Blog
Quality, Rigor, and Transparency: The RWE Imperative
Over the past year, news stories have focused on high-profile missteps or fraud in the ...
Blog
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 ...
Publication
The potential role of real-world evidence in Centers for Medicare & Medicaid Services’ future price negotiations: Recommendations for a robust framework
In this article, authors Ashley Jaksa (VP, Scientific Strategy & Partnerships, ...
On-Demand Webinar
Clinical Development Webinar | June 20, 2024
Watch the webinar on-demand: Strategic Use of Real-World Data to Support Clinical ...
Blog
Navigating the European Union's Medical Device Regulation (MDR)
On May 26, 2021 the European Union’s (EU) Medical Device Regulation (MDR) became ...
On-Demand Webinar
De-ID Complex Data Webinar | June 6, 2024
Watch the webinar Unlocking Real-World Data for Analysis: Experiences De-identifying ...
On-Demand Webinar
Oncology RWD Webinar | May 29, 2024
Join the webinar The Goldilocks problem in oncology RWD: choosing the data that’s 'just ...
On-Demand Webinar
Synthetic Data Webinar | May 15, 2024
Watch the webinar The Replicability of Analysis Results Using Synthetic Clinical Trial ...
Blog
How to unleash the replicability potential of synthetic data
In today's data-driven world, the need for innovative solutions to evolve alongside the ...
Case Study
Case Study: Enhancing clinical trial data sharing with synthetic datasets
Unlock the future of research with our groundbreaking approach to privacy-preserving data ...
Case Study
Case Study. Data Guardian: Securing Enterprise Health Data through an Advanced Risk Assessment and De-Identification Solution
Our case study explores how our client, a leading American retail company, and its ...
Case Study
Case Study: Unlock the Replicability Power of Synthetic Data in Health Research – with Practical and Reliable Guidelines
Embark on a journey to harness the full potential of Synthetic Data Generation (SDG) ...
Whitepaper
Whitepaper: RWE as Confirmatory Evidence for Accelerated Approvals
Since 1992, the FDA has paved the way for life-saving medicines to reach patients swiftly ...
Blog
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
Publication
An evaluation of the replicability of analyses using synthetic health data
This paper published in Scientific Reports describes a study evaluating the replicability ...
Blog
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 ...
Presentation
Ten Things I have Learned About Synthetic Data Generation
Khaled El Emam, SVP & GM, Replica Analytics
Blog
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 ...
Presentation
Synthetic Data Summit 2023 | Session 2: Perspectives from Health Regulators
Title: High-Fidelity Synthetic Data Applications for Data Augmentation
Presentation
Synthetic Data Summit 2023 | Session 5: Applications in Complex Healthcare Settings
Title: Generating Synthetic Data for the NHS
Presentation
Synthetic Data Summit 2023 | Session 4: Applications of Synthetic Data in the Life Sciences Industry II
Title: Applications of Privacy Enhancing Technology to Data Sharing at a Global ...
Presentation
Synthetic Data Summit 2023 | Session 3: Applications of Synthetic Data in the Life Sciences Industry I
Title: Applications of Synthetic Data in Supporting Data Products and Analytics for Real ...
Presentation
Synthetic Data Summit 2023 | Welcome / Opening remarks
Speaker: Khaled El Emam GM and SVP, Replica Analytics; Professor, University of Ottawa
Presentation
Synthetic Data Summit 2023 | Session 1: Regulating Privacy Risks from Synthetic Data
Title: Assessing the Privacy Risks of Synthetic Data and Other PETs