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82 papers and 15 presentations; 93 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG CN 2026 DQO: A Rule Engineering and AI-Driven Platform for Assessing Source Data Quality from SDTM Perspective Nana Yang,
Huan Song,
Zhouhao Pan,
Chunpeng CZ Zhao		 source 11
PharmaSUG CN 2026 Leading Through Complexity: A Compound Lead Perspective on Planning, Coordination, and Quality Control Fuyuan Pang source 4
PharmaSUG 2026 Automated Delta Detection: A Scalable R-Shiny Framework for Comparing Clinical Datasets Prabhakara Rao Burma,
Latha Donapati		 source 7
PharmaSUG 2026 Delegation as a Quality Strategy: Building Accountable Biometrics Teams Steven Tan source 5
PharmaSUG 2026 Early Unblinding to Pharmacometrics (PMx) Data: Challenges, Practices, and Benefits Shweta Vadhavkar,
Jing Su		 source 6
PharmaSUG 2026 One Study, Many Regulators: Submission-Ready Data Package for Multi-Region Filings Himanshu Patel,
Chintan Pandya		 source 10
PharmaSUG 2026 Post-DBL Programming Update Tracker: Automating Revision Capture to Strengthen Audit Readiness, Oversight, and Compliance Across Programs and ADaM Specifications Yunyi Jiang,
Christine S Teng		 source 8
PHUSE US 2026 Blind/Unblind Workflows: Secure Separation and Governance in the CDR SCE Kala Shivali,
Sachin Walawalkar		 source
presentation source		 11
PHUSE US 2026 C&SP 203X Reinventing Clinical & Statistical programming for the AI - era [presentation] Sangeeta Bhattacharya source 19
PHUSE US 2026 Digital Twins for Clinical Submissions: Simulating Regulatory Review Before Submission Heather Gorr,
Divya Kapoor		 source
presentation source		 9
PHUSE US 2026 From Demo to Deployment: Bridging the AI Implementation Gap Melanie Hullings,
Emily Yates		 source
presentation source		 5
PHUSE US 2026 Level Up: Change Management Skills as Your Career Accelerator [presentation] Aga Rasinska source 13
PHUSE APAC 2026 Beyond Code: Elevating NextGen Statistical Programmers through Cross-Functional Learnings Saumil Tripathi source
presentation source		 7
PHUSE APAC 2026 Critical & Sensitive Information (CSI) Paper AS02 Revolutionizing Clinical Quality: A Frontier Approach with Quality by Design (QbD), Infrastructure Modernization and Data-Driven Analytics Priti Gupta,
Deepa Balaji		 source
presentation source		 12
PHUSE APAC 2026 End-to-End Continuous Integration and Deployment Pipeline for Multi Language Analytics Applications: A Clinical Data Management Case Study Avinash Patnaik,
Varun Sethuraman		 source
presentation source		 7
PHUSE APAC 2026 Optimising Few-Shot Prompting Strategies for Scalable and Reliable Enterprise AI Applications Varun Sethuraman,
Avinash Patnaik		 source
presentation source		 10
PHUSE APAC 2026 Seamless Reproducibility: Version-Aware Global Macro Invocation in Statistical Computing Environments Piyusha Mathur,
Shilpa Sood		 source
presentation source		 6
PHUSE EU 2025 Disruption in Clinical Trials: How Conventional Roles Are Set to Change Amit Javkhedkar,
Kala Shivali		 source
presentation source		 7
PHUSE EU 2025 Qualitative ADaM Datasets and Define-XML Without Using ADaM Specs Pieter Coppens source
presentation source		 4
PharmaSUG 2025 Bridging the Gap: Leadership of Statistical Programmers in Clinical Trials Allison Covucci,
Xiaohan Zou		 source 6
PharmaSUG 2025 Data management and biostatistics synergy: how to achieve and what can be expected Diana Avetisian source 11
PHUSE US 2025 Enhancing Data Accuracy and Collaboration Through Efficient Data Reconciliation Using SAS in Clinical Trials Piyush Makkapati,
Swathi Nattam		 source
presentation source		 8
PHUSE US 2025 Topline Considerations for Double-Blind Trials Veena Palle,
Naresh Gopalkrishna		 source
poster source		 5
PHUSE EU 2024 Bridging Statistical Programming and Data Management: A Job Rotation Experience Frederikke Høyer source 4
PHUSE EU 2024 How Agile Can you Be? Looking at Statistical Programming as a Software Development Process Oliver Wirtz,
Peter Bonata		 source
presentation source		 6
PharmaSUG 2024 Effectively Manage the Programming Team Using Microsoft Teams Jeff Xia,
Simiao Ye		 source 7
PharmaSUG 2024 The Role of the Blinded Programmer in Preparation of Data Monitoring Committee Packages (for Clinical Trials) Binal Mehta,
Patel Mukesh		 source 6
PHUSE US 2024 Real-Time Data Cleaning -- A Reality: When Automation Connects Digitised, Centralised, Standardised Data, it Transforms into Real-Time Data Cleaning Vidya Muthukumar source
poster source		 2
PHUSE EU 2023 Taking down the fence between Biostatistics and Medical writing Rob Wartenhorst source
presentation source		 3
PharmaSUG 2023 F2: FAIR and Filing - Assessing Data Fitness for FAIR and Filing Bidhya Basnet,
Dyuthi Yellamraju		 source 7
PharmaSUG 2023 Study Data Technical Rejection Criteria (TRC) Considerations for Multiple Data Packages in a Single Submission Christine S Teng,
Janet Low,
Si Ru Tang		 source 10
PharmaSUG 2023 Submission survival guidelines for Statistical Programmers Mekhala Acharya,
Katlyn Buff,
Norihiko Oharu		 source 9
PHUSE US 2023 Submission Experience with Real-Time Oncology Review, Project Orbis, and Priority Review Anna Liu,
Sai Ma		 source
presentation source		 5
PHUSE EU 2022 F2 (FAIR and Filing) Dashboard [poster] Nigel Montgomery,
Bhupendra Mistry		 source 1
PharmaSUG 2022 Real Time Oncology Review Readiness from Programming Perspective Binal Mehta,
Patel Mukesh		 source 10
PHUSE US 2022 RBM - The New Normal Vigilante for CROs With AI and ML [presentation] Vidya Muthukumar source 18
PHUSE US 2022 Trial Summary SDTM Domain Made Easy for Regulatory Submissions [presentation] Kishore Pothuri source 16
PHUSE EU 2021 Software Demonstrations: elluminate Clinical Data Cloud - Automating Clinical Data from Ingestion to Actionable Insights - Sponsored by eClinical Solutions [presentation] Achilleas Zaras source 9
PHUSE US 2021 Onboarding a junior Clinical Data Manager (CMD) in an Early Phase Team: My Story from University to First Database Lock [presentation] Glenn Borgmans,
Sofie Stynen		 source
video		 30
PHUSE US 2021 Process Optimization for Submissions Participating in the FDA's Real Time Oncology Review Pilot Program [poster] Grace Sun,
Kevin Liu		 source 1
PHUSE US 2021 VALSPEC Utility to Validate CDISC Specifications [presentation] Aman Bahl,
Hrideep Antony		 source
video		 12
PharmaSUG 2021 Agile Project Management in Analysis and Reporting of Late Stage Clinical Trial Sarad Nepal,
Uday Preetham Palukuru,
Peikun Wu,
Madhusudhan Ginnaram,
Ruchitbhai Patel,
Abhilash Chimbirithy		 source 11
PHUSE EU 2020 A Programmer's Journey Through an Early Oncology Adaptive Platform Trial [presentation] Rafi Rahi source
video		 20
PHUSE EU 2020 Data Collection Time Point - Challenges with Analysis and Submission [presentation] Aayush Bhoraskar,
Sanket Kalyankar		 source
video		 11
PHUSE EU 2020 Data Integrity & Standards in the Clinical Data Pipeline [presentation] Mark Wheeldon,
Raj Indupuri		 source
video		 30
PHUSE EU 2020 Leading Innovation and Change via Olympic Goals [presentation] Robin Koeger,
Ross Farrugia		 source
video		 14
PHUSE EU 2020 Rise and Shine: Using R Shiny to explore insomnia clinical trial data Matthew Brierley source
video
presentation source		 6
PharmaSUG 2020 A Set of VBA Macros to Compare RTF Files in a Batch Jeff Xia,
Shunbing Zhao		 source 6
PHUSE US 2020 Visualizing clinical operational metrics to enable decision-making and accountability Michael Gonzales source
presentation source		 11
PHUSE EU 2019 Finding the Right Balance - Data Management Surveillance in a Fully Outsourced Partnership Model Konstanze Morgenroth source
presentation source		 11
PHUSE EU 2019 Semi Auto-generated Narratives Bjarke Klein source
presentation source		 7
PharmaSUG 2019 Common Pinnacle 21 Report Issues: Shall we Document or Fix? Ajay Gupta source 11
PharmaSUG 2019 Expediting Drug Approval: Real Time Oncology Review Pilot Program Laxmi Samhitha Bontha source 4
PharmaSUG 2019 Strategy to Evaluate the Quality of Clinical Data from CROs Charley Z. Wu source 7
PHUSE US 2019 Interactive Exploratory Analysis and Visualization for Late-phase Clinical Data Sheng-Wei Wang,
Casey Yang		 source
presentation source		 9
PHUSE EU 2018 How to Write ADaM Specifications Like a Ninja Caroline Francis source
poster source		 5
PHUSE US 2018 Infrastructure Designed to Maximize Workflow Paul D. Hamilton source
presentation source		 9
PHUSE US 2018 Secure Data Office: An Independent Team that Can Come to the Rescue in Blinded Trials Annelies Van Zeveren,
Yana Hoorne		 source
presentation source		 9
PharmaSUG 2018 An eSubmission Tracking Tool for both Components and Timelines Todd Case source 5
PharmaSUG 2018 Infrastructure Designed to Maximize Workflow Paul D. Hamilton source 9
PharmaSUG 2018 Preventing premature unblinding in PK/PD related studies Debbie Sisco,
Alice Zong		 source 11
SESUG 2017 Building Heat Maps for Data Cleaning and Beyond Kristen Much,
Nicole Bader		 source 12
SESUG 2017 Statistician's secret weapon: 20 ways of detecting raw data issues Lixiang Larry Liu source 8
PHUSE EU 2017 Clean Patient Tracker - Using Spot Fire Analytics for Patient Data Cleaning Luis Torres source
presentation source		 3
PHUSE EU 2017 SDTM vs CDASH: Why You Need Them Both! [presentation] Kit Howard,
Shannon Labout		 source 20
PHUSE EU 2017 The Secure Data Office Concept Annemie Van Dijck source
presentation source		 9
PHUSE EU 2017 Worst CDISC Implementation Processes - How to Avoid Some Very Basic Mistakes in SDTM ADaM Define Hannes Engberg Reader,
Michale Riech		 source
presentation source		 10
PharmaSUG 2017 Clinical and Vendor Database Harmony; Can-t we all just get along? Brian Armstrong,
Renee Kerwin		 source 9
PharmaSUG 2017 ClinicalTrials.gov Results: an End of Study Deliverable That Should Be Considered at Study Startup Maya Barton,
Elizabeth Paynter		 source 9
PharmaSUG 2017 Data Monitoring Committee Report Programming: Considering a Risk-Based Approach to Quality Control Amber Randall,
Bill Coar		 source 9
PharmaSUG 2017 Don-t Get Lost! A High-efficiency, Low-tech Solution for Navigating Your Department-s Many-Many-Many SOPs and Guidance Documents Michael Hagendoorn,
Tim Yerington		 source 11
PharmaSUG 2017 Statistician's secret weapon: 20 ways of detecting raw data issues Lixiang Larry Liu source 8
PharmaSUG 2017 Takeaways from Integrating Studies Conducted by Bristol-Myers Squibb (BMS) and ONO Yan Wang source 2
PharmaSUG 2017 Woops, I Didn-t Know! An Elegant Solution to Let Your Entire Department Benefit from Individual Lessons Learned Michael Hagendoorn,
Annia Way,
Tim Yerington,
Rachel Bowman		 source 9
PHUSE EU 2016 End-to-end Data and Metadata: It's Not Only a Dream, It's a Reality Gerald Neveu source 6
PHUSE EU 2016 Keeping Track of Database Changes During Database Lock Sanjiv Ramalingam source
presentation source		 6
PHUSE EU 2016 The Hardships of Finding your Way in Biometrics Evi Creebsburg source 4
PharmaSUG 2016 A Practical Approach to Re-sizing Character Variable Lengths for FDA Submission Datasets (both SDTM and ADaM) Xiangchen (Bob) Cui,
Min Chen		 source 19
PharmaSUG CN 2015 Managing the analysis programming effort for an NDA submission Yu Cheng,
Quan Zhou		 8
PharmaSUG 2015 The Dependency Mapper: How to save time on changes post database lock Apoorva Joshi,
Shailendra Phadke		 source 5
PharmaSUG 2014 Clinical Study Report Review: Statistician's Approach Amita Dalvi source 6
PharmaSUG 2014 How Valued is Value Level Metadata? Shelley Dunn source 12
PHUSE EU 2013 An Integrated Platform for Standards Management and Study Conduct - Managing Efficiently your Standards [presentation] Ine Felsenstein,
Jasmine Kestemont		 source 29
PharmaSUG 2012 SDTM Domain Development on the Critical Path - Strategies for Success David C. Izard source 5
PharmaSUG 2010 Quality in a World of "Standards" with Differences! Sandra VanPelt Nguyen 9
PHUSE EU 2009 Clinical Database acceptance: what statistical review checks are necessary to validate a database? Genevieve Jehl source 12
PHUSE EU 2009 Pharmaceutical expectations and CRO expectations - how can we best get them to agree? Karen Turner,
Esther Bayon		 source 9
PharmaSUG 2009 Data Conversion to SDTM: What Sponsors Can Do to Facilitate the Process Fred Wood 6
NESUG 2008 Clinical-Data Acceptance Testing Procedure Sunil Kumar Gupta 15
PharmaSUG 2008 Clinical-Data Acceptance Testing Procedure Sunil Kumar Gupta 15
PharmaSUG 2008 Identifying and Surfacing Data Changes for Effective Quality Management W. Stetson Line,
Scott A. Bahlavooni		 9
SGF 2008 Clinical-Data Acceptance Testing Procedure Sunil Kumar Gupta source 15
PHUSE EU 2007 Electronic record validation Erik Leijskens,
Sini Marant		 source 2
PHUSE EU 2007 LSLV to Final CSR Tables in 24 hours - Dream or Reality? Stinder Fowler source 10
PHUSE EU 2007 PK data file(s) creation process Ann Cuijpers,
Hilde Wuyts		 source 3
PharmaSUG 2006 Identifying the roles and responsibilities of programmers and statisticians in the planning, in-life and post-filing activities for a new drug or vaccine product Margaret James,
Amy Gillespie,
Ying Su,
William Malbecq		 6
PharmaSUG 2002 How are we doing? The importance of metrics and standard practices in clinical data management and biostatistics. Kent Letourneau 6

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