BASEL, Switzerland – Having a common data structure has been a “major enabler” of the EU’s DARWIN network, allowing real-world evidence (RWE) studies to be conducted rapidly. This has facilitated a ...

The Covid-19 pandemic impacted virtually every industry, with healthcare arguably undergoing the most drastic transformation. Pre-pandemic, most of us never could’ve imagined routine doctor visits ...

Reacting to new regulatory draft guidance on observational studies, stakeholders asked the US Food and Drug Administration (FDA) to flesh out its advice with examples and to ensure consistency with ...

NEW YORK, April 25, 2023 ‒ Aetion ®, the global leader in real-world evidence (RWE) technology and analytics, is pleased to announce the culmination of the RCT-DUPLICATE demonstration project, with ...

Real-world evidence helps pharmaceutical companies and payers communicate more effectively. In this Q&A, Cate Lockhart, PharmD, PhD, chief science officer of the Academy of Managed Care Pharmacy (AMCP ...

FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of ...

The FDA’s final guidance for the use of real-world evidence (RWE) was touted by FDA commissioner Marty Makary as opening the door to the use of existing de-identified data in premarket device ...

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- IQVIA™ (NYSE: IQV) announces its strategic collaboration with HealthCore, Inc., a leading real world research organization in the United States, to ...

RWD comprises various data gathered outside of traditional clinical research settings. This includes electronic health records (EHRs), insurance claims, patient registries and wearable device data.

WASHINGTON--(BUSINESS WIRE)--Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration (FDA) draft guidance on using electronic health records ...