Updated January 1, 2020.
Our Approach to Privacy
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, Optimal Research, LLC ( “Optimal,” “we,” “us,” and “our”) 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.
If you are a resident of the State of California, this Policy also incorporates our Privacy Notice for California Residents, which includes additional information required to be provided under California law.
Optimal has enacted internal policies, procedures and training programs designed to support compliance with these laws and this Policy. Our policies, procedures and training programs are reviewed on a regular basis, and overseen by a team of privacy professionals with senior executive oversight.
What Types of Personal Information Does Optimal Handle and for What Purposes?
Clinical and Medical Information
As a site management organization, Optimal provides investigational sites for clinical trials conducted by our clients. As such, we collect, host and analyze significant quantities of health data and bio-medical samples relating to study subjects on our clients’ behalf.
To enhance privacy, consistent with ICH Good Clinical Practice (“GCP”), study subjects’ names and other direct identifiers are not attached to records or samples utilized by Optimal’s clients for research purposes.
Clinical Trial Volunteer Information
We also collect and maintain the personal information of individuals who have expressed interest in participating in clinical trials in our volunteer database. This information may include these individuals’ names, telephone numbers, email addresses, states and cities of residence, dates of birth, and health conditions in which they are interested. We use this information to recruit individuals for clinical trials and to run general statistical analysis in support of patient recruitment.
We also collect and maintain the names and contact information of individuals who refer their family and friends to participate in our clinical trials through our Study Buddy program. We use this information to administer the Study Buddy program and to provide compensation to those individuals for successful referrals.
Industry Professional Information
In the course of conducting our business, Optimal will interact with employees, consultants, contractors and other third parties employed or engaged by our clients involved in clinical and medical research. Optimal will record and use 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 Optimal’s services to our clients.
Employee and Human Resource Data
Optimal collects personal information from applicants seeking employment with the company, including private contact details, professional qualifications and previous employment history to inform employment decisions. Optimal conducts various background checks on applicants, including where law allows on criminal history and professional disbarment. Once employed, Optimal collects information on staff for human resource, performance, payroll and tax purposes. Optimal will collect and record employee level information in various company systems, consistent with standard business operations. Optimal processes similar information relating to consultants, contractors and other third parties engaged by the company to provide products or services to it.
Optimal collects named information about visitors to Optimal 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.
Through the use of cookie-based technologies, Optimal 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 Optimal 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 will be shared within Optimal and its affiliated companies and with third parties, including our agents and service providers, 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. Optimal does not trade or sell personal information.
Under some circumstances, Optimal may be required by law enforcement or judicial authorities to disclose certain personal information as part of investigations or for litigation purposes. Optimal 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 Optimal or some or all of its assets.
Companies working as vendors of Optimal are required to sign “processor” and/or confidentiality agreements whereby they will commit to only process personal information consistent with contracted purposes and apply appropriate organizational and technical security safeguards.
International Transfers of Personal Information
Optimal may share personal information across international borders as required to service global projects. Optimal hosts personal information in databases in the United States. In certain circumstances, Optimal and client personal information will be hosted within vendor platforms located in the Internet cloud. Optimal recognizes that many countries globally have regulations restricting the flow of personal information across international borders. Optimal 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, Optimal will provide notice 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, Optimal 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 also where it is a matter of good practice, Optimal will seek 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 will involve a disproportionate effort, where intended processing of the data is in Optimal’s or our clients’ legitimate interests and the privacy risks are low, Optimal will proceed to process personal information absent of consent. Also, Optimal will use and disclose personal information without consent where required by law and judicial order. Consistent with GCP, laws on confidentiality and data privacy regulations, Optimal will collect 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 Optimal. 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, Optimal employs a professional quality assurance department. In general, our privacy notices provide individuals easy means of validating, correcting errors and updating information. Optimal retains personal information in accordance with contractual, legal and regulatory requirements.
In jurisdictions with data privacy laws, and where contractual commitments require, Optimal 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 the themselves or another organization.
In all other respects, where no overriding interest prevails, Optimal will endeavor to allow the following informational rights under this Policy as a matter of good practice:
Subjects enrolled in clinical studies run by Optimal’s clients must contact the investigator at their Optimal site, who will be able to make the necessary link to subject identity.
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, particularly under U.S. state law and the Regulation, Optimal also maintains a detailed Security Breach Policy, which establishes a procedural response to dealing with any breach of personal information, including making any necessary notifications to individuals or governmental authorities.
Your online relationship with Optimal may be managed by using settings available on most internet browsers. At this time, we do not respond to “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 Optimal websites.
Children’s Online Privacy Protection
Optimal 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, requests to exercise informational rights (e.g., access to data) or complaints can be sent by email to firstname.lastname@example.org.
Legal Status of Policy and Policy Changes
This Policy is not a contract, and it does not create any legal rights or obligations. Optimal reserves the right to modify or amend this Policy. For instance, the Policy may need to change as new legislation is introduced or as it is amended. The updated Policy will be posted on https://www.optimalsites.net/privacy-policy
15201 Shady Grove Road
Rockville, MD 20850