Prospective Observational Research (including registries and safety surveillance)
Post-approval, observational studies can be used to address questions pertaining to safety surveillance, risk management, and efficacy. Correct study choice and effective execution are paramount to achieving the desired goals. The purpose of a disease registry is to gather uniform clinical data that will be used to evaluate the outcomes for a population defined by a particular disease, condition, or exposure (treatment). The longitudinal nature of registries allow for the examination of patterns of co-morbidities, course of the disease, physician’s diagnosis, and treatment concerns and overall practice patterns. The registry information can be used to determine ways to optimize measures of disease impact and to understand the space where product will be used and the potential impact of the product.
We work closely with our clients throughout all stages of implementation, specializing in the management and analyses of observational research data. Our proven registry approach includes defining goals and objectives, identifying data collection approaches, analyzing data, exploring federal and regulatory requirements, and developing a comprehensive plan for site and patient recruitment.
The continuous support and close monitoring we provide in every registry allows us to respond promptly to shifting marketplace needs as they arise over the course of the study. The data collected in the registry provide the basis for medical communications and publications that can bolster the scientific objectives of our clients. To ensure community awareness and acceptance of the results, we often lead discussions with opinion leaders and advisory panels to gather input on the design, execution, and the publication plan for the registry.
