Optimizing the Use of Data Standards
Working Group Scope |
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. |
Janet Low Janet Low is a Statistical Programmer at Merck where she is focused on study data standards and ensuring that electronic submission deliverables are high-quality and aligned with regulatory submission requirements. Nearly 20 years at Merck, Janet has worked in data management and statistical programming, but she is most passionate about leveraging her M.S. in Quality Assurance and Regulatory Affairs from Temple University to guide teams to submission and audit readiness. She has provided operational excellence with training, consultation and mentorship to teams in a broad array of therapeutic areas covering drugs and vaccines; early to late stage clinical development; and partnership and collaborations. In 2019, Janet joined as a co-lead to PHUSE Optimizing the Use of Data Standards Working Group. Prior to her role, she was an active volunteer in PHUSE projects and publications since 2015, including Standardising Data within the Inspection Site Selection Process, SDSP, Industry Experiences Submitting Standardised Study Data to Regulatory Authorities and Clinical Integrated Study Data and Analysis Data Reviewers Guides. When Janet is not behind a computer, you’ll find her volunteering in her community and cooking international dishes. | Sandra VanPelt Nguyen 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.
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