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Evidence Hub

Blog
Jun 26, 2024

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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Blog
Jun 20, 2024

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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Blog
Jun 18, 2024

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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Publication
Jun 4, 2024

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, ...
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On-Demand Webinar
May 22, 2024

Clinical Development Webinar | June 20, 2024

Watch the webinar on-demand: Strategic Use of Real-World Data to Support Clinical ...
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Blog
May 6, 2024

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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On-Demand Webinar
May 2, 2024

De-ID Complex Data Webinar | June 6, 2024

Watch the webinar Unlocking Real-World Data for Analysis: Experiences De-identifying ...
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On-Demand Webinar
May 1, 2024

Oncology RWD Webinar | May 29, 2024

Join the webinar The Goldilocks problem in oncology RWD: choosing the data that’s 'just ...
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On-Demand Webinar
Apr 22, 2024

Synthetic Data Webinar | May 15, 2024

Watch the webinar The Replicability of Analysis Results Using Synthetic Clinical Trial ...
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Blog
Apr 20, 2024

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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Case Study
Apr 19, 2024

Case Study: Enhancing clinical trial data sharing with synthetic datasets

Unlock the future of research with our groundbreaking approach to privacy-preserving data ...
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Case Study
Apr 19, 2024

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 ...
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Case Study
Apr 19, 2024

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) ...
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Whitepaper
Apr 19, 2024

Whitepaper: RWE as Confirmatory Evidence for Accelerated Approvals

Since 1992, the FDA has paved the way for life-saving medicines to reach patients swiftly ...
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Blog
Apr 3, 2024

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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Publication
Mar 24, 2024

An evaluation of the replicability of analyses using synthetic health data

This paper published in Scientific Reports describes a study evaluating the replicability ...
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Blog
Mar 21, 2024

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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Presentation
Dec 13, 2023

Ten Things I have Learned About Synthetic Data Generation

Khaled El Emam, SVP & GM, Replica Analytics
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Blog
Dec 7, 2023

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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Presentation
Nov 30, 2023

Synthetic Data Summit 2023 | Session 2: Perspectives from Health Regulators

Title: High-Fidelity Synthetic Data Applications for Data Augmentation
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Presentation
Nov 30, 2023

Synthetic Data Summit 2023 | Session 5: Applications in Complex Healthcare Settings

Title: Generating Synthetic Data for the NHS
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Presentation
Nov 30, 2023

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 ...
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Presentation
Nov 30, 2023

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 ...
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Presentation
Nov 30, 2023

Synthetic Data Summit 2023 | Welcome / Opening remarks

Speaker: Khaled El Emam GM and SVP, Replica Analytics; Professor, University of Ottawa
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