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PharmaSUG2025paper·US·Strategic Implementation & InnovationComparing SQL and Graph Database Query Methods for Answering Clinical Trial Questions with LLM-Powered Pipelines SI-342See metadata
PharmaSUG2025paper·US·Strategic Implementation & InnovationAn Introduction to the Role of Statistical Programming in Medical Affairs SI-359See metadata
PharmaSUG2025paper·US·Strategic Implementation & InnovationTowards an Integrated Submission-Ready Data Pipeline: Unifying Compliance, Automation, and Open-Source Innovation SI-380See metadata
PharmaSUG2025paper·US·Submission StandardsIdentification of Domains Containing Screen Failure Participants in SDTMs and ADaMs for Reviewer’s Guides SS-070See metadata
PharmaSUG2025paper·US·Submission StandardsA collaborative and agile approach for end to end Standards Governance and Release SS-087See metadata
PharmaSUG2025paper·US·Submission StandardsPDFs Done Right: The Statistical Programmer’s Guide to Flawless Regulatory Submissions SS-127See metadata
PharmaSUG2025paper·US·Submission StandardsEvaluation of the Process to Create CLINSITE define.xml: Macro Approach vs. ADCLIN Spec SS-135See metadata
PharmaSUG2025paper·US·Submission StandardsHandling Health Regulatory Information Requests: Best Practices and Strategies SS-146See metadata
PharmaSUG2025paper·US·Submission StandardsA Little Bit of This and That: Use cases, implementation, and documentation when using multiple CDISC standards, CTs, and regulatory guidances in an SDTM study SS-165See metadata
PharmaSUG2025paper·US·Submission StandardsKey guidelines, Tricks and Experiences for PMDA and comparison with FDA and CDE submission SS-254See metadata
PharmaSUG2025paper·US·Submission StandardsThe Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies SS-258See metadata
PharmaSUG2025paper·US·Submission StandardsExploring the Upcoming Integrated cSDRG! SS-269See metadata
PharmaSUG2025paper·US·Submission StandardsUpdating Define-XML packages: Tips and A Comprehensive Checklist SS-276See metadata
PharmaSUG2025paper·US·Submission StandardsADaM and TFLs for Drug-induced Liver Injury (DILI) Analysis SS-306See metadata
PharmaSUG2025paper·US·Submission StandardsChecking Outside the Box: A Framework for Submission Success SS-314See metadata
PharmaSUG2025paper·US·Submission StandardsLeveraging previous study data for Extension studies: Structuring Subject and Participant Level Analysis datasets using CRF data SS-333See metadata
PharmaSUG2025paper·US·Submission StandardsEnsuring Data Integrity: Techniques for Validating SDTM Datasets in Clinical Research SS-344See metadata
PharmaSUG2025paper·US·Submission StandardsCommon Issues in BIMO Clinical Site Dataset Packages SS-348See metadata