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Research spotlight: Understanding and correcting bias in RWE studies
Real-world evidence (RWE) studies are often criticized for their susceptibility to ...
How RWE can support drug development during COVID-19 and beyond: Q&A with Dr. Diana Brainard of Gilead Sciences
The COVID-19 pandemic introduced novel challenges for global biopharma organizations, as ...
How RWE can advance understanding of—and boost public confidence in—COVID-19 vaccine safety
After nearly one year of suffering, isolation, and economic downturn on an unprecedented ...
Opportunities to advance RWE in Europe: Assessing today’s landscape and priorities for future guidance
Real-world evidence (RWE) has emerged as an important tool for global regulators, health ...
How medical device companies can use RWE to drive impact for patients: Q&A with Christian Howell, Aetion’s VP/GM of Medical Devices and Diagnostics
For medical device manufacturers, real-world data (RWD) and real-world evidence (RWE) are ...
Sourcing global real-world data to support R&D: Q&A with Ian Rentsch, VP of Growth and Strategic Partnerships, Aetion
Biopharma organizations are working to incorporate real-world evidence (RWE) throughout ...
Real-world data in the era of COVID-19: Expert perspectives on the changing data landscape
The COVID-19 pandemic has brought forth a new era of collaboration between health care ...
Applying regulatory experience in the technology space: Q&A with Lowell Schiller, Chief Legal and Regulatory Officer at Aetion
Lowell Schiller, J.D., recently joined Aetion as Chief Legal and Regulatory Officer, ...
EMA-Approved application for ZOLGENSMA® (onasemnogene abeparvovec-xioi)
On March 26, 2020, the European Medicines Agency (EMA) approved AveXis’s ZOLGENSMA® ...
Research spotlight: Using RWE to evaluate complications of COVID-19
While COVID-19 is primarily a respiratory disease, its impact has also been associated ...
Interim results of the RCT-DUPLICATE Project: Dr. Jessica Franklin on learnings thus far
The RCT-DUPLICATE project began in 2018 with the goal of informing the use of real-world ...
CDER-Approved NDA for EVRYSDI™ (risdiplam)
On August 7, 2020, the FDA approved Genentech’s EVRYSDI™ (risdiplam) “for the treatment ...
CDER-Approved NDA for BLENREP (belantamab mafodotin-blmf)
On August 5, 2020, the FDA approved GlaxoSmithKline (GSK)’s BLENREP (belantamab ...
CDER-Approved NDA for VILTEPSO® (viltolarsen)
On August 12, 2020, the FDA approved Nippon Shinyaku’s VILTEPSO® (viltolarsen) for ...
RWE Guidance Watch: NICE updates methods for health technology evaluations
With real-world evidence (RWE) growing in influence across health care, regulatory and ...
Synthetic Clinical Trial Data: Use Cases, Methods, and Experiences
Stephen Bamford, Head of Clinical Data Standards & Transparency; IDAR, Global ...
Data Synthesis Platform Available for the PHUSE Community
By Kayley Phillpott Posted On: December 7th, 2020
CNIL Recommends Against US Service Providers for Processing Health Data – What Does that Mean?
Organizations processing the personal data of EU citizens, and data from France in ...
RWE Guidance Watch: MHRA draft guidance on RCTs generating RWE to support regulatory decisions
With real-world evidence (RWE) growing in influence across health care, regulatory and ...
How can real-world data support opioid addiction research? Q&A with Dr. Jacob “Gus” Crothers of Groups Recover Together
The opioid epidemic is one of the greatest public health challenges this century, and its ...
ICPE research spotlight: Part III: Standard-setting research to advance the use of RWE
This year at ICPE All Access, Aetion’s scientific research is represented across 15 ...
Optimal Synthesis of Clinical Trial Data
Khaled El Emam, SVP & GM, Replica Analytics