Privacy Policy

The Bionical Emas Group comprises Bionical Limited (a UK company) and its subsidiaries, which include but are not limited to, Bionical Emas, Inc. (US company), Bionical Emas Limited (Irish company) and Emas Pharma Limited (UK company, which manages clinical trials). All Bionical Emas companies use the Bionical Emas trade name. Together, the companies comprising the Bionical Emas Group are referred to in this Privacy Statement as Bionical Emas.

Bionical Emas is a CRO (Contract Research Organisation), providing clinical research services to its global pharmaceutical and biotech clients, along with businesses in related fields (Bionical Emas clients being referred to in this Privacy Statement as Clients).

This Privacy Statement relates to all of Bionical Emas’s services (which are referred to in this Privacy Statement as Bionical Emas Services). Bionical Emas Services include but are not limited to:

• Supply of comparator and related pharmaceutical products to Clients for use in clinical trials (referred to in this Privacy Statement as Clinical Trials Supply or CTS)
• Conduct/management of clinical trials on behalf of Clients, which includes handling of site requests, data management and Pharmacovigilance (as defined below). These Bionical Emas Services are referred to in this Privacy Statement as Clinical Trial Services
• Management of early access programs, also known as expanded access programs, or compassionate use programs (together referred to in this Privacy Statement as EAP Services). EAP Services involve the supply of unlicensed medicines to eligible patients, via their healthcare professionals, in circumstances where the patient has exhausted all available licensed treatment options (and in certain other limited situations prior to the pharmaceutical product becoming licensed). It involves supply of the applicable product to the applicable healthcare site, handling of access requests, data management and Pharmacovigilance (as defined below)
• Pharmacovigilance services, either as part of Clinical Trial Services or EAP Services, or as a standalone service (together referred to in this Privacy Statement as Pharmacovigilance). Pharmacovigilance is the monitoring of Adverse Events relating to use of healthcare treatments, including pharmaceutical products. Adverse Events are defined as unwanted or unexpected reactions experienced by a patient undergoing healthcare treatment. Bionical Emas Services such as Clinical Trial Services or EAP Services generally include managing and reporting of Adverse Events to our Clients, so that our Clients can discharge their Pharmacovigilance obligations. Bionical Emas also provides standalone Pharmacovigilance services for Clients in relation to medicinal products, including for products after the clinical trials stage when the pharmaceutical product is licensed for use in the applicable jurisdiction. This is required because people vary in their biological reactions to medicines. Clinical trials are comprehensive and will detect many potential adverse events. But not all such adverse reactions can be detected during the clinical trial stage, and accordingly, safety of medicines continues to be monitored when the medicine is licensed for use. Pharmacovigilance is important at all of these stages as it allows pharmaceutical companies and regulatory authorities worldwide to fully understand the Adverse Event profile of medicines, and to protect public health and ensure high standards of safety are achieved
• Real world data studies (referred to in this Privacy Statement as Real World Data Services). Real world data refer to observational data as opposed to data gathered in an experimental setting such as a controlled clinical trial
• Consulting projects relating to various elements of pharmaceutical product development.
• Communications with users of our websites or apps: for example, responding to enquiries made via our websites.

Bionical Emas operates globally in this highly-regulated, safety-focused field. As a necessary element of providing the Bionical Emas Services, Bionical Emas carries out Data Activities.

Bionical Emas engages a number of different types of specialist suppliers to aid it in providing the Bionical Emas Services. Such Bionical Emas suppliers are referred to in this Privacy Statement as Vendors.

In almost all cases where we supply Bionical Emas Services to a Client, the applicable Client is considered to be the ‘controller’ of the Personal Data collected (for the purposes EU and UK data protection law), with Bionical Emas and its Vendors being considered to be ‘processors’ (or ‘sub-processors’) of such Personal Data. However, where Personal Data is collected by Bionical Emas for its own business uses and not on behalf of a Client, Bionical Emas is usually considered to be the ‘controller’ of such Personal Data. This Privacy Statement applies to all Personal Data processed by Bionical Emas, whether Bionical Emas is controller or processor (where those concepts apply).

Please read this Privacy Statement before using Bionical Emas Services or submitting Personal Data to Bionical Emas. By accessing and using any of our Bionical Emas Services, you agree and consent to the collection, use and disclosure of your Personal Data as outlined in this Privacy Statement.

For ease of use, this Privacy Statement is provided in a layered format so you can click through to the specific areas set out below. Alternatively, you can download a pdf version of the Privacy Statement.

It is important that you read this Privacy Statement together with any other privacy or fair processing notice, or consent form (where applicable), that may be provided to you in specific circumstances, so you are fully aware of how and why we use your Personal Data. This Privacy Statement supplements such other notices/forms and does not override them.

Bionical Emas collects Personal Data (or Personal Data is collected on behalf of Bionical Emas) in several different ways and from several different sources, to enable us to provide the Bionical Emas Services, as follows:

• Directly from individuals (for example, by individuals using our website or our mobile apps to make enquiries, and supplying contact details)
• From healthcare professionals (who may inform us about themselves and/or patients), particularly in performance of Clinical Trial Services, EAP Services, Pharmacovigilance and Real World Data Services
• From Clients, in connection with our performance of Bionical Emas Services for them
• From other CRO’s we are working with, from clinical trial investigators, from Vendors, and from other third parties engaged by our Client who we interact with in provision of a Bionical Emas Service
• From or about individuals applying to be, or who have been, enrolled onto clinical trials, as part of our Clinical Trials Services
• From or about individuals applying to be included, or participating, in our EAP Services
• From other business partners
• From government agencies or public records
• From industry and patient groups and associations

From time to time, we may also use or augment the Personal Data we have about you with information obtained from other sources, such as public databases, social media platforms and other third parties. For example, we may use such third party information to confirm or verify healthcare professionals’ licences or to better understand your requirements by associating demographic information with the information you have provided.

Bionical Emas may also share your Personal Data with some or all of the parties or entities mentioned in the above list, as part of its legitimate Data Activities. Further information on the sharing of Personal Data is set out below.

We may collect, use, store and/or transfer (together referred to in this Privacy Statement as Processing) different kinds of Personal Data about you.

You should note that in relation to certain of our Data Activities, we are likely to collect and Process what in the UK is called sensitive Personal Data. Sensitive Personal Data includes data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, data concerning a person’s sex life or sexual orientation, and health-related data (together referred to in this Privacy Statement as Sensitive Personal Data). In our case, we are most likely to collect health-related Sensitive Personal Data, potentially including genetic and biometric data, in relation to the Bionical Emas Services. We will only Process such Sensitive Personal Data if we need to do so to provide the applicable Bionical Emas Service to you or to discharge our obligations to our applicable Client or to comply with applicable law.

We have grouped together the types of Personal Data we collect (dependent on the applicable Bionical Emas Service), some of which is Sensitive Personal Data, as follows:

• Contact information and contact preferences (such as name or initials, email address, mailing address, phone number, and emergency contact information)
• Biographical and demographic information (such as date of birth/age, marital status, professional/employment status and type, gender, ethnicity and sexual orientation)
• Health and medical information (such as information about physical and mental health conditions and diagnoses, weight, treatments for medical conditions, genetic information, family medical history, medications an individual may take, including the dosage, timing, and frequency, and Adverse Events suffered), which we Process where necessary in connection with the Bionical Emas Services, including the Clinical Trials Services, the EAP Services, Pharmacovigilance and Real World Data Services
• Information regarding any parents or legal guardians
• Financial information, for example to complete a transaction or determine eligibility for patient assistance programs
• Username and password that you may select in connection with establishing an account on our websites or mobile apps
• Your photograph, social media handle or digital or electronic signature
• Publicly available information
• Internet activity, such as your browsing history, your search history, and information on your interaction with the Bionical Emas Services
• We may use the Personal Data we collect about you with information obtained from other sources, such as public databases, social media platforms and other third parties

If you are a healthcare professional, Bionical Emas may also collect or share, in accordance with this Privacy Statement:

• Professional credentials, educational and professional history, institutional and government affiliations, and information included on a resume or curriculum vitae (such as work experience, education, and languages spoken)
• Information about the Bionical Emas Services with which you have engaged
• Details about our interactions with you, your use of Client products via the Bionical Emas Services and the agreements you have executed with us
• Publicly-available information related to your practice, such as licence information, disciplinary history, prior litigation and regulatory proceedings, and other due diligence related information.

Bionical Emas Processes Personal Data only where it has a legal basis for doing so in the applicable jurisdiction. Such legal basis may include:

• The Processing being in Bionical Emas’s legitimate interest in providing you with access to the applicable Bionical Emas Services
• The Processing being necessary for the performance of a contract between you and a Bionical Emas company
• The Processing being necessary for the performance of a contract, concluded in your interest, between a Bionical Emas company and a third party, such as a Client
• The Processing is necessary, or legally required, on important public interest grounds, for the establishment, exercise, or defence of legal claims, or to protect your vital interests
• Where the Processing is necessary for our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests
• The Processing is required by applicable law
• With your consent (where such consent is required and given) as described in specific terms, privacy notices and/or consent forms. Where Bionical Emas relies on consent, the opportunity to give that consent will be provided prior to the Personal Data in question being collected. Your consent is valid only if given by yourself or through your authorised representative such as a legal guardian, agent, or holder of a power of attorney. Where Bionical Emas relies on consent, you may be entitled to withdraw that consent (in relation to future Processing only).

You should note that we may share your Personal Data with a limited number of other parties. For example, we may report the information to our appropriate Client, and we may share the information with appropriate Vendors, in order to perform the applicable Bionical Emas Services. Examples follow:

Within Bionical Emas’s group of companies

In the normal course of performing the Bionical Emas Services, Personal Data may be shared within the Bionical Emas Group for research and statistical purposes, drug safety and efficacy purposes, disease management, system administration and crime prevention or detection, or any purpose otherwise identified in this Privacy Statement.

With our Clients

We may share your Personal Data with our applicable Client, in order for such Personal Data to be used for the benefit of the applicable project (for example, a clinical trial or an EAP), and for research and statistical purposes, drug safety (for example, Pharmacovigilance projects) and efficacy purposes, disease management, system administration and crime prevention or detection, or any purpose otherwise identified in this Privacy Statement.

With our Vendors and other third parties

As mentioned elsewhere in this Privacy Statement, we may retain Vendors to perform elements of the Bionical Emas Services on our behalf and we may collaborate with other companies, regulatory authorities (or similar) and individuals with respect to the Bionical Emas Services. Examples of our Vendors include data analysis firms, consultants working with us to provide Bionical Emas Services, companies providing us with warehouse and distribution services (for CTS or EAP Services, for example), companies providing services related to the provision of Clinical Trial Services or EAP Services (including but not limited to homecare services in respect of remote clinical trials/EAPs), credit card processing companies, customer service and support providers, email and SMS vendors, web hosting and development companies and fulfilment companies. Some Vendors may collect Personal Data on our (or our Clients’) behalf. We endeavour to ensure all Vendors and other third parties respect the security of your Personal Data and treat it in accordance with law. We do not allow our Vendors to use your Personal Data for their own purposes and only permit them to Process your Personal Data for specified purposes and in accordance with our (or our applicable Client’s) instructions.

Through our websites or apps, we may provide links to other websites, services, and applications that are not operated or controlled by us. This Privacy Statement does not apply to the websites or other platforms of such third parties. While we attempt to facilitate access only to those third party services that share our respect for your privacy, we cannot take responsibility for the content, privacy policies, or practices of those third parties. We encourage you to review and understand the privacy practices of any third party before providing any information to or through them. Your interactions with these third parties are governed by the privacy policy of the third party.

In connection with business transactions

As we continue to develop our business, we might sell or buy assets. In such transactions, user information, including Personal Data, may be one of the transferred business assets. Also, if either Bionical Emas itself or substantially all of Bionical Emas’ assets were to be acquired by another party, your Personal Data may be one of the transferred assets. Therefore, we may disclose and/or transfer your Personal Data to such third party in these circumstances.

To comply with our legal obligations

Bionical Emas reserves the right to disclose, without your prior permission, any Personal Data about you or your use of the Bionical Emas Services in circumstances where we have a good faith belief that such action is necessary to: (a) protect and defend the rights, property or safety of Bionical Emas, our employees, other users of the Bionical Emas Services, or the public; (b) enforce the terms and conditions that apply to use of the Bionical Emas Services; (c) as required by a legally valid request from a competent governmental authority and/or to comply with a judicial proceeding, court order, or legal process; or (d) respond to claims that any content violates the rights of third parties. We may also disclose Personal Data as we deem necessary to satisfy any applicable law.

Please be aware that we may also disclose to third parties, for any purpose, aggregated de-identified (anonymised) data that is not personally identifiable.

However, it should be noted that Bionical Emas does not sell Personal Data to third parties.

Your data may be collected and Processed in any country or jurisdiction in which you access our services. Privacy law varies in different countries, but Bionical Emas will always comply with the privacy law prevailing and which applies to you, wherever you may be in the world.

Bionical Emas maintains servers and other storage facilities in the United States, the EU, and the UK. Bionical Emas may transfer Personal Data outside of its country of origin for the purposes and in the manner set out in this Privacy Statement, including for Processing by Clients, Vendors, other appropriate third parties and Bionical Emas companies in connection with such purposes. In all situations, Bionical Emas takes reasonable steps to ensure that your privacy is protected. Such steps include, but are not limited to, implementing privacy, security, and contractual controls, as well as steps noted in this Privacy Statement, and steps as required by applicable law.

Where Personal Data is sent outside of the individual’s country, it may be subject to the laws of the country in which it is held, and may be subject to disclosure to the governments, courts, or law enforcement or regulatory agencies of such other country, pursuant to the laws of such country.

Bionical Emas endeavours to obtain assurances from its Vendors that they will safeguard Personal Data consistent with this Privacy Statement. An example of appropriate assurances that may be provided by Vendors includes a contractual obligation that they provide at least the same level of protection as is required by Bionical Emas’s privacy principles set out in this Privacy Statement. Where Bionical Emas becomes aware or suspects that a Vendor is using or disclosing Personal Data in a manner contrary to this Privacy Statement, Bionical Emas will take appropriate steps to prevent or stop the use or disclosure.

If you are an EEA or UK citizen and/or accessing Bionical Emas websites in the EEA or the UK, then this paragraph may apply in addition to the above. Transfers of your Personal Data may be made to entities located outside the EEA/UK, including entities located in the United States, for Processing consistent with the purposes described in this Privacy Statement. Bionical Emas will implement appropriate contractual measures (including standard contractual data protection clauses, a copy of which you can obtain by contacting Legal@Bionical-emas.com), and other security measures where applicable, to ensure that the relevant Bionical Emas companies and third parties (Clients, Vendors etc) outside the EEA/UK provide an adequate level of protection for your Personal Data as set out in this Privacy Statement and as required by applicable law.

Bionical Emas has implemented reasonable physical, technical, organisational and managerial controls and safeguards to keep your Personal Data protected from unauthorised access, disclosure, alteration, and destruction. Such measures may include but are not limited to:

• the encryption of communications via SSL
• encryption of information whilst it is in storage
• firewalls
• access controls
• separation of duties of staff
• pseudonymisation (where appropriate)
• use only of properly validated software systems

Bionical Emas trains its personnel on the importance of privacy and how to handle and manage Personal Data appropriately and securely. All employees and consultants are subject to a duty of confidentiality. Bionical Emas maintains physical, electronic and procedural measures to safeguard Personal Data from accidental or unauthorised access, use, disclosure, or deletion. Personal Data handled by Vendors or companies with which Bionical Emas may conduct joint programs, is governed by this Privacy Statement.

However, it should be noted that the confidentiality of Personal Data transmitted over the internet cannot be guaranteed. Bionical Emas urges you to exercise caution when transmitting Personal Data over the internet. Bionical Emas cannot absolutely guarantee that unauthorised third parties will not gain access to your Personal Data. Therefore, when submitting Personal Data to Bionical Emas online, you must consider both the benefits and the risks of doing so.

We will use Personal Data only in ways that are compatible with the purposes for which they were collected or consented to by the individual (where applicable), unless we reasonably consider that we need to use the information for another reason and that reason is compatible with the original purpose.

Bionical Emas has appropriate steps in place to ensure that Personal Data is relevant to its intended use, and is accurate, complete, and current.

Bionical Emas will only retain Personal Data for as long as it is needed to fulfil the purposes for which it was collected, subject to applicable data retention periods imposed upon Bionical Emas by applicable law. This may mean that your Personal Data is stored by Bionical Emas or its Vendors or Clients for a number of years, depending on the purpose and need for that Personal Data to be processed. For more information about Bionical Emas’s retention periods for Personal Data, please refer to the Contacts section below. You should also note that retention periods for Personal Data related to Bionical Emas Services, including Pharmacovigilance, Real World Data Services, Clinical Trial Services and EAP Services may be lengthy. These requirements are mandatory, for the purpose of safety, and may include retention for the duration of the applicable product’s life-cycle and an additional 10 years after the medicine has been removed from the market.

Bionical Emas does not intend to collect any Personal Data from children on Bionical Emas websites or apps (children being individuals who have not reached the age of majority in their residential jurisdictions).

Where children are eligible for/applicable to the Bionical Emas Services (for example, sometimes in respect of Clinical Trial Services, EAP Services, Real World Data Services or Pharmacovigilance), their applicable Personal Data may be Processed. However, Bionical Emas does not knowingly allow children to communicate directly with Bionical Emas. Should you suspect that a child of whom you are the parent or legal guardian has provided us with Personal Data directly, please contact Bionical Emas using one of the methods set out at the Contacts section below, and Bionical Emas will work with you to address this issue.

You have certain rights and choices regarding our (and our applicable Client’s and Vendors’) Processing of your Personal Data. Depending on your jurisdiction and the purposes for which the Personal Data is Processed, applicable law may entitle you to additional consumer rights, including the right to:

• Know the categories of and/or specific pieces of information regarding the Personal Data collected about you, including whether your Personal Data is sold or disclosed, and with whom your Personal Data is shared
• Access a copy of the Personal Data retained about you
• Request deletion of your Personal Data (but please note that we may not be lawfully permitted to delete Personal Data we have processed, for example for Clinical Trial Services, EAP Services, Real World Data Services or Pharmacovigilance purposes)
• Correct or amend your Personal Data
• Request transfer of your Personal Data to you or another person in a commonly utilisable format
• Object to certain uses of your Personal Data
• Where we are relying on consent to process your Personal Data, you may usually withdraw your consent at any time. However, this will not affect the lawfulness of any processing carried out before you withdraw your consent. If you withdraw your consent, we may not be able to provide certain Bionical Emas Services to you. We will advise you if this is the case at the time you withdraw your consent.
• File a complaint with an appropriate data protection authority. For the UK, this is the Information Commissioner’s Office (ICO) at www.ico.org.uk. We would however always appreciate the chance to deal with your concerns before you make such a complaint, so please do contact us in the first instance at DISTDPO@bionical-emas.com.

We reserve the right to verify your identity in connection with any requests regarding Personal Data to help ensure that we provide the Bionical Emas Services to the individual to whom it pertains and allow only those individuals or their authorised representatives to exercise rights with respect to that information. If you are an authorised agent making a request on behalf of an individual, we may require additional information to verify that you are authorised to make that request. This may include obtaining a written authorisation and proof that you are authorised to make the request.

Bionical Emas may not be able to comply with a request where Personal Data has been destroyed, erased or made anonymous in accordance with Bionical Emas’s record retention obligations and practices. In the event that Bionical Emas cannot provide an individual with access to his/her Personal Data, Bionical Emas will endeavour to provide the individual with an explanation, subject to any legal or regulatory restrictions.

Any questions or concerns regarding this Privacy Statement, the Processing of Personal Data by Bionical Emas, or related to revocation of consent to Process your Personal Data (where applicable), or any other of your data protection rights, should be directed to the contact address set out below. To submit a request to us, please contact us at: DISTDPO@bionical-emas.com, or by mail to the following address:

FAO The Data Protection Officer
Bionical Limited trading as Bionical Emas
The Piazza, Mercia Marina
Findern Lane, Willington
Derbyshire DE65 6DW
United Kingdom

In relation to the processing of Personal Data of EEA citizens, Bionical Emas has appointed an EEA-resident data protection representative responsible for overseeing our compliance with EU data protection law, whom you may contact at EUDPO@bionical-emas.com if you have any questions or concerns regarding the Processing of your Personal Data. If Bionical Emas’s Processing of your Personal Data is covered by EU law you may also lodge a complaint with the corresponding data protection supervisory authority in your country of residence. You can find the relevant supervisory authority name and contact details under
http://ec.europa.eu/justice/data-protection/bodies/authorities/index_en.htm.

To help us respond to your request, all communications should include the sender’s name and contact information (such as e-mail address, phone number or mailing address), and a detailed explanation of the request. In addition, communications related to Bionical Emas websites should include, as applicable, the e-mail address used for registration and the Bionical Emas website address on which Personal Data was provided. E-mail requests to delete, amend, or correct Personal Data should include “Deletion Request” or “Amendment/Correction Request”, as applicable, in the subject line of the e-mail or header of the letter, as applicable. Bionical Emas will endeavour to respond to all reasonable requests in a timely manner (generally, one month in the UK), and in any case, within any time limits prescribed by applicable local law. If we cannot meet these timelines, we will notify you and keep you updated.

We will not usually charge a fee to access your Personal Data, or to exercise any of the other rights. However, we may charge a reasonable fee if your request is clearly unfounded, repetitive or excessive. Alternatively, we could refuse to comply with your request in these circumstances. We will endeavour not to restrict or deny you access to our Services because of choices and requests you make in connection with your Personal Data. However, please note that certain choices may affect our ability to deliver Bionical Emas Services to you.

Any requests to opt-out of future communications from Bionical Emas or to opt-out of a particular Bionical Emas program should be directed to Bionical Emas using the contact methods above.

Bionical Emas keeps its data protection/privacy arrangements under review, and accordingly reserves the right to amend this Privacy Statement from time to time to reflect technological advancements, legal and regulatory changes and/or changes to Bionical Emas’s business practices, subject to applicable laws. If Bionical Emas changes its privacy practices, an updated version of this Privacy Statement will reflect those changes. Bionical Emas will provide notice of such changes by updating the effective date listed on this Privacy Statement. It is your responsibility to check this Privacy Statement frequently on our website to view any amendments. Your continued interaction with Bionical Emas will, in respect of Data Activity, be subject to the then-current Privacy Statement.

It is of course important that the Personal Data we hold about you is accurate and current. Please keep us informed if your Personal Data changes during your relationship with us.