Quality and Reusability of Real World Data

Project Description 

This project focuses on evaluating real-world data (RWD) sources for regulatory use and identifying the documentation needed to support FDA pre-alignment discussions. It will assess available data sources, summarise their advantages and limitations, and outline the requirements for demonstrating data quality, traceability, appropriateness and regulatory readiness. 

RWD has long supported research planning, site and patient selection, safety follow-up and market access, but its use in regulatory submissions requires a more rigorous and structured approach. Sponsors must be able to justify their choice of data source, confirm its representativeness and reliability, and provide robust evidence to support study assumptions. 

The project will develop practical guidance on selecting suitable data sources, evaluating quality, and preparing key supporting documents for regulatory engagement. Where possible, it will seek alignment with FDA expectations. The outputs will help organisations strengthen study design early, reduce the risk of rejection, and improve readiness for RWD-based regulatory submissions. 

Ashwin Rai, Thermo Fisher Scientific 

ashwin.rai@thermofisher.com

Berber Snoeijer, ClinLine

b.snoeijer@clinline.eu

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global 

Understanding the Data Quality Issues in Real World Data through Real World Examples

Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products

RWD: The FDA’s Guidance on Assessing Registry Data to Support Regulatory Decision-Making