Real-world evidence (RWE) is derived from real-world data (RWD) sources, such as electronic health records (EHRs), claims data, data from product/disease registries, pharmacy data, social media, and pragmatic trials. RWE […]
Drug makers usually put in rigorous efforts to fast-track and reduce the cost burden of regulatory decision-making by regulatory authorities like USFDA and EMA. As a part of these efforts, […]
Real-world evidence (RWE) has been used extensively for satisfying post-launch regulatory requirements, mainly about drug safety. Of late, it has been realized that RWE has a wide range of applications […]
Artificial Intelligence (AI) refers to a computerized system that performs physical tasks, cognitive functions, solves problems, and/ or makes decisions without overt human instructions.[1] First proposed by McCarthy in 1955, […]
A patient registry has been defined as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined […]
The world today is observing an exponential growth in the volume and variety of the real-world data (RWD). Thanks to the technological advancements and the rise in the use of […]
In a data-driven world, where everything can be digitalized, drug regulators and sponsors are increasingly looking beyond the confines of clinical trials. The use of real-world data (RWD) is becoming […]
The health and fitness wearable market is on the rise since the last few years. Analysts expect that by 2020, almost half a billion smart wearable devices will have been […]
Real-world evidence (RWE) research is gaining significant importance in biopharmaceutical product development as well as its commercialization. The increasing need of the industry to seek broader information about the safety […]