Last Updated: 26th September 2023
Thank you for choosing to be part of our community at Clinical Consulting Services, LLC, trading as CCS ("CCS", "we", "us", "our"). We are committed to protecting your personal information and your right to privacy. If you have any questions or concerns about this privacy notice, or our practices with regards to your personal information, please contact us at firstname.lastname@example.org.
General Data Protection Regulation (GDPR) – European Representative: Pursuant to Article 27 of the General Data Protection Regulation (GDPR), CCS has appointed European Data Protection Office (EDPO) as its GDPR Representative in the EU. You can contact EDPO regarding matters pertaining to the GDPR:
When you visit our website http://www.efzofit.com (the "Website"), and more generally, use any of our services (the "Services", which include the Website), we appreciate that you are trusting us with your personal information. We take your privacy very seriously. In this privacy notice, we seek to explain to you, in the clearest way possible, what information we collect, how we use it and what rights you have in relation to it. We hope you take some time to read through it carefully, as it is important. If there are any terms in this privacy notice that you do not agree with, please stop using our Services immediately.
This privacy notice applies to all information collected through our Services (which, as described above, includes our Website), as well as any related services, sales, marketing or events.
Please read this privacy notice carefully as it will help you understand what we do with the information that we collect.
aTyr Pharma, Inc. (“aTyr”) and its authorised vendors are committed to protecting and respecting your privacy in the processing of data related to the use of the Website https://www.efzofit.com (the “EFZO-FIT study website”). This study specific Website is dedicated to patient recruitment. CCS is the party responsible for creating the EFZO-FIT study website and will perform secondary screening in Germany, the Netherlands and the United Kingdom for patients referred from the EFZO-FIT study website to clinical study sites. CCS will therefore process your personal data as a Processor acting on behalf of aTyr (as Sponsor of the EFZO-FIT study) for this specific purpose.
1. Who is aTyr Pharma?
aTyr’s mission is to translate findings from its tRNA synthetase platform into new therapeutics for fibrosis, inflammation and cancer. Efzofitimod is a first-in-class biologic based on a naturally occurring, lung-enriched splice variant of histidyl-tRNA synthetase (HARS) that downregulates immune responses via selective modulation of neuropilin-2 (NRP2). aTyr is developing efzofitimod as a potential disease-modifying therapy for patients with interstitial lung disease (ILD), a group of rare immune-mediated disorders that can cause progressive fibrosis of the lung. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, the most prevalent form of ILD. aTyr is currently investigating efzofitimod in patients with pulmonary sarcoidosis in a global Phase 3 study known as EFZO-FIT™.
2. Information on the processing of your personal data
|What type of data will be collected?
|For which purposes?
|On which legal basis?
|Your responses provided to health status questions, your name and contact information.
|Recruitment of patients to the EFZO-Fit study through a pre-screening questionnaire. The questionnaire will later be reviewed by a doctor to ascertain eligibility to participate in the study.
Personal information you disclose to us
In short: We collect personal information that you provide to us.
We collect personal information that you voluntarily provide to us when you express an interest in obtaining information about us or our products and Services, when you participate in activities on the Website or otherwise when you contact us.
The personal information that we collect depends on the context of your interactions with us and the Website, the choices you make and the products and features you use. The personal information we collect may include the following:
Personal Information Provided by You. We collect names, phone numbers; email addresses; postal addresses; contact preferences; health information; and other similar information.
On some Website pages and apps, you can register to receive customised information. This information is generally collected on ‘Contact Us’ forms where you may choose to be contacted by CCS. The personal information collected in these cases include your name, title, company, address, contact details and e-mail address.
All personal information that you provide to us must be true, complete and accurate, and you must notify us of any changes to such personal information.
Information collected automatically.
In short: Some information — such as your Internet Protocol (IP) address and/or browser and device characteristics — is collected automatically when you visit our Website.
We automatically collect certain information when you visit, use or navigate the Website. This information does not directly reveal your specific identity (like your name or contact information) but may include device and usage information, such as your IP address, browser and device characteristics, operating system, language preferences, referring URLs, device name, country, location, information about how and when you use our Website, and other technical information. This information is primarily needed to maintain the security and operation of our Website, and for our internal analytics and reporting purposes.
Like many businesses, we also collect information through cookies and similar technologies.
The information we collect includes:
Log and Usage Data. Log and usage data is service-related, diagnostic, usage and performance information our servers automatically collect when you access or use our Website and which we record in log files. Depending on how you interact with us, this log data may include your IP address, device information, browser type and settings and information about your activity in the Website (such as the date/time stamps associated with your usage, pages and files viewed, searches and other actions you take such as which features you use), device event information (such as system activity, error reports [sometimes called 'crash dumps'] and hardware settings).
Device Data. We collect device data, such as information about your computer, phone, tablet or other device you use to access the Website. Depending on the device used, this device data may include information such as your IP address (or proxy server), device and application identification numbers, location, browser type, hardware model Internet service provider and/or mobile carrier, operating system and system configuration information.
Location Data. We collect location data such as information about your device's location, which can be either precise or imprecise. How much information we collect depends on the type and settings of the device you use to access the Website. For example, we may use GPS and other technologies to collect geolocation data that tells us your current location (based on your IP address). You can opt out of allowing us to collect this information either by refusing access to the information or by disabling your Location setting on your device. Please Note, however, that if you choose to opt out, you may not be able to use certain aspects of the Services.
In addition, we do collect data via social media channels such as Twitter, Facebook and YouTube but it is limited to aggregate data for statistical analysis. If data is collected in conjunction with a clinical trial, it is only used upon the consent of the subject and for the explicit purpose of participating in a clinical trial, and shall be destroyed upon request.
In short: We process your information for purposes based on legitimate business interests, the fulfilment of our contract with you, compliance with our legal obligations and/or your consent.
We use personal information collected via our Website for a variety of business purposes described below. We process your personal information for these purposes in reliance on our legitimate business interests, in order to enter into or perform a contract with you, with your consent, and/or for compliance with our legal obligations. The specific processing grounds we rely on are shown next to each purpose listed below.
Investigators, clinical site study team members and other healthcare professionals (HCPs)
We collect the names, contact details and professional information of clinical trial investigators, study researchers and other HCPs for the purpose of identifying and assessing suitability to assist in clinical trials and research studies and to provide Services. We collect your personal data when you provide it to us directly, for example, when you express or register an interest to participate in a study through our Websites, and also, either directly or indirectly, from publicly available sources, such as websites, directories and industry networks, etc. For further information on our collection activities and uses of personal information through our Websites, please refer to “Website Visitors and Mobile Application Users”. If you subsequently participate in a trial or study CCS manages or provides services for, we will also collect information relating to the involvement and performance of HCPs. Further information is available in our Site Data Protection Notice and Consent Form available here.
Study Participants in Studies sponsored by CCS clients.
CCS is a global Patient Recruitment Organisation that provides services to support the clinical trials and medical research studies of Sponsors or CROs. Depending on the Recruitment services CCS is providing to a Sponsor or CRO, we process personal data relating to study participants on behalf of our Sponsors and in accordance with contracts with and instructions from the Sponsor. CCS may also, to the extent necessary, process personal data relating to study participants’ spouses, partners, carers and relatives if they are involved in the participants’ participation in a study; e.g., parents involved in decision making of child participants or spouses involved in the care of an incapacitated participant.
In relation to CCS’ delivery of Patient Recruitment services to Sponsors, the Sponsor is in control of how and why your personal data is processed and as such is the “Controller”, while CCS is a “Data Processor”. CCS’ role as Processor may include the transfer of such personal information to the applicable Sponsor, its corporate affiliates, business partners and third-party service providers performing services related to the study.
The purposes for which study participant personal data will be used by Sponsors and CCS will depend on the nature of the Sponsor’s study and will be addressed in study-specific documentation, and in particular in study participant consent documentation that is reviewed prior to participation in a study. As such, study participants should look to that documentation to understand how their personal data is processed in relation to a study. To provide a general overview, personal data will typically be processed for the purposes of assessing eligibility to participate in a study, administering the study, monitoring the study, analysing data to assess the overall safety and effectiveness of the therapy that is the subject of the study, and drawing conclusions regarding the effectiveness and viability of the therapy that is the subject of the study.
The method we will use to obtain this data is via our study screeners that are part of the study Website. Additionally, we may obtain information via healthcare events organised to disseminate information about this trial.
Participants in CCS Patient Databases
Certain CCS Services involve the development and maintenance of databases of persons who may be eligible and may wish to participate in clinical trials and medical research studies (“Patient Recruitment Databases”) managed by Sponsors. Once a person is recorded in CCS’ Patient Recruitment Databases, CCS may contact them, as Controller, for further screening, and may refer them to potentially suitable clinical trials or research studies matched to their areas of medical interest.
In order to match such persons’ entered into Patient Recruitment Databases to appropriate clinical trials or research studies, CCS will, on a need-to-know basis, request, collect and process suitable personal data on the basis of the person’s explicit consent, such as names, addresses and contact information, which may be collected on voice recordings, as well as sensitive personal information.
Examples of sensitive personal data we collect include:
Your personal information may be collected either by volunteering it through one of our Websites, or in a live interview or screening telephone call or meeting with CCS representatives. Please be aware that by providing your personal information, you consent to a member of our team contacting you directly by way of following-up with you, including contacting you directly by telephone or other means, including SMS text messages, and adding your personal information to our Patient Recruitment Databases.
In this context, CCS is the controller of the personal data
Uses of your personal data. As discussed earlier, the main purpose of collecting personal data in Patient Recruitment Databases is to match patients to suitable clinical trials and research projects based on the individuals’ areas of medical interest. For example, if an individual with Alzheimer’s expresses a desire to participate in clinical research or avail themselves of novel treatments for Alzheimer’s or associated symptoms:
CCS may use your personal information to respond to subsequent requests you may ask of us, and from time to time we may refer to your personal information to better understand your needs and how we can improve our Websites, products and Services on the basis of our legitimate interests in doing so. We may enhance or merge your personal information with data obtained from third parties for the same purposes. Any other information transferred by you that cannot be used to identify you (and which, therefore, does not constitute personal information) may be included in databases owned and maintained by CCS. CCS may also use anonymised personal data to run general statistical analysis in support of patient recruitment and similar analytical purposes.
In short: We only share information with your consent, to comply with laws, to provide you with Services, to protect your rights, or to fulfil business obligations.
Your data may be shared with the following categories of recipients:
We may process or share your data that we hold based on the following legal basis:
Consent: We may process your data if you have given us specific consent to use your personal information for a specific purpose. For the purpose of enrolling patients into a study, the information provided by the study subjects is used only upon their consent to send their information to the clinical sites to check their eligibility for a clinical trial.
Legitimate Interests: We may process your data when it is reasonably necessary to achieve our legitimate business interests, which include enrolling you in a clinical trial based upon the responses provided via the online form.
Performance of a Contract: Where we have entered into a contract with you, we may process your personal information to fulfil the terms of our contract, which is to check whether you are eligible for a particular trial based upon the responses provided.
Legal Obligations: We may disclose your information where we are legally required to do so in order to comply with applicable law, governmental requests, a judicial proceeding, court order or legal process, such as in response to a court order or a subpoena (including in response to public authorities to meet national security or law enforcement requirements).
Vital Interests: We may disclose your information where we believe it is necessary in the vital interest of the subject.
In short: We may transfer, store, and process your information in countries other than your own.
Our servers are located in the United States of America. If you are accessing our Website from outside the USA, please be aware that your information may be transferred to, stored and processed by us in our facilities and by those third parties with whom we may share your personal information (see "WILL YOUR INFORMATION BE SHARED WITH ANYONE?" above), in the USA and other countries.
If you are a resident in the European Economic Area, these countries may not necessarily have data protection laws or other similar laws as comprehensive as those in your country. However, we will take all necessary measures to protect your Personal Data in accordance with this privacy notice and applicable law.
European Commission's Standard Contractual Clauses:
We have implemented measures to protect your personal information, including by using the European Commission's Standard Contractual Clauses for transfers of personal information between our group companies and between us and our third-party providers. These clauses require all recipients to protect all personal information that they process originating from the EEA in accordance with European data protection laws and regulations. Our Data Processing Agreements that include Standard Contractual Clauses can be provided upon request/are available here. We have implemented similar appropriate safeguards with our third-party service providers and partners, and further details can be provided upon request.
WHAT INFORMATION DO WE COLLECT? To learn more about the types of personal data Clinical Consulting Services, LLC collects.
HOW DO WE USE YOUR INFORMATION? To learn more about the purposes for which Clinical Consulting Services, LLC collects and uses personal information about you.
WILL YOUR INFORMATION BE SHARED WITH ANYONE? To learn more about the type or identity of third parties to which Clinical Consulting Services, LLC discloses personal information, and the purposes for which we do so.
WHAT ARE YOUR PRIVACY RIGHTS? To learn more about the right of individuals to access their personal data.
In short: We keep your information for as long as necessary to fulfil the purposes outlined in this privacy notice, unless otherwise required by law.
We will only keep your personal information for as long as is necessary for the purposes set out in this privacy notice, unless a longer retention period is required or permitted by law (such as tax, accounting or other legal requirements).
When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymise such information, or, if this is not possible (for example, because your personal information has been stored in backup archives), we will securely store your personal information and isolate it from any further processing until deletion is possible.
The data retention period is based upon the purpose as outlined below:
Clinical Trial Recruitment:
In short: We aim to protect your personal information through a system of organisational and technical security measures.
We have implemented appropriate technical and organisational security measures designed to protect the security of any personal information we process. However, despite our safeguards and efforts to secure your information, no electronic transmission over the Internet or information storage technology can be guaranteed to be 100% secure, so we cannot promise or guarantee that hackers, cybercriminals, or other unauthorised third parties will not be able to defeat our security, and improperly collect, access, steal, or modify your information. Although we will do our best to protect your personal information, transmission of personal information to and from our Website is at your own risk. You should only access the Website within a secure environment.
In short: We do not knowingly collect data from, or market to, children under 18 years of age.
We do not knowingly solicit data from or market to children under 18 years of age. By using the Website, you represent that you are at least 18 years of age or that you are the parent or guardian of such a minor and consent to such minor dependent’s use of the Website. If we learn that personal information from users less than 18 years of age has been collected, we will deactivate the account and take reasonable measures to promptly delete such data from our records. If you become aware of any data we may have collected from children under 18 years of age, please contact us at email@example.com.
In short: In some regions, such as the European Economic Area, you have rights that allow you greater access to and control over your personal information. You may review, change or terminate your account at any time.
In some regions (like the European Economic Area), you have certain rights under applicable data protection laws. These may include the right (i) to request access and obtain a copy of your personal information, (ii) to request rectification or erasure; (iii) to restrict the processing of your personal information; and (iv) if applicable, to data portability, which allows individuals to obtain and reuse their personal data for their own purpose. In certain circumstances, you may also have the right to object to the processing of your personal information. To make such a request, please use the contact details provided below. We will consider and act upon any request in accordance with applicable data protection laws.
If we are relying on your consent to process your personal information, you have the right to withdraw your consent at any time. Please note, however, that this will not affect the lawfulness of the processing before its withdrawal, nor will it affect the processing of your personal information conducted in reliance on lawful processing grounds other than consent.
If you are a resident in the European Economic Area and you believe we are unlawfully processing your personal information, you also have the right to complain to your local data protection supervisory authority. You can find their contact details here: http://ec.europa.eu/justice/data-protection/bodies/authorities/index_en.htm.
If you are a resident in Switzerland, the contact details for the data protection authorities are available here: https://www.edoeb.admin.ch/edoeb/en/home.html.
Most web browsers and some mobile operating systems and mobile applications include a Do-Not-Track ("DNT") feature or setting you can activate to signal your privacy preference not to have data about your online browsing activities monitored and collected. At this stage, no uniform technology standard for recognising and implementing DNT signals has been finalised. As such, we do not currently respond to DNT browser signals or any other mechanism that automatically communicates your choice not to be tracked online. If a standard for online tracking is adopted that we must follow in the future, we will inform you about that practice in a revised version of this privacy notice.
In short: Yes, if you are a resident of California, you are granted specific rights regarding access to your personal information.
California Civil Code Section 1798.83, also known as the "Shine The Light" law, permits our users who are California residents to request and obtain from us, once a year and free of charge, information about categories of personal information (if any) we disclosed to third parties for direct marketing purposes and the names and addresses of all third parties with which we shared personal information in the immediately preceding calendar year. If you are a California resident and would like to make such a request, please submit your request in writing to us using the contact information provided below.
If you are under 18 years of age, reside in California, and have a registered account with the Website, you have the right to request removal of unwanted data that you publicly post on the Website. To request removal of such data, please contact us using the contact information provided below, and include the email address associated with your account and a statement that you reside in California. We will make sure the data is not publicly displayed on the Website, but please be aware that the data may not be completely or comprehensively removed from all our systems (e.g., backups, etc.).
The California Code of Regulations defines a "resident" as:
(1) every individual who is in the State of California for other than a temporary or transitory purpose and
(2) every individual who is domiciled in the State of California who is outside the State of California for a temporary or transitory purpose
All other individuals are defined as "non-residents."
If this definition of "resident" applies to you, we must adhere to certain rights and obligations regarding your personal information.
We have collected the following categories of personal information in the past twelve (12) months:
Contact details, such as real name, alias, postal address, telephone or mobile contact number, unique personal identifier, online identifier, Internet Protocol address, email address and account name
B. Personal information categories listed in the California Customer Records statute
Name, contact information, education, employment, employment history and financial information
C. Protected classification characteristics under California or federal law
Gender and date of birth
D. Commercial information
Transaction information, purchase history, financial details and payment information
E. Biometric information
Fingerprints and voiceprints
F. Internet or other similar network activity
Browsing history, search history, online behaviour, interest data, and interactions with our and other websites, applications, systems and advertisements
G. Geolocation data
H. Audio, electronic, visual, thermal, olfactory, or similar information
Images and audio, video or call recordings created in connection with our business activities
I. Professional or employment-related information
Business contact details in order to provide you our Services at a business level, job title as well as work history and professional qualifications if you apply for a job with us
J. Education Information
Student records and directory information
K. Inferences drawn from other personal information
Inferences drawn from any of the collected personal information listed above to create a profile or summary about, for example, an individual’s preferences and characteristics
We may also collect other personal information outside of these categories instances where you interact with us in-person, online, or by phone or post in the context of:
More information about our data collection and sharing practices can be found in this privacy notice.
You may contact us by email at firstname.lastname@example.org, or by referring to the contact details at the bottom of this document.
If you are using an authorised agent to exercise your right to opt-out, we may deny a request if the authorised agent does not submit proof that they have been validly authorised to act on your behalf.
We may disclose your personal information with our service providers, pursuant to a written contract between us and each service provider. Each service provider is a for-profit entity that processes the information on our behalf.
We may use your personal information for our own business purposes, such as for undertaking internal research for technological development and demonstration. This is not considered to be "selling" your personal data.
Clinical Consulting Services, LLC has not disclosed or sold any personal information to third parties for a business or commercial purpose in the preceding 12 months. Clinical Consulting Services, LLC will not sell personal information in the future belonging to Website visitors, users or other consumers.
You can ask for the deletion of your personal information. If you ask us to delete your personal information, we will respect your request and delete your personal information, subject to certain exceptions provided by law, such as (but not limited to) the exercise by another consumer of his or her right to free speech, our compliance requirements resulting from a legal obligation, or any processing that may be required to protect against illegal activities.
Depending on the circumstances, you have a right to know:
In accordance with applicable law, we are not obligated to provide or delete consumer information that is de-identified in response to a consumer request or to re-identify individual data to verify a consumer request.
We will not discriminate against you if you exercise your privacy rights.
Upon receiving your request, we will need to verify your identity to determine you are the same person about whom we have the information in our system. These verification efforts require us to ask you to provide information so that we can match it with information you have previously provided us. For instance, depending on the type of request you submit, we may ask you to provide certain information so that we can match the information you provide with the information we already have on file, or we may contact you through a communication method (e.g. phone or email) that you have previously provided to us. We may also use other verification methods, as the circumstances dictate.
We will only use personal information provided in your request to verify your identity or authority to make the request. To the extent possible, we will avoid requesting additional information from you for the purposes of verification. If, however, we cannot verify your identity from the information already maintained by us, we may request that you provide additional information for the purposes of verifying your identity, and for security or fraud-prevention purposes. We will delete such additionally provided information as soon as you have been verified.
In short: Yes, we will update this notice as necessary to stay compliant with relevant laws.
We may update this privacy notice from time to time. The updated version will be indicated by an updated "Revised" date, and the updated version will be effective as soon as it is accessible. If we make material changes to this privacy notice, we may notify you either by prominently posting a notice of such changes or by directly sending you a notification. We encourage you to review this privacy notice frequently to be informed of how we are protecting your information.
If you have questions or comments about this notice, you may contact our Data Protection Officer (DPO) by email at email@example.com, by phone on 866.277.4888 or by post to:
Clinical Consulting Services, LLC
Data Protection Officer
1099 Winterson Road, Suite 136
Linthicum, MD 21090
Based on the applicable laws of your country, you may have the right to request access to the personal information we collect from you, change that information or delete it in some circumstances. To request to review, update or delete your personal information, please submit a request form by clicking here. We will respond to your request within 30 days.