Blog
Efficient Synthesis of Complex Health Data
Blog authored by Lucy Mosquera (Sr. Director, Generate Operations and Data Science) and ...
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Advancing SMA Treatment: How Real-World Evidence Supports Regulatory Decisions
Spinal Muscular Atrophy (SMA) is a rare and debilitating neuromuscular disease affecting ...
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Quality, Rigor, and Transparency: The RWE Imperative
Over the past year, news stories have focused on high-profile missteps or fraud in the ...
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The Evolving Role of Observational Studies in Healthcare: Enhancing Payer Utility and Impact
Blog authored by Ashley Jaksa (VP, Scientific Strategy & Partnerships) and Pat Arena ...
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Navigating the European Union's Medical Device Regulation (MDR)
On May 26, 2021 the European Union’s (EU) Medical Device Regulation (MDR) became ...
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How to unleash the replicability potential of synthetic data
In today's data-driven world, the need for innovative solutions to evolve alongside the ...
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Key Takeaways from the public workshop, “Advancing Real-World Data to Generate Regulatory Grade Real-World Evidence in Oncology”
By Inish O’Doherty and Purva Jain
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FDA releases draft guidance on non-interventional studies for drug and biological products
The Food and Drug Administration (FDA) continues to advance its RWE Program, this time ...
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Aetion’s comments to FDA on recent draft guidance on the substantial evidence standard
This week, Aetion submitted a letter to FDA commenting on the Agency’s recent draft ...
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Research Spotlight: A Deep Dive into a Real-World Reproducibility Study
Both real-world data (RWD) and real-world evidence (RWE) studies continue to effectively ...
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Partnering to enhance Japanese RWD at a global scale: A Q&A with JMDC
JMDC, a leading Japanese health big data firm, and Aetion® recently announced a ...
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Research Spotlight: Navigating Treatment Effectiveness in Rare Oncology with External Control Cohorts
Real-world data (RWD) has proven to be a pivotal tool in understanding patient treatment ...
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What I saw at DIA RWE 2023
I am just back from Baltimore, Maryland, where I had the joy of attending DIA’s ...
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Advancing RWE in Oncology with Aetion’s CARE Initiative
In late 2022, Aetion announced the launch of the Aetion Coalition to Advance Real‐World ...
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What I saw at ICPE 2023
I just had the pleasure and privilege of attending the 39th International Conference on ...
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Leveraging the SURF screening tool to understand how to identify whether RWE of effectiveness may be acceptable for regulatory decision-making for a clinical development program
Ulka Campbell, Ph.D., is Aetion’s Head of Scientific Strategy. In this role, she uses her ...
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The Inflation Reduction Act Puts Real-World Evidence Front and Center
The drug price negotiation provisions of the Inflation Reduction Act (IRA) will ...
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Implementation of synthetic data generation in the enterprise
By Khaled El Emam | Published: April, 2023 The following article was published by ...
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Aetion submits comments to FDA on recent draft guidance on considerations for externally controlled trials
Earlier this week, Aetion submitted a letter to FDA commenting on the Agency’s recent ...
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Setting Real-World Standards at ISPOR 2023
Aetion joins other industry experts at ISPOR 2023 to discuss standard-setting and ...
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Scientist spotlight: A deeper dive on RCT-DUPLICATE
This week, the final results of the RCT-DUPLICATE (RCT-D) study were published in the ...
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Privacy Assurance FAQ
What is Privacy Assurance? One of the benefits of synthetic data is that it has low ...
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Synthetic Data Generation FAQ
What is synthetic data generation (SDG)? There are many ways to generate synthetic data. ...
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Aetion® Generate FAQ
What is Generate? Aetion® Generate, formerly Replica Synthesis, is Aetion’s scalable ...