PCM Trials Privacy Statement

1. Who is PCM Trials?

PCM Trials is a division of Act for Health, Inc., which along with its affiliates (collectively, “PCM Trials”, “we”, “us” or “our”) provides mobile research services to accelerate drug development and make clinical studies available to a broader range of patients by bringing research to individuals whenever and wherever it is convenient for them.

We are headquartered in Denver, Colorado and are dedicated to offering our mobile research services around the world.

We value the privacy of every individual whose data we collect and adhere to the ethical and quality standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) for protecting the rights, safety and wellbeing of clinical trial participants and the integrity of clinical trial data in every aspect of the services that we provide.

We believe that privacy and clinical research can effectively co-exist to enrich and save lives.

2. List of PCM Companies

Entity	Country	Location / Contact Info
Act for Health, Inc	USA – Colorado	500 E. 8th Avenue Denver, CO 80203, United States Tel US: +1 888 886 2281 Outside US: +0011 1 888 886 2281
Professional Case Management Clinical Trials, LLC	USA – Colorado	500 E. 8th Avenue Denver, CO 80203, United States Tel US: +1 888 886 2281 Outside US: +0011 1 888 886 2281
PCM Clinical Trials International, LTD	UK	268 Bath Road Slough, SL1 4DX, United Kingdom Tel: +44 (0) 1753 299 999
PCM Clinical Trials Canada, ULC	Canada	500 E. 8th Avenue Denver, CO 80203, United States Tel US: +1 888 886 2281 Outside US: +0011 1 888 886 2281
Clinical Trial Service B.V.	The Netherlands	De Pol 23 7581 CZ Losser The Netherlands Tel: +31 (0) 53 5362220

3. Scope of This Privacy Statement

PCM Trials has established a comprehensive privacy program designed to help us respect and protect your privacy rights. Our privacy program adheres to the fundamental principles of the EU General Data Protection Regulation. When we use personal information about you (“Personal Data” or “Personal Information”), we use it in a reasonable and responsible way, minimizing the type of information we collect and hold about you, the period of time we store it, and the ways we use it. In this Privacy Statement, we refer to you as “you” or “your”. We use the terms “Process”, “Processing” or “Use” or “Using” when we refer to the access, collection, recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, disclosure, dissemination, transfer, deletion or otherwise use of your Personal Data.

This Privacy Statement concerns PCM Trials’ business operations including outreach, client onboarding, project management of mobile research visits, administration, and the use of our websites.

This Privacy Statement does not apply to Personal Data that we Process on behalf of our prospective, current, and former employees and independent contractors, which are covered in separate notices.

When Using your Personal Data in the context of our activities and operations, we will do so in compliance with relevant data privacy and protection laws and regulations that may apply to such Use, and where applicable, in accordance with specific privacy rights that may apply to you in the country or region in which you reside (“Applicable Data Protection Laws”).

4. Purpose

Our purpose of this Privacy Statement is to provide our current, former and potential clinical trials clients, clinical trial participants, other business partners, and website visitors with an understanding of:

How and why we collect your Personal Data;
The types of Personal Data we collect;
Who we share your Personal Data with;
How we Use, Process, share, store, and protect your Personal Data; and
Our contact details so you can request information about the Processing of your Personal Data and your rights to do so.

5. Types of Personal Data We Collect for Our Services and Why We Collect It

Website visitors

When you visit our website, we collect your contact and identity information such as your name, company title, postal address, email address, telephone number and company name and treat it as Personal Data. We collect this information if you communicate with us through the “Request for Proposal”, “Contact Us”, “Marketing Opt-in” or “Schedule 1-on-1” features on our website. We ask for your Personal Data so that we can verify your identity or respond to your questions or comments.

Please note that if you apply for a position via our “Careers” page you will be directed to a separate notice applicable to the processing of your Personal Information.

We also collect your internet and network activity information, which may include cookies, IP address, browser type, your internet service provider, referring/ exit pages, files viewed (HTML pages, graphics, etc.), operating system, date/time stamp, and clickstream data and treat it as Personal Data under certain data privacy laws. We use this information for website administration, record keeping, data analysis, testing, troubleshooting, trend (aggregate) monitoring, and website security.

Please read the section below regarding “Cookies and Automated Tracking Technologies” for more information.

Sponsors/ Contract Research Organizations (CROs)/ Clinical Trial Site Employees

When you are a prospective or current business partner of PCM Trials, we collect your contact and identity information such as your name, company name, title, postal address, email address, and phone number and treat it as Personal Data. We collect this information to communicate with you; to administer, manage, and improve our services including mobile research services; to provide you with relevant information and assistance on our products or services; and to manage our customer and business partner relationships.

Certified Mobile Research Nurses (CMRNs)

When you are a potential or current employee or independent contractor for PCM Trials we collect certain Personal Data from you for recruitment and staffing activities. You will receive a separate privacy notice that explains the Personal Data that we collect from you, how we Use that information and how we protect it.

Clinical Trial Participants

When you are participating in clinical trial research, we are collecting your Personal Data on behalf of our Sponsors. This Personal Data may include your contact and identity information such as your name, postal address, email address and phone number. This Personal Data may also include demographic information such as your age, gender, ethnicity, or race, and health information such as information related to the provision of health care services, or that may reveal information about your health status. The Sponsor of the clinical trial is the Controller of your Personal Data, and we are the Processor, Sub-Processor, or Service Provider. Any inquiries regarding your data study participant rights should be directed to the clinical trial site or to the Sponsor of the clinical trial. Protecting your personal data and the integrity of the study are our primary concerns.

Other Partners, Service Vendors, and Authorized Third-Party Agents

When you are a business partner, service vendor, or authorized third-party agent of PCM Trials, we collect your contact and identity information such as your name, company name, title, postal address, email address and phone number and treat it as Personal Data. We collect this information to communicate with you and to manage the relationship with you as a contractor, supplier or a third-party service provider, such as for billing and payment purposes.

6. Processing Your Data

PCM Trials will Process or Use your Personal Data only if there is a legal basis for doing so. In this section, we describe the legal bases that we use for the Use of your Personal Data related to each of our main Processing activities. We will use the legal basis that is most appropriate for the purpose and circumstances related to such Processing. Below, we have explained which legal bases we may choose or have to use when Using your Personal Data.

When you provide your Personal Data directly to PCM Trials and PCM Trials determines the purposes and the means of Processing or Using your Personal Data, PCM Trials will be the Controller or Co-Controller of your data with our affiliates.

When we act or provide services on behalf of an authorized third-party (typically our Sponsor or CRO partners), PCM Trials will act as a Processor, Sub-Processor, or Service Provider.

Our Legal Bases	Examples of activities that we may conduct with your Personal Information
When we may use our legitimate business interest to Process your Personal Information	Conducting our regular commercial activities including delivering mobile site visits. Responding to requests about our products and services. Collecting information from surveys or questionnaires on our website. Complying with our legal obligations, resolving disputes with clients, enforcing our agreements. Protecting, investigating and deterring against fraudulent, harmful, unauthorized or illegal activities. Supporting recruitment inquiries. Improving our products and services.
When we rely on our contractual relationship with you to Process your Personal Information	When Using Personal Information about you, your employees or contractors, suppliers and third-party agents, for example to: Send you a request for proposal. Conduct due diligence, audits or assessments of your organization. Manage the contractual relationship with you as a contractor, supplier or a third-party service provider, such as for billing and payment purposes.
When we Process your Personal Information to comply with applicable laws	We may Use your Personal Information, including keeping or sharing it with authorities as required or when allowed by Applicable Data Protection Laws, such as to respond to government regulators, agencies, courts, or other third parties in legal proceedings.
When we may Process your Personal Information in the public interest	In limited situations and when the law of your country enables us to rely on it, we may have to Use Personal Data in furtherance of a significant public interest, such as for the prevention of diseases (e.g., in a pandemic situation) or preventing or detecting crime.
When we may Process your Personal Information for vital interests	In limited situations, PCM Trials may have to Use Personal Data about you to protect your life or against incidents or other threats (e.g., natural and man-made disasters).
When we Process your Personal Information with your consent	We may use your prior permission when the law of your country requires us to do so, for example to Use your Personal Information, disclose it, transfer it to, or share it with, third parties, including outside your country of residence. In other instances, we may require your prior consent such as to send you commercial communications electronically, such as for direct marketing, market research, surveys, or for general interactions with you.

7. Sharing Your Personal Data

PCM Trials does not sell your Personal Information and does not share your data with third parties for targeted marketing purposes.

We may disclose Personal Data to third parties in connection with their work for or with PCM Trials as described below.

Affiliates and subsidiaries. We may share Personal Data with our corporate affiliates including parent entities, subsidiaries, business units, or other companies that share common ownership.
Customers. We may share Personal Data with our customers such as clinical trial Sponsors or CROs in connection with providing our services. This sharing is limited to fulfilment of requested information, services, business inquiries, and providing customer support. We limit what we share and provide only the minimum amount of information necessary to complete/utilize the requested products, services, or to complete a transaction.
Business partners. We may share Personal Data with business partners such as clinical trial sites in connection with providing our services.
Service vendors and/or authorized third-party agents or contractors. We may outsource specific business activities to third parties. This may include companies that provide information technology services or data storage. These companies are not permitted to Use your Personal Data except for the limited purpose of providing the requested service or information.

We require such companies to comply with Applicable Data Protection Laws and work to keep your Personal Data confidential and secure. PCM Trials’ practice is to (i) perform reasonable and appropriate due diligence on our service providers; and (ii) obtain written contracts regarding the Processing of Personal Data, including that the service provider will only act in accordance with our instructions, adopt adequate technical and organizational measures, and not retain data when it is no longer required. Details concerning our service providers are available from PCM Trials by contacting its Data Protection Officer at [email protected].

Entities in connection with a corporate transaction. If we sell or transfer a business unit or an asset (such as a website) to another company, we may transfer the Personal Data collected to the relevant third party.
Law enforcement, government agencies, and other recipients for legal, security, or safety purposes. As required by law, we may respond to subpoenas, court orders, or similar legal process by disclosing your Personal Data and other related information, if necessary. We also may use Personal Data and other related information to establish or exercise our legal rights or defend against legal claims. We may collect and possibly share Personal Data and any other additional information available to us in order to investigate, prevent, or take action regarding illegal activities, suspected fraud, situations involving potential threats to the physical safety of any person, violations of PCM Trials’ terms of service, or as otherwise required by law.

Further, our websites and services may provide links to other third-party websites and services which are outside our control and not covered by this Privacy Statement. We encourage you to review the privacy policies/statements/notices posted on these (and all) sites you visit or services you use.

8. Securing Your Personal Data

PCM Trials is committed to protecting the Personal Data you share with us. We utilize a combination of industry-standard security technologies, procedures, and organizational measures to help protect your Personal Data from unauthorized access, use or disclosure.

Data in Transit: When we transfer Personal Data over the Internet, we protect it using multiple encryption methods as required by system protocols.
Data at Rest: Where appropriate, we use encryption, pseudonymization (such as key coding), de-identification and other technologies that can assist us in securing the information about you, including measures to restore access to your information.
Service Providers: We require our service providers to comply with reasonable and recognized data privacy and security requirements.

We recommend you take every precaution in protecting your Personal Data when you are on the Internet: change your passwords often, use a combination of letters and numbers when creating passwords, and make sure you use a secure browser. If you have any questions about the security of your Personal Data , you can contact us at [email protected] or by using the contact details below in the “Contact Us” section of this Privacy Statement.

9. Transfer and Storage of Personal Data

As a multinational company, PCM Trials may transfer or share your Personal Data with parties located outside of your country of residence. If you are located outside of the United States, PCM Trials may share your Personal Data with parties located in countries that provide less protection than in your country, which includes the United States. We may also Process and share your Personal Data with some of our affiliates and approved third parties (vendors and business partners) that help us operate internationally. When transferring Personal Data across country borders, PCM Trials utilizes appropriate transfer mechanisms as applicable (which may include consent, Standard Contractual Clauses, existing adequacy decisions, etc.). Nevertheless, all PCM Companies are required to treat Personal Data in a manner consistent with this Privacy Statement and our internal global privacy policies.

By using our services or providing Personal Data for any of the purposes stated above, you consent to the collection, storage, and processing of your information in the United States and in any country to which we may transfer your information in the course of our business operations, whether provided by you or obtained through a third party, including the hosting of such Personal Data on servers in the United States.

10. Data Retention

PCM Trials stores your Personal Data no longer than necessary. How long we retain your data depends on the type of data and the purpose for which the data was collected and processed. We will typically keep your information for no longer than the purpose(s) for which it was obtained, unless we have a legal obligation to keep it for a longer period or retention is advisable for PCM Trials’ legal position (for example, regarding applicable statutes of limitations, litigation or regulatory investigations).

Clinical trial data collected on behalf of our Sponsors’ Trial Master File will be stored for a minimum of seven years or in accordance with our contractual agreements.

11. Cookies and Automated Tracking Technologies

As you navigate through and interact with our website, we or our service providers may use automated data collection technologies to collect certain information about your equipment, browsing actions, and patterns, including:

Details of your visits to our website, including traffic data, location data, logs, and other communication data and the resources that you access and use on the website.
Information about your computer and internet connection, including your IP address, operating system, and browser type.

The information we collect automatically does not include Personal Data. It helps us to improve our website and to deliver a better and more personalized service, including by enabling us to:

Estimate our audience size and usage patterns.
Store information about your preferences, allowing us to customize our website according to your individual interests.
Speed up your searches.
Recognize you when you return to our website.

The technologies we use for this automatic data collection may include:

Cookies (or browser cookies). Cookies are small data files placed on your device when you visit a website. They enable the website to remember your actions, preferences, and other information related to your visit (IP address, time of visit, number of visits, login data, preferred language, time spent on the website, etc.), for a certain period of time. PCM Trials and our partners use cookies or similar technologies to analyze trends, administer the website, track users’ movements around the website, and gather demographic information about our user base. For information regarding the cookies or similar technologies that PCM Trials uses and how to change your preferences, please review our Cookie Statement.
Web Beacons. Pages of our website may contain small electronic files known as web beacons (also referred to as clear gifs, pixel tags, and single-pixel gifs) that permit PCM Trials, for example, to count users who have visited those pages or and for other related website statistics (for example, recording the popularity of certain website content and verifying system and server integrity).

12. Children’s Online Privacy Information

Our website is not intended for minors under the age of 18. No one under the age of 18 may provide any Personal Data to or on our website. If you are under the age of 18, do not use or provide information on the website. If we learn we have collected or received Personal Data from a minor under the age of 18 without verification of parental consent, we will delete that information. PCM Trials does not knowingly collect Personal Data from any person under the age of 18 unless a parent or guardian provides consent.

Under certain circumstances, PCM Trials may receive the Personal Information of minors under the age of 18 who are participating in a clinical trial. In those instances, a rigorous protocol of parental consent is managed by the clinical trial site, and questions regarding Personal Information should be directed to that entity or directly to the Sponsor.

If you believe that we have inadvertently or unintentionally collected the Personal Information of a minor under the age of 18, please notify us at [email protected] so that we may delete the information from our servers.

13. Your Rights and How to Exercise Them

If you have previously consented, requested, or had a relationship with PCM Trials, you may receive marketing materials, including emails, from PCM Trials or our affiliates. You may opt-out of those marketing messages at any time by unsubscribing through the “unsubscribe” or “opt-out link” in an email or via the following opt-out form: PCM TRIALS Unsubscribe.

Please note that if you opt out of receiving our marketing-related emails, PCM Trials may still need to send transactional emails regarding important service communications because of our relationship or contract with you.

Residents of certain regions, including the European Economic Area, the United Kingdom, Switzerland, California and certain other states in the United States, have certain rights with respect to their personal information as set forth below. These rights are not absolute and only apply in certain circumstances. This means we may be unable (e.g., due to legal requirements) or not obligated, to satisfy your request. Please note that in some circumstances we may ask for additional personal information in connection with your request if, for example, we need to verify your identity or the nature of your request. PCM Trials will make every effort to respond in a reasonable timeframe with a determination of our responsibilities or seeking verification of the request, as per Applicable Data Protection Laws.

Your Rights:

Access: You can request more information about the Personal Information we hold about you. You can also request a copy of your Personal Information.
- FOR CALIFORNIA RESIDENTS: You have the right to ask us to disclose to you any Personal Information we have collected about you in the last 12 months including the categories of Personal information we have collected about you; the types and sources used to collect Personal Information about you; the types of third parties with which we have shared any of your Personal Information (if applicable); and the purpose(s) of collecting your Personal Information.
Correction: If you believe the Personal Information we are holding about you is incorrect or incomplete, you can request that we correct or supplement such data.
Objection/Opt-Out: You can contact us to let us know that you object to the collection or use of your Personal Information for certain purposes. You can choose not to disclose your information. However, if you elect to skip such disclosures, our ability to respond to inquiries or provide services will be limited to the information you chose to share.
Erasure/Deletion: You can request the deletion of some or all of your Personal Information from our systems.
Restriction of Processing: You can ask to restrict further Processing of your Personal Information.
Portability/Transfer: You can ask for a copy of your Personal Information in a machine-readable format. You can also request that we transmit the data to another entity where feasible.
Withdrawal of Consent: If we are Processing your Personal Information based on your consent, you have the right to withdraw your consent at any time.
Right to File a Complaint: You have the right to lodge a complaint about PCM Trials’ practices with respect to your Personal Information with the supervisory authority of your country or E.U. Member State, or with the California Attorney General’s Office.
ADDITIONAL INFORMATION FOR CALIFORNIA RESIDENTS:
- Authorized Agents: You have the right to designate an authorized agent to act on your behalf to exercise your rights. In order to do so, PCM Trials must verify your identity, and your authorized agent must have written permission from you. We reserve the right to deny a request from an agent that does not submit proof that they are authorized to act on your behalf.
- Non-Discrimination: You have the right to be free from unlawful discrimination for exercising your privacy rights under the law.
- Consumers with Disabilities: PCM Trials strives to accommodate all individuals regardless of disabilities. If you need this information contained in this document in a different format, please contact us using the contact information below.
- DO NOT SELL: PCM Trials does not “sell” your Personal Information. For purposes of this disclosure, “sell” means the disclosure of Personal Information for monetary or other valuable consideration.

To make any of the above requests pursuant to your rights under Applicable Data Protection Laws, please contact our Data Privacy Officer at [email protected] or by using the contact details below in the “Contact Us” section of this Privacy Statement. We will do our best to comply with your request(s) as soon as reasonably practicable.

If you are a clinical trial participant, please direct your inquiry to the clinical trial site that is managing your clinical trial.

14. Contact Us

Any questions or comments related to this Privacy Statement can be emailed to [email protected] or by phone at 888-886-2281.

You may also contact us by writing to this address:

PCM Trials
Attention: Privacy – PCM Data Protection Officer
500 E. 8th Avenue
Denver, CO 80203

For any other questions regarding our services or sister companies, please email [email protected] or write to the following address:

PCM Trials
Attention: Outreach Help Center
500 E. 8th Avenue
Denver, CO 80203

15. EU Representative

We have appointed The DPO Centre Europe Ltd as our EU representative. Their contact details are as follows:

The DPO Centre Europe Ltd
Alexandra House
3 Ballsbridge Park
Dublin, D04C 7H2
Ireland

Email: [email protected]
Tel: +353 1 631 9460

16. Changes to this Privacy Statement

We may make changes to this Statement from time to time based on changes to applicable laws and regulations or other requirements applicable to us, changes in technology, or changes to our business.
Any changes made in the future will be posted on this page.

Updated: 4/2024