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An update on efforts to standardize and democratize RWE: Q&A with Dr. Nirosha Mahendraratnam Lederer
As real-world evidence (RWE) adoption continues to ramp up across health care, ...
Research spotlight: Gilead Sciences and Aetion use RWE to assess the comparative effectiveness of remdesivir for COVID-19
As COVID-19 continues to evolve, frontline health care workers are eager for real-world ...
CBER-Approved BLA for ABECMA® (idecabtagene vicleucel)
On March 26, 2021, FDA approved Celgene’s BLA for ABECMA® (idecabtagene vicleucel) for ...
CDER-Approved sBLA for ERBITUX® (cetuximab)
On April 6, 2021, FDA approved a new biweekly dosing regimen for Eli Lilly’s ERBITUX® ...
Using RWE to characterize diseases as novel treatments become available: Q&A with Dr. Maria Schneeweiss
As novel therapies come to market, especially in disease areas that aren’t as well ...
Research spotlight: Using RWD sources to describe the patient burden of a poorly understood rare disease
This month, Aetion and Boehringer Ingelheim published two co-authored papers which ...
CDER-Approved NDA for LAMPIT® (nifurtimox)
On August 6, 2020, FDA granted accelerated approval to Bayer Healthcare’s LAMPIT® ...
Implementing the FAIR Data Sharing Principles
Experiences Implementing Data Synthesis in a Global Life Sciences Company
Data Synthesis: A Tool for Responsible Data Sharing
Research spotlight: Organized structure of RWE best practices
In the last five to 10 years, stakeholders from around the globe have launched ...
How NICE is approaching guidelines for RWE generation: Q&A with Dr. Páll Jónsson
In its recently announced five-year strategy, the UK’s National Institute for Health and ...
Introducing the RWE Alliance: How a cross-industry coalition aims to advance RWE policy
The last several years have been foundational in the effort to advance the use of ...
How leading-edge teams are using RWE to accelerate drug development: A conversation with Janssen R&D and Sanofi
The majority of biopharma organizations are investing in real-world evidence (RWE) ...
How payers and providers can leverage RWE: Q&A with Bill Guptail, SVP of Value-Based Care, Aetion
As payers and providers continue to navigate value-based agreements and strive to improve ...
Evaluating the Utility of Synthetic COVID-19 Case Data
How using an RWE platform can support building regulatory-grade ECAs
An external control arm (ECA) study is a cutting-edge pharmacoepidemiologic design that ...
RWE plays an integral role in NICE’s five-year strategy
For the UK’s National Institute for Health and Care Excellence (NICE) the COVID-19 ...
How RWE can support safety in Europe: Dr. Pierre Engel on leveraging innovative strategies to meet regulatory requirements
In Europe as in the U.S., biopharma organizations, regulators, and health technology ...
Can Synthetic Data Be A Proxy For Real Clinical Trial Data? A Validation Study
Research spotlight: Using RWE to assess molecular insights, published in Science
Earlier this year, Aetion co-authored a study published in Science that demonstrates how ...
Leveraging RWE in regulatory submissions of medical devices: Three takeaways for medical device and diagnostic companies
The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological ...
Research spotlight: Using RWD to evaluate risk of COVID-19 reinfection
To date, approximately 66 million patients have recovered from COVID-19, globally. As the ...
CDER-Approved NDA for VEKLURY® (remdesivir)
On October 22, 2020, the FDA approved Gilead Sciences’s VEKLURY® (remdesivir) for the ...