About Aptiv Solutions
Aptiv Solutions is a global development services company focused on enhancing clinical trial decision-making, efficiency and productivity for pharmaceutical, biotech and medical device sponsors. It is the only contract research organization (CRO) to offer design, simulation and execution of adaptive clinical trials along with an extensive portfolio of innovative services. These services span the entire product development cycle from first in human through regulatory approval to post-marketing. Aptiv Solutions has more than 850 professionals in North America, Eastern and Western Europe, Israel and Japan.
Aptiv Solutions respects the privacy of our employees, customers, business partners, health care providers, medical research subjects and our investors who have entrusted us with their personal data. As a manifestation of this respect, Aptiv Solutions complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information from European Union member countries and Switzerland. In addition, Aptiv Solutions is committed to follow the EU Data Protection Directive, Canada’s Personnel Information Protections and Electronic Document Act (PIPEDA) the U.S. Health Insurance Protection and Accountability Act (HIPAA) and Japan’s Personal Information Protection Act (PIPA). Aptiv Solutions has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement as well as dispute resolution.
To learn more about the SafeHarbor program, and to view the Aptiv Solutions certification, please visit http://safeharbor.export.gov/list.aspx
This Policy includes protection of all Personal Information associated with clinical research studies, or information submitted on our website for the purpose of obtaining information about the services that Aptiv Solutions provides. This information is collected either in electronic or paper format, and received by Aptiv Solutions in the United States from the EU or Switzerland. This Personal Information can be related to employees or potential employees, customers or potential customers, investigators, clinical trial subjects, sponsors/clients and suppliers, in the U.S., EU and Switzerland.
The privacy principles stated below are based on the U.S.-and U.S. Swiss Safe Harbor Privacy Principles
When Personal Information is collected from individuals in the U.S., EU and Switzerland who participate as clinical trial subjects, investigators, and investigators’ staff involved in clinical trials managed by Aptiv Solutions, or by customers or potential customers requesting information on the services provided by Aptiv Solutions, they will be informed of the following:
- The purpose for which the information is collected and used, and which safeguards are implemented to limit the use and disclosure of their information
- That Personal Information may be transferred to study sponsors, business partners, and third party service providers
- When Aptiv Solutions will provide their personal data of third parties for purposes not originally intended.
- That their data will not be kept for longer than is necessary for the purpose or purposes originally stated
- That Aptiv Solutions will process information in support of our Human Resource function to administer benefits, compensation, performance and disciplinary procedures
THE INFORMATION WE COLLECT
This notice applies to all information collected or submitted on the Aptiv Solutions website. We collect information in several ways, which are described below:
1. You can register to receive information on an automated, “alert” basis. The type of information that you can register to receive on an automated basis includes general information about Aptiv Solutions such as:
- Press releases
- News and blog alerts
The personal information collected when you register to receive automated information is typically your name and email address. Each time you receive an automated email alert, you have the option of canceling your registration and removing your email from the database by simply clicking on the unsubscribe link at the bottom of each email alert message.
2. You may opt to provide us information about yourself if you are interested (a) in serving as an investigator in a clinical trial; or (b) in pursuing an employment opportunity at Aptiv Solutions. The information requested from you will be based on your area of interest.
3. You can register to receive customized information. This information is generally collected on “Contact Us” forms where you can ask an Aptiv Solutions representative to contact you in order to answer questions or provide specific information. The personal information you provide on these forms may include your name, title, company name, address, contact numbers, and email.
4. You can choose to register to receive access to webcasts, periodic newsletters, or information on a specific Aptiv Solutions product or service. Generally, the personal information collected when you register to receive this type of information is your name, company, affiliation, address, and email address. This information is collected for qualification and aggregate measurement purposes only.
5. You may choose to enter personal information about yourself that may allow you access to specific Aptiv Solutions information or services. For example, clients may enter identifying information that allows them to access their project information.
THE WAY WE USE INFORMATION
We store the information you provide about yourself in a secure database in order to provide you with the information, products, and/or services you request. The information is stored for the lifetime of the database unless you request that it be removed. You must consent for us to share your identifiable information with third parties, who would be bound by a confidentiality agreement. The information you provide us about yourself will be shared with Aptiv Solutions employees, consultants or contractors to the extent necessary to accommodate your request. You can also update your information at any time.
For example, if you provide your name, mailing address, telephone and email address and request more information about services provided by Aptiv Solutions this information will be shared with the appropriate personnel at Aptiv Solutions or consultants to fulfill your request. This information will not be shared with any other outside third parties. Again, you can change your preferences on the registration page at any time.
We use non-identifying and aggregate information about the use of our website to improve the navigation, content, and design of our site. This information may include, for example, the most and least requested pages and the number of users from the U.S. and other countries, among other things.
Finally, unless otherwise excepted below, we would not use your personally identifiable information provided to us online for purposes other than those you requested without also providing you an opportunity to agree or otherwise limit such unrelated purposes.
Except as described above, we will not otherwise use or disclose any of your personally identifiable information, except to the extent reasonably necessary: (i) to correct technical problems and malfunctions and when we process your information; (ii) to protect the security and integrity of our website; (iii) to protect our rights and property and the rights and property of others; (iv) to take precautions against liability; (v) to comply with laws or to respond to judicial process; or (vii) to provide information to law enforcement agencies or for an investigation on a matter as applicable or otherwise required or permitted by law.
Any individual who provides Personal Information to Aptiv Solutions is given the opportunity to choose (opt-out) whether their Personal Information will be disclosed to a third party or used for a purpose incompatible with the purpose for which it was originally collected or subsequently authorized by the individual, unless requested by law. For sensitive information, an individual will be given the explicit (opt-in) choice for that information to be disclosed to a third party or used for a purpose other than that for which it was originally collected or subsequently authorized by the individual through the exercise of the opt-in choice. The Personal Information collected must be adequate, relevant and not excessive in relation to the purpose or purposes for which they are processed. In replying to individual inquiries about Aptiv Solutions services, we will use the Personal Information provided to process the requested information.
ONWARD TRANSFER (Transfers to Third Parties)
Authorized agents or third parties working on behalf of Aptiv Solutions and its clinical trial sponsors are required to properly execute confidentiality agreements in connection with handling confidential information containing Personal Information in accordance with applicable laws ante these Safe Harbor Principles. Where Aptiv Solutions exchanges Personal Information with a third party (e.g., sponsors, client, supplier, or partner service provider) the third party has to comply with these principles and must provide evidence of a similar data exchange agreement with commitment to Safe Harbor agreement and the current EU Directive on Data Protection. When Aptiv Solutions becomes aware that an agent or third party or partner is using or disclosing Personal Information contrary to this policy, Aptiv Solutions will take reasonable steps to prevent or stop the use or disclosure. Aptiv Solutions will not transfer Personal Information outside the European Economic Area unless the country in question ensures an adequate level of protection for the rights and freedoms of clinical trial subjects in relation to the processing of Personal Information.
On request, and as required by law, Aptiv Solutions and/or an involved third party provider will take reasonable steps to permit individuals to correct, amend, or delete information that is demonstrated to be inaccurate or incomplete except where the burden or expense of providing access would be disproportionate to the risk to the individual’s privacy, or where the rights of individuals other than the requestor would be violated. Aptiv Solutions when acting as a CRO and has no direct relationship with the Personal Information in question, will direct the inquirer to the study sponsor or the investigator who has transferred the Personal Information to Aptiv Solutions for processing. Aptiv Solutions will process Personal Information fairly and lawfully and will only process Personal Information if certain conditions are met.
Aptiv Solutions and/or an involved third party provider will apply reasonable technical, administrative and physical safeguards to protect personal information in its possession from loss, misuse, unauthorized access, disclosure, alteration, and/or destruction. Internal audits are conducted to ensure that security is maintained. All Personal Information of clinical trial subjects are protected by means of anonymization or pseudonymization. In addition, Aptiv Solutions does not directly contact any subjects. All interaction is only through the relevant investigator. To minimize the risk of unauthorized disclosure of clinical study related Personal Information, these data are maintained within the study data structure with controlled access. When any employee of Aptiv Solutions or of a third party becomes aware of a data security breach, they are required to notify their respective supervisor and the Privacy Officer who will implement corrective action and preventive action.
Aptiv Solutions will use Personal Information that it collects solely for the purposes expressed at the time of collection unless the individual authorizes otherwise. Aptiv Solutions will take reasonable steps to ensure that Personal Information is relevant to its intended use, and is accurate complete and current. Aptiv Solutions collects and processes Personal Information for only specified and lawful purposes and does not process the information in any manner incompatible with that purpose or purposes.
Any questions or issues related to the use or disclosure of Personal Information should be directed to the Aptiv Solutions Privacy Officer at: Data.Privacy@aptivsolutions.com. The EU Data Protection Authorities and the Swiss Federal Data Protection and Information Commissioner will provide the independent recourse mechanism to resolve all disputes related to Personal Information collection, processing and use for EU countries and Switzerland, as well as to provide an independent mechanism to investigate unresolved complaints related to the commitment to Safe Harbor Principles.
This policy may be reviewed and changed from time to time without notice consistent with the requirements of the U.S.-EU and U.S.-Swiss Safe Harbor Privacy Principles. All changes will be posted on the Aptiv Solutions website; http://www.aptivsolutions.com