Personal Data Privacy Notice

Clinical and medical research are founded upon the collection and analysis of the most confidential information about people.

Individuals will only share their sensitive information where there is a culture of trust and where stakeholders implement safe data handling practices. Operating within this environment, Clinergy Health Research (together “CLINERGY,” “we,” “our,” or “us”) recognize that when we handle information about any individual, we must do so responsibly, with due care to individual privacy, complying with laws on data privacy and confidentiality.

CLINERGY has enacted internal policies, procedures and training programs designed to support compliance with personal data privacy requirements. Our policies, procedures and training programs are reviewed on a regular basis and are managed by a team of privacy professionals with senior executive oversight.

What Types of Personal Information Does CLINERGY Handle and for What Purposes?

Clinical and Medical Information

As a Collaborative Research Organization, we collect, host and analyze health data relating to study subjects on behalf of our clients. To enhance privacy, consistent with GCP, subjects’ names and other direct identifiers are not attached to records or samples collected by CLINERGY for research purposes. Instead, subjects are only identified by a code. Only study doctors and authorized personnel, including CLINERGY monitors and CLINERGY auditors, may access named subject records at source. In cases where local law allows, CLINERGY may also collect full date of birth attached to study records. We maintain that this indirect identifier can on occasion serve to verify subject identity to the benefit of patient safety.

CLINERGY provides additional services that may involve the collection of health information linked to named individuals, for example in our Phase I Clinics, and within operations supporting patient recruitment, patient concierge, observational research, and medical information. We appreciate the sensitivity of such information, and the privacy protections we apply in these areas are more rigorous.

All clinical and medical information processed by CLINERGY is done so under contract with our clients. In terms established by the Regulation, CLINERGY considers that the sponsor/client is ultimately in control of how and why clinical and medical data are processed within our services and as such is the “controller,” whilst CLINERGY and its affiliates are “processors.”

Health Professional Information

CLINERGY collects the names, contact details, and professional information of doctors and other health care providers for the purpose of identifying potential investigators to assist in clinical and medical research on specific indications. The company will use this information for the purpose of inviting potential investigators to apply to participate in research. CLINERGY will source health professional information directly from those professionals, such as when they create an online investigator profile or apply to participate in research, and from public sources, data brokers and referrals. For operational purposes, CLINERGY will also collect information relating to the involvement and performance of investigators and supporting study staff. The company will also process financial information of investigators to support payment for services.

Industry Professional Information

In the course of conducting our business, CLINERGY interacts with employees, consultants, contractors and other third parties employed or engaged by our clients involved in clinical and medical research. CLINERGY records and uses the names, contact details and other professional information on these individuals for legitimate business-related purposes, including project and financial administration. We may use the information we obtain, including email addresses, to provide relevant information on CLINERGY’s services to our clients.

Employee and Human Resource Data

CLINERGY collects personal information from applicants seeking employment with the company, including private contact details, professional qualifications and previous employment history to inform employment decisions. CLINERGY conducts various background checks on applicants, including where law allows on criminal history and professional disbarment. Once employed, CLINERGY collects information on staff for human resource, performance, payroll and tax purposes. CLINERGY collects and records employee level information in various company systems, consistent with standard business operations. CLINERGY processes similar information relating to consultants, contractors and other third parties engaged by the company to provide products or services to it.

Web Visitors

CLINERGY collects named information about visitors to company websites where this is voluntarily provided to meet a request from those individuals, for example where a client contact requests information on a company service, a health professional is interested in participating in a clinical trial or where someone wants to apply for a vacant position with the company. Using cookie-based technologies, CLINERGY may collect various data linked to virtual identities allocated to visitors when they access our websites. This data is used for various purposes, including site analytics and first party marketing (see Online Issues below). In certain cases, these virtual identities are linked to the real-world identities of visitors when they provide their named information as described above. This allows CLINERGY to tailor marketing messages to those individuals, inclusive of information that is likely to be of interest to them.

Internal and External Disclosures of Personal Information

Personal information are shared within CLINERGY, with companies working as agents of CLINERGY and with other third parties only on a “need to know” basis to meet stated legitimate business purposes. Access to databases and folders containing personal information is restricted to appropriate staff. CLINERGY does not trade or sell personal information.

Under some circumstances, CLINERGY may be required by law enforcement or judicial authorities to disclose certain personal information as part of investigations or for litigation purposes. CLINERGY may disclose personal information to a buyer or other successor in the event of a merger, divestiture, restructuring, reorganization, dissolution or other sale or transfer of CLINERGY or some or all its assets.

Companies working as vendors of CLINERGY are required to sign “processor” and/or confidentiality agreements whereby they commit to only process personal information consistent with contracted purposes and apply appropriate organizational and technical security safeguards.

International Transfers of Personal Information

CLINERGY is a global company serving an industry that is increasingly globalized in its approach to clinical research. Personal information are shared across international borders as required to service global projects. CLINERGY hosts personal information in databases in different locations throughout the world, mainly in the United States. In certain circumstances, CLINERGY and client personal information will be hosted within vendor platforms located in the Internet cloud. CLINERGY recognizes that many countries globally have regulations restricting the flow of personal information across international borders. CLINERGY has put in place measures to ensure that adequate protection is provided to such data where legally mandated.

Notice and Consent

At the point of data collection, CLINERGY provide notices to individuals in a clear and conspicuous language about how their information will be used, disclosed and transferred; what choices they have in relation to how their data are handled; what informational rights they have under data privacy law or under this Policy; and who to contact with any questions or complaints. These privacy notices are tailored to specific situations of data collection. In providing such notice, CLINERGY meets its obligations to be transparent and fair with individuals as is required by many data privacy laws. Dependent on the medium, notice may be given in person, by email, post, telephone, or by posting on our website.

In many situations, including where mandated by data privacy law, and where it is a matter of good practice, CLINERGY seeks consent of individuals to collect, use and disclose their data consistent with the relevant privacy notice. However, in certain cases where law allows, particularly where gaining consent involves a disproportionate effort, where intended processing of the data is in CLINERGY’s or our clients’ legitimate interests and the privacy risks are low, CLINERGY may proceed to process personal information absent of consent. Also, CLINERGY uses and discloses personal information without consent where required by law and judicial order. Consistent with GCP, laws on confidentiality and data privacy regulations, CLINERGY collects necessary informed consents of study subjects on behalf of its clients.

Data Quality and Record Retention

Data quality and accuracy are fundamentally important principles to CLINERGY. Crucial to the integrity of clinical research is the accuracy of data relating to study subjects, particularly where attached to bio-medical samples. Consistent with regulatory requirements, CLINERGY employs a professional quality assurance department. In general, our privacy notices provide individuals easy means of validating, correcting errors and updating information. CLINERGY retains personal information in accordance with contractual, legal and regulatory requirements.

Informational Rights

In jurisdictions with data privacy laws, and where contractual commitments require, CLINERGY ensures that individuals can exercise all relevant informational rights with respect to their personal information processed by the company, including but not limited to the right of access and correction, to withdraw consent at any time, object to data processing, request data deletion, restrict aspects of data processing, prevent direct marketing and request transmission of personal data in a common digital format (e.g., pdf) to themselves or another organization.

In all other respects, where no overriding interest prevails, CLINERGY will endeavor to allow the following informational rights under this Policy as a matter of good practice:

·       to allow access to copies of personal information within a reasonable timeframe;

·       to correct personal information where inaccurate;

·       – to allow study investigators to opt out of future solicitations to participate in studies, by contacting and

·       to withdraw a previously provided consent to processing of personal information.

Information Security

The company maintains a comprehensive information security policy that seeks to apply technical and organizational security measures that protect personal information, particularly sensitive clinical data, against unauthorized access or loss. Consistent with regulatory requirements, CLINERGY also maintains Security Breach Procedure, which establishes a procedural response to dealing with any breach of personal information, including making any necessary notifications to individuals or governmental authorities.

Online Issues

CLINERGY Web pages may contain links to websites outside of the company. Linked websites are not under the control of or endorsed by CLINERGY. This Policy does not apply to linked websites outside the CLINERGY organization. It is recommended that visitors review the privacy policy of each individually linked website.

Our websites also use cookies. A cookie is a data file that is placed by a website operator on the hard drive of a visitor to their site. CLINERGY and third parties with whom we work may place cookies with the following functions on the computers of visitors to CLINERGY websites: to allow the site to deliver the service requested by the visitor; to remember repeat visitors; to improve the user experience of the site; to allow the company to perform site analytics; and to serve and help tailor CLINERGY’s marketing messages on our websites and elsewhere on the internet based the visitor’s previous browsing activity.

Your online relationship with CLINERGY may be managed by using settings available on most internet browsers. At this time, we do not respond to browser “do not track” signals, however most browsers will allow a visitor to choose which cookies can be placed on his/her computer, and to delete or disable cookies. Please note that disabling cookies may prevent a visitor from using certain features on CLINERGY websites. When required by applicable law, CLINERGY will seek your consent for the placement of certain types of cookies.

Children’s Online Privacy Protection

CLINERGY does not collect information through our websites from individuals who are known to be under the age of 13, and no part of our online presence is directed to anyone less than 13 years.

Inquiries, Complaints and Requests to Exercise Rights

Communications, queries or requests to exercise informational rights (e.g., access to data) or complaints can be addressed to the attention of the Data Protection Officer via the email info@clinergyhealth.com