UBC is a leader in safety and risk management strategies and systems to guide the use of biopharmaceuticals, medical devices, and other health care products. Our experts in product safety, risk management, epidemiology, and health policy collaborate with an array of health system stakeholders, including providers, regulators, payers, and manufacturers to identify, assess, and address issues that may impact patient safety.
We help protect patients and address regulatory requirements by designing and implementing Risk Evaluation and Mitigation Strategies and Risk Management Plans. UBC has unsurpassed experience developing and executing product safety and risk management programs, such as observational risk assessment studies – or registries – and comprehensive pharmacovigilance and safety monitoring programs.
UBC safety and risk management programs are designed by recognized experts, executed by industry-leading research operations professionals, and supported by reliable, customized technologies including our state-of-the-art Risk Management Coordinating Center. Our systems and technologies are tailored to address individual project needs and are designed to comply with key industry guidelines and regulations, including 21 CFR Part 11 and HIPAA.
