Real World Evidence
Evaluate drug utilization and outcomes in real world clinical practice settings
We generate robust real-world evidence to meet the rigorous demands of regulators, payers, and healthcare practitioners. Our strategic consulting can inform your decision on the type of research design and the best source of data to meet your stakeholders' need in a timely and efficient manner. With access to specialty data on a variety of disease states we can facilitate accelerated time to publication and scientific communications.
With more than 25 years of experience in Life Sciences research, we are knowledgeable of guidelines for conduct of robust studies that would be acceptable to all our stakeholders. There’s no challenge too big or too small, and we dedicate our utmost energy to every project we take on.
Every customer is unique. We pride ourselves in our extensive experience across a wide array of therapeutic areas including drug and device interventions in US and globally.
What SBC Clients Can Expect
Star Biopharma Consulting (SBC) clients embrace RWE generation from an integrated cross-functional perspective with the goal of addressing evidence requirements from various decision makers. A shift to a more data driven mindset and partnership that allows for flexibility in development of a roadmap for evidence generation we deliver in a timely fashion. Evidence planning for products span discovery through launch. Our work will be critical in enabling you to remain leading players within an increasingly digitalized healthcare industry.
Star Biopharma Consulting's Real World Evidence comes in a variety of forms from multiple, heterogeneous, and rapidly proliferating RWD sources. It includes all information generated in routine medical practice: electronic health health records, claims data, pharmacy data, and clinical outcomes reported by patients. It includes epidemiological data, registry data, health survey data, and data collected during observational trials and pragmatic studies. In order to remain competitive in a value-based, personalized healthcare system, you can expect RWE services, which will provide large growth opportunity in the market.
SBC Evidence from real-world practice and utilization outside of clinical trials will help tailor healthcare decision-making more closely to the characteristics of individual patients, and thus as a step towards making healthcare more personalized and effective. Robust RWE will not only tap increasing volumes of data, but weave together different sources of data to provide a more complete picture of the disease and its management including disparities in healthcare access and outcomes. All research is tailored to the evidence needs of the stakeholders aligned with prioritized evidence gaps that will help inform decision makers.
In the pharmaceutical industry, the overarching goal is to bring drugs and devices to market faster that improve health outcomes for patients. Once approved, additional research is needed to ensure appropriate utilization to maximize health benefits and reduce overall cost of care. RWE provides insights into how a drug is used and how it performs in the “real world” in a broader population of patients than those included in clinical trials. Historically RWD were utilized in post authorization safety only but more recently use of RWD has become acceptable and sometimes necessary in regulatory evaluations.
