Non-interventional research encompasses several study designs in which groups of patients are observed within routine clinical practices. In the biopharmaceutical and device industries, observational studies can offer valuable insights into the causal relationship between a drug product, device, or procedure and a specific event or outcome. These non-interventional studies have become important tools in health care research because they offer a wider range of methods to answering significant, “real world” clinical research and product usage questions. Several study designs fall within this category of epidemiology research including:
• Cohort studies, including potential patient registries
• Case-control studies, including reflective chart reviews; and
• Database studies using electronic health records or 3rd party databases

Our team of pharmacoepidemiologists, pharmacovigilance, regulatory, and research operations experts who can:
• Help you outline the needs of your target audience(s) and to develop the best study design to meet your research goals
• Define the ideal regulatory authority and ethics committee submission strategies
• Implement a study management and resourcing model trained to collect the required data in the most efficient manner and to agreed-upon standards of quality