Optimizing the Use of Data Standards

Working Group Description

The development and adoption of data standards – spanning data models, terminologies, metadata, and an expanding array of digital, real-world and emerging data types – have improved the efficiency of data generation, exchange, and regulatory review across healthcare and life sciences. As the volume, variety and complexity of data continue to grow, so too does the number of standards required to support them, which creates new opportunities as well as added complexity. Despite this progress, gaps, inconsistencies and challenges persist in the interpretation, implementation and integration of these standards across regions, stakeholders and technology platforms.

This Working Group will identify and prioritise key gaps and challenges that limit the optimal, consistent and scalable use of data standards across the global ecosystem. Through cross-sector collaboration, the group will work to advance alignment across standards, support the integration of emerging data types, promote innovation, and enable more effective, interoperable and technology-enabled use of standards to support decision-making, regulatory processes and lifecycle management.

Current Projects

Bioresearch Monitoring (BIMO) Frequently Asked Questions Forum

Building a Better MDR

Clinical Integrated Study Data & Analysis Data Reviewer's Guide

Electronic Data Submission in Japan

Management of ODS Regulatory Referenced Deliverables 

SDTM ADaM Implementation FAQ

Open

Carlo Radovsky is a clinical data standards consultant, with more than three decades of pharmaceutical industry experience spanning data management, statistical programming and standards governance. With a passion for connecting the technical detail of clinical data to the strategic needs of the enterprise, he has helped organisations build standards programs that align with regulatory expectations and scale with the business.

An active contributor to CDISC (since 2008) and PHUSE (since 2022), Carlo offers a history of establishing enterprise-wide standards, engaging vendors from both the business and supplier perspectives, and driving regulatory submission readiness across a wide range of organisations. His belief is that standards succeed when they make the work easier, not heavier, through governance people will actually follow, training that lands for both technical and non-technical audiences, and workflows that prioritise judgement rather than repetition.

Open

Sandra (Sandy) VanPelt Nguyen has been working in clinical research for over 20 years in roles in data management, clinical/statistical programming, and data standards across multiple therapeutic areas. She has been involved in data standards implementation and governance in many of those roles, and has about 20 years’ experience working with CDISC standards.

Sandy has been involved with PHUSE since 2015, leading and supporting PHUSE projects under the Optimizing the Use of Data Standards and Real World Evidence Working Groups. As a life-long learner, Sandy enjoys these types of collaborative projects along with other opportunities to share and learn. She regularly presents at conferences such as the PHUSE CSS, the PHUSE Connects and PharmaSUG.

Sandy currently works at Pfizer as a Director in the Submissions and Standards team, focused on end-to-end data standards implementation, governance, and optimisation.

Open

Matt Baldwin has extensive experience in clinical data standards, biometrics and data governance, helping organisations establish consistent, analysis-ready, AI-ready and submission-ready clinical data across both randomised clinical trials and real-world evidence studies. Matt has worked across biopharma, CRO and clinical technology environments. He recently joined CSL Behring in their Technology Enabled Science (TES) Data Excellence team as Senior Manager, R&D Data Stewardship. He has volunteered with PHUSE since 2022 across multiple Working Groups and project teams.