PCM Trials Privacy Statement

6. Processing Your Data

PCM Trials will Process your Personal Data only if there is a legal basis for doing so. In this section, we describe the legal bases for the Use of your Personal Data related to each of our main Processing activities. We list below the legal basis that is most appropriate for the purposes and circumstances related to such Processing.

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 (such as our Sponsor or CRO partners), PCM Trials will act as a Processor, Sub-Processor, or Service Provider with respect to your Personal Data.

7. Sharing Your Personal Data

PCM Trials does not sell your Personal Data to third parties for 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 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 and legally approved 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.

In addition, the PCM Trials U.S.-based entities, including Act for Health, Inc. and Professional Case Management Clinical Trials, LLC, comply with the EU-U.S. Data Privacy Framework (EU-U.S. DPF), the UK Extension to the EU-U.S. Data Privacy Framework, and the Swiss-U.S. Data Privacy Framework (Swiss-U.S. DPF) as set forth by the U.S. Department of Commerce and study participant to the regulatory enforcement powers of the U.S. Federal Trade Commission.  PCM Trials has certified to the U.S. Department of Commerce that it adheres to the EU-U.S. Data Privacy Framework Principles with regard to the processing of Personal Data received from the European Union (and Iceland, Liechtenstein, and Norway) in reliance on the EU-U.S. DPF) and from the United Kingdom (and Gibraltar) in reliance on the UK Extension to the EU-U.S. DPF.  PCM Trials has certified to the U.S. Department of Commerce that it adheres to the Swiss-U.S. Data Privacy Framework Principles with regard to the processing of Personal Data received from Switzerland in reliance on the Swiss-U.S. DPF.  If there is any conflict between the terms in this privacy statement and the EU-U.S. Data Privacy Framework Principles and/ or the Swiss-U.S. Data Privacy Framework Principles, the Principles shall govern.  To learn more about the Data Privacy Framework (DPF) program, and view our certification, please visit https://www.dataprivacyframework.gov/.

PCM Trials is responsible for the processing of Personal Data it receives or subsequently transfers to a third party acting as an agent on its behalf. PCM Trials complies with applicable data protection law, including the onward transfer liability provisions in the Data Privacy Framework Principles for all onward transfers of Personal Data from the EEA, UK, and Switzerland.

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 legally 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 keep your information to fulfill the purpose(s) for which it was obtained, unless we have a legal reason or obligation to keep it for a longer period.

Clinical trial participant 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 activity 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 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.
• Analyze trends on the usage of our website.
• 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).

We comply with Applicable Data Protection Laws in the collection and use of cookies and automated tracking technologies on our website, including through our cookie banner and management tool.

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.

In compliance with our self-certification under the EU-U.S. Data Privacy Framework, the UK-U.S. Data Privacy Framework, and the Swiss-U.S. Data Privacy Framework, PCM Trials commits to resolve complaints about your privacy and our collection or use of your Personal Data transferred to the United States pursuant to the Data Privacy Framework (DPF) Principles.

For any DPF inquiries or complaints, please contact our Data Privacy Officer using the contact details below.  PCM Trials has further committed to refer unresolved privacy complaints under the DPF Principles to an independent dispute resolution mechanism, JAMS.  If you do not receive timely acknowledgement of your complaint, or if your complaint is not satisfactorily addressed, please visit https://www.jamsadr.com/DPF-Dispute-Resolution for more information and/or to file a complaint.  This service is provided free of charge to you.

If your DPF complaint cannot be resolved through the above channels, under certain conditions, you may invoke binding arbitration for some residual claims not resolved by other redress mechanisms.  See Data Privacy Framework Program for more information.

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

You have a right to lodge a complaint with a supervisory authority, you can find the relevant supervisory authority name and contact details for the EEA here, the UK here, and Switzerland here.

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.