PharmaSUG2025paper·US·Strategic Implementation & Innovation
Navigating Compliance Excellence: ISO Standards & Data Privacy Implementation SI-066
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PharmaSUG2025paper·US·Strategic Implementation & Innovation
Approaches to Developing Multiple Imputation ADaM Datasets SI-084
PharmaSUG2025paper·US·Strategic Implementation & Innovation
Decoding the Role of Statistical Programming – A Decade of Keytruda Submissions and Approvals SI-112
PharmaSUG2025paper·US·Strategic Implementation & Innovation
Navigating the transition of legacy processes for SDTM creation SI-159
PharmaSUG2025paper·US·Strategic Implementation & Innovation
SDTM Transformation through Artificial Intelligence (AI) and Human in the Loop (HITL): Lessons Learnt from Abbvie Case Study SI-180
PharmaSUG2025paper·US·Strategic Implementation & Innovation
Build vs. Buy: Strategic Considerations for Implementing AI Solutions in Pharma and Biotech Companies SI-206
PharmaSUG2025paper·US·Strategic Implementation & Innovation
Elevating Clinical Research: Strategic Implementation of CDASH and SDTM Standards SI-224
PharmaSUG2025paper·US·Strategic Implementation & Innovation
Stop Making More Physical Copies of Your Data: A Modern Approach to Traceability and Fidelity SI-225
PharmaSUG2025paper·US·Strategic Implementation & Innovation
Transitioning External Clinical Studies to Internal: A Framework for Knowledge Transfer and Operational Excellence SI-253
PharmaSUG2025paper·US·Strategic Implementation & Innovation
Integration Contemplation: Considerations for a Successful ISS/ISE from Planning to Execution SI-292
PharmaSUG2025paper·US·Strategic Implementation & Innovation
A Game Changer for Efficient SAS Programming using ChatGPT SI-294
PharmaSUG2025paper·US·Strategic Implementation & Innovation
Comparing SQL and Graph Database Query Methods for Answering Clinical Trial Questions with LLM-Powered Pipelines SI-342
PharmaSUG2025paper·US·Strategic Implementation & Innovation
An Introduction to the Role of Statistical Programming in Medical Affairs SI-359
PharmaSUG2025paper·US·Strategic Implementation & Innovation
Towards an Integrated Submission-Ready Data Pipeline: Unifying Compliance, Automation, and Open-Source Innovation SI-380
PharmaSUG2025paper·US·Submission Standards
Identification of Domains Containing Screen Failure Participants in SDTMs and ADaMs for Reviewer’s Guides SS-070
PharmaSUG2025paper·US·Submission Standards
A collaborative and agile approach for end to end Standards Governance and Release SS-087
PharmaSUG2025paper·US·Submission Standards
PDFs Done Right: The Statistical Programmer’s Guide to Flawless Regulatory Submissions SS-127
PharmaSUG2025paper·US·Submission Standards
Evaluation of the Process to Create CLINSITE define.xml: Macro Approach vs. ADCLIN Spec SS-135
PharmaSUG2025paper·US·Submission Standards
Handling Health Regulatory Information Requests: Best Practices and Strategies SS-146
PharmaSUG2025paper·US·Submission Standards
A 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-165