NEST Releases New Data Quality and Research Methods Frameworks for RWE
A Practical Guide to Real-World Evidence (RWE) for Medical Devices
Since 2018, NEST has been leading the charge in transforming how real-world data (RWD) and real-world evidence (RWE) catalyze medical device innovation. With the launch of our Research Methods Framework and Data Quality Framework in 2020, we established the foundation for best practices in data quality and study design, helping stakeholders confidently execute RWE studies that support regulatory submissions. Now NEST is releasing version 2 of these frameworks.
What's New in Version 2:
Built on Our Experience
Application of lessons learned from both 21 groundbreaking NEST test-cases, one of which resulted in the first label expansion approved by CDRH for a medical device based on a comparative RWE study using solely EHR data, plus ongoing implementation cases.
Expanded Scope
The updated Frameworks now span a wider range of data sources, integrate the latest FDA draft RWD guidance, incorporate ecosystem feedback, and highlight new best practices and case examples to accelerate adoption.
Introduced the NEST Mark™ Process
An innovative approach that provides a structured, comprehensive assessment of RWD quality. The NEST Mark review is designed to build confidence for manufacturers, regulators, and stakeholders that data quality meets regulatory standards.
Download the Frameworks
NEST Data Quality Framework: A Practical Guide to Real-World Evidence (RWE) for Medical Devices
NEST Research Methods Framework: A Practical Guide to Real-World Evidence (RWE) for Medical Devices
How these Frameworks Support RWE Innovation in MedTech
These updates transform and elevate standards for data quality and research methods, helping stakeholders to:
- Support regulatory submissions with trusted, reliable data.
- Reduce resource needs and complexity to execute RWE studies.
- Demonstrate data quality with clear, transparent criteria recognized across the ecosystem.
- Drive innovation with Frameworks that evolve alongside the rapidly changing RWE landscape.
The updated Frameworks reflect the evolution of RWE innovation. They are designed to be a comprehensive resource for the medical device ecosystem- empowering stakeholders to harness RWD with confidence, efficiency, and impact. Don’t wait- explore the updated Frameworks today!