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28May
Federated Data Networks (FDNs): Enhancing the Quality of RWE Research
Real-World Data (RWD), from which Real-World Evidence (RWE) is generated, has the unique capability of depicting real-world outcomes. RWD can also reduce timelines for research and development, and generate profound […]
25May
How to Improve Transparency with Real World Data to Support Market Access?
The USFDA defines real-world data (RWD) as ‘the data relating to patient health status and/or the healthcare delivery that is routinely collected from a variety of sources’, and real-world evidence […]
23May
Unlocking the Power of RWE: Changing Scenario in the Global Landscape
There has been a shift in the global healthcare ecosystem from volume-based to value-based payment model, thanks to a surge in data availability, interoperability, advancing health technologies, cost and competitive […]
06May
The Role of Real World Evidence in Optimizing the Conduct of Clinical Trials
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 […]
27Apr
How to Prepare Real World Evidence for Regulatory Approval?
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, […]
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 […]
25Mar
Expanded Access Programme: an Important Initiative to Enhance Patient Access
Patients with serious, life-threatening health conditions and who have no available treatment alternatives, often want to know if and how they can receive early access to investigational products, sometimes even […]