Boston Biomedical Associates (BBA) is a full service clinical research organization. Our mission is to define and provide our clients with the most integrated strategic plan possible to propel their products forward to market in an effective and timely manner. For over 15 years, BBA has helped sponsors with global drug and device clinical research.
- Known for its therapeutic excellence, BBA has extensive experience across numerous indications;
- BBA’s senior regulatory team members have extensive experience communicating with all branches within the FDA, including the office of the FDA Ombudsmen, Notified Bodies and other regulatory agencies;
- BBA has the global expertise and local understanding of laws and culture to proactively plan and execute trials of all sizes in any location.
BBA uses web-based access for study data through various electronic databases managed and maintained by our service providers. BBA’s uncompromising commitment to research and to the highest level of ethical standards and performance supports our compliance with laws around the globe relating to data protection and privacy.
BBA is committed to respecting the privacy of individuals. This Privacy Statement applies to all personal data including that collected on our website, personal data that may be provided for clinical trials, and personal data collected from employees and job applicants.
CLINICAL TRIAL SUBJECTS: BBA collects medical and health information about the individuals that take part in the clinical trials through physician investigators. The physician investigators, who examine the individuals before and during the clinical trials, make sure that the individuals understand and consent to the gathering of sensitive personal data relating to an individual’s health and lifestyle, and the transfer of such information to third parties. BBA complies with the requirements of the US Health Insurance Portability and Accountability Act (HIPAA), the European Union Data Protection Directive (EUDP), Canada’s Personal Information and Electronic Documents Act (PIPEDA), Japan’s Personal Information Protection Act (PIPA), and regulations of other countries with data protection laws. Such laws generally require that consent must be obtained before any health or sensitive data is collected from individuals.
INVESTIGATOR PHYSICIANS: BBA collects personal data about the investigator physicians that take part in a clinical study. This allows BBA to quickly identify and contact physicians for participation in other clinical studies. BBA complies with all worldwide data protection laws that require physician investigators to receive notice about the collection of their personal data and the right to access, modify or delete their personal data.
EMPLOYEES: On our website and through our offices, BBA may collect information from job applicants and employees. BBA complies with data protection and privacy laws that require individuals to receive notice of the collection of their personal data and the right to access, modify or delete their personal data in accordance with the law.
INTERNATIONAL TRANSFER OF DATA: The personal information we collect from individuals who take part in clinical trials, the physician investigators, and job applicants and employees, may be shared among BBA affiliates and with other third parties. BBA has enacted internal procedures to review and monitor personal data to ensure it is used responsibly and for what it was intended, and that we comply with internationally recognized standards of privacy and protection.
SAFE HARBOR: BBA complies with the U.S. European Union 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. BBA has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement. To learn more about the Safe Harbor Frameworks, please visit the U.S. Department of Commerce’s website at https://www.export.gov/safeharbor/. BBA’s certification to the Safe Harbor program can be found on this same website at https://safeharbor.export.gov/list.aspx
IT AND SECURITY: BBA maintains a high level of information technology security, particularly in relation to all of the personal data we collect. Precautions are taken to protect data from misuse, unauthorized access, alteration or destruction. BBA employs strict physical, electronic and managerial procedures to safeguard and secure the information we collect. BBA’s data from the clinical trials is stored in a special proprietary software program (if electronic), or stored in a secure and locked storage room (if paper) to which only authorized personnel directly involved with the trial can access on a need to know basis. Our offsite employees use a Virtual Private Network to access the secure servers, and data on the servers are restricted to those authorized employees on a need to know basis depending what type of work they are performing for BBA. Data and disaster recovery plans are part of our IT strategy.
HOW TO CONTACT US: To ask questions about this Privacy Statement or to exercise any rights you may have under privacy or data protection laws, you may contact us at 100 Crowley Drive, Suite 216, Marlborough, MA 01752 Attention: Privacy Officer, or firstname.lastname@example.org.