSafe will use mechanisms for any such transfer as required under applicable Law. If you have questions concerning the transfer of your information, please contact Us using the contact details set out below.

Considerations When Online

The pages on CliniSafe’s websites may contain links to external websites, i.e. outside of the company. These external websites are not controlled, maintained, or endorsed by CliniSafe and may contain different information and/or different privacy policies from those of Our company. This Policy does not apply to linked websites outside the CliniSafe organisation. CliniSafe recommends that visitors review the privacy policy of each individually linked website before submitting any personal information. We do not accept any responsibility or liability for external/other websites’ privacy policies.

​Our web pages also use cookies. A cookie is a data file that is placed by a website operator on the hard drive of a visitor to their website. CliniSafe, and third parties with whom We work, may place cookies with the following functions on the computers of visitors to CliniSafe websites: to allow the site to deliver the service requested by the visitor; to remember repeat visitors; to improve the user experience of the site; to allow the company to perform site analytics; and to serve and help tailor Our marketing messages on our websites and elsewhere on the internet, based on the visitor’s previous browsing activity.

​The web browser and cookie settings on your electronic devices can be tailored to manage your online relationship with CliniSafe. At this time, We do not respond to “do not track” signals, however most web browsers will allow users to choose which cookies can be placed on their electronic device and to delete or disable cookies. Visitors should be aware that disabling cookies may prevent them from using certain features on CliniSafe websites. For more information, please see Our Cookie Policy.

The safety and security of information also depends on the individual providing the personal information:

If any individual chooses or are given a user identification code, password, or any other information as part of Our security procedures for one of the registration-only sections of the website, the individual is responsible for maintaining the confidentiality of their password and username for the website and the individual is responsible for all activities that are carried out under them. We will not be liable where the individual’s password or username is used by someone else. CliniSafe requires that the individual must notify Us immediately, at the contact information provided below, of any unauthorised use of the individuals password or username as soon as they become aware of such unauthorised use. We have the right to disable any user identification code or password, whether chosen by the individual or allocated by Us, at any time to safeguard the individuals account and data. Please be aware that while We take appropriate steps to safeguard the security of personal information, the transmission of information over the Internet is not completely secure and therefore the individual that discloses personal information does this at their own risk.

Children’s Online Privacy Protection

This website is not intended for, or designed to attract, individuals under the age of 18. CliniSafe does not collect information through our websites from individuals who are known to be under the age of 13, and no part of our online presence is directed to anyone less than 13 years. If you are a parent or guardian and you are aware that your child has provided Us with personal information, please 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, CliniSafe Finance Limited, Kaman Court, 1 Faraday Way, Blackpool, Lancashire, FY2 0JH, United Kingdom, (“DPO”).

Within UK individuals have the right in law to complain about how their information is managed to a supervisory authority that is responsible for regulating compliance with the Regulation. The following URL links to the relevant authority https://ico.org.uk/make-a-complaint/your-personal-information-concerns/.

Legal Status of Policy and Policy Changes

This Policy is not a contract, and it does not create any legal rights or obligations. CliniSafe 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://clinisafe.com/home/privacy-policy and https://researchforyou.co.uk/privacy-policy/ (Last Updated: 21st May 2024). Changes and additions to this Policy are effective from the date on which they are posted. Please review the privacy Policy from time to time to check whether We have made any changes to the way in which We use personal information. You may request previous versions of the Privacy Policy from the DPO.

We reserve the right to take any appropriate legal action, including referral to law enforcement, for any illegal or unauthorised use of this website. We also reserve the right take any action to prevent the unauthorised use of Our intellectual property.

Privacy Policy for www.clinisafe.com

This website www.clinisafe.com does not use store data.

Privacy Policy for secure.clinisafe.com

The main website for undertaking Drug Checking is secure.clinisafe.com

This secure drug checking website has it's own Privacy Policy. To view it click here.

Privacy Policy updated Feb 2019.