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21Apr
The Importance of Communicating the Value of Real World Evidence to Stakeholders
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 […]
13Apr
Big Data in Medicine and Artificial Intelligence: A Real World Challenge?
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, […]
08Apr
An Overview of Registry Studies and Considerations for Regulators
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 […]
03Nov
The Real World Evidence Registry by ISPOR: an Initiative to Enhance Transparency
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 […]
04Oct
How Real World Data (RWD) can Support Conducting Smarter Clinical Trials
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 […]
21Oct
The Contribution of Wearables Towards Healthcare Evidence Generation
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 […]
24Oct
How RWE can Impact Clinical Trial Design and Help in Decision Making?
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 […]
28May
Tapping Payers’ Data to Document the Effect of a New Therapy in the Real World
Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability to the regulatory agencies, used to be simple; which ended with the drug being marketed to the targeted physicians and dispensed by pharmacies post approval. Thus, this whole process involved a limited set of stakeholders, viz. physicians, regulatory agencies, and pharmacies.
03Apr
Importance of Tapping Payer’s Data to Document the Effect of a New Therapy
Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability […]