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Elisabeth Pyle

6 papers; 6 titles; 4 coauthors.

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Conference × Year × Title × Co-authors Extras Pages
PHUSE US 2026 Enhancing Clinical Study Report Authoring with Generative AI: Lessons Learned on TFL Formatting and Metadata Integration in Merck's iRAP Tool Madhusudhan Reddy Papasani source
presentation source		 4
PHUSE US 2025 Management of Regulatory Submissions Using eCTD Sequences and Life Cycle Operators: Lessons from Real-Time Oncology Review (RTOR) and Regular Submissions Madhusudhan Reddy Papasani,
Mary N. Varughese		 source
presentation source		 8
PHUSE US 2022 Collection, Standardization, and Reporting of Adverse Events with Toxicity Changes Using CDISC Standards in Oncology Clinical Trials Madhusudhan Reddy Papasani,
Swathi Kotla		 source
video
presentation source		 12
PharmaSUG 2021 Neoadjuvant and Adjuvant Oncology Clinical Trials and Considerations for Designing the Subject Level Analysis Dataset (ADSL) Madhusudhan Reddy Papasani,
Swathi Kotla		 source 9
NESUG 2009 A Proposed SDTM Implementation of Response Data for Solid Tumor Trials in Oncology Mei Dey 18
NESUG 2007 ODS, An Introduction to Creating Output Data Sets 7

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