The development and adoption of data standards over the last decade has shown significant promise in improving efficient delivery of data to support drug product and device submissions as well as the review process. However, there have also been gaps, issues and challenges in the interpretation and use of data standards. This working group will identify specific gaps that prevent FDA and industry from optimizing the use of data standards. This working group will collaborate to close those gaps. On this page you will find information on Current and Completed projects.
Working Group Leads
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 Standardizing 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. | Jane Lozano:  Data Strategist/ConsultantClinical Design, Delivery, & Analytics, Eli Lilly and CompanyJane has been a part of the pharmaceutical industry for over twenty-five years. She has been employed at Lilly since 1994 and has worked on early phase and late phase trials for multiple therapeutic areas from a data perspective. She has an in depth understanding of end to end global clinical data sciences and clinical data management, including data base structures, data collection methods, data flow management, data analytics and automation, data quality and integrity, data technology, data archiving, data standards, data integration, data mapping and data submission. |
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