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protocol deviations

57 papers and 11 presentations; 67 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG 2026 SDTMIG v4.0: Are You Ready For It? Kristin Kelly source 12
PHUSE US 2026 Bridging Patient- and Trial-Level Insights Catharina Dahlbo,
Eva Kelty		 source
poster source		 5
PHUSE US 2026 Building Sustainable RBQM Frameworks: Challenges, Metrics and Real-World Results Nicole Stansbury source
poster source		 7
PHUSE US 2026 Closing the Gap: Identifying Missing Tumour Assessments in Oncology Studies Ke Xiao source
presentation source		 8
PHUSE US 2026 From Oversight to Insight - Rethinking Risk-Based Quality Management Madhumita Ghosh,
Eva Kelty		 source
presentation source		 5
PHUSE US 2026 SDTMIG v4.0: Are You Ready For It? Kristin Kelly source
presentation source		 10
PHUSE APAC 2026 AI-Driven Protocol Review: Accelerating and Simplifying Review Aditya Moogi source
poster source		 14
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 Embracing the Semantic Shift: SDTMIG 4.0 and the Rise of Intelligent Clinical Data Standards Binitha Sathyabhama,
Venkateswarlu Layam		 source
presentation source		 6
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 From Information to Insights: Harnessing Centralized Monitoring in RBQM to proactively identify and mitigate risks in Clinical Trials Bismita Borkakoty,
Priyangshu Chowdhury		 source
presentation source		 12
PHUSE APAC 2026 Innovating Clinical Signal Surveillance: Real-Time Dashboards for Protocol and PK Deviation Monitoring Rubina Pathan,
Jinu J. Nair		 source
poster source		 7
PHUSE EU 2025 Collaborative Industry Open-Source Solutions for Clinical Trial Quality Management Björn Koneswarakantha,
Frederik Collin		 source
presentation source		 9
PHUSE EU 2025 Revolutionising Clinical Trial Monitoring and Data Analysis with AR- and VR-Driven Immersive Analytics Tej Narayan Yadav,
Saurabh Das		 source
presentation source		 7
SESUG 2025 Statistical Programmer's role in Bioresearch Monitoring (BIMO) package creation Sampath Madanu 25
PHUSE US 2025 An Integrated Approach to Protocol Deviation Management Jason Konn source
poster source		 3
PHUSE US 2025 Harnessing the Power of R Shiny in a GxP-Compliant and Validated Manner for Clinical Trial Use Sanyogeeta Andhale,
Shilpa Sood		 source
presentation source		 13
PHUSE US 2025 Key Metrics for Success: Measuring Project Performance and Impact in the Face of Complex Clinical Trials Kavya Yachamaneni,
Hayley MacKenzie		 source
presentation source		 9
PHUSE US 2025 The Olympics of Data Ingestions Cathryn Herbst source
presentation source		 8
PHUSE US 2025 The Right Tool for the Job: Enhancing Risk-Based Monitoring and Data Cleaning Casey Higgins source
presentation source		 4
PHUSE EU 2024 Coral Reef- A FAIR metadata layer to provide clinical study data at your fingertips Javier D. Fernández,
Nelia Lasierra		 source
presentation source		 5
PHUSE EU 2024 Failed Clinical Trials: How to Benefit From Negative Experience Anna Amosova source
presentation source		 13
PHUSE EU 2024 Perl Regular Expressions in SDTM and ADaM Programming: Live Study Examples Pavol Valovic source
presentation source		 7
PharmaSUG CN 2024 Fighting with Special Characters in Data Management Programmer's Daily Work Fei Guo source 20
PharmaSUG 2024 Cultivating Success with Non-standard Investigator-sponsored Trial Data for FDA Submissions Jai Deep Mittapalli,
Jinit Mistry,
Venkatesulu Salla		 source 9
PharmaSUG 2024 Deep Dive into the BIMO (Bioresearch Monitoring) Package Submission Mathura P. Ramanathan,
Nancy Brucken		 source 8
PharmaSUG 2024 Design Considerations for ADaM Protocol Deviations Dataset in Vaccine Studies Rashmi Gundaralahalli Ramesh,
Jeffrey Lavenberg		 source 12
PHUSE EU 2023 Data Managers and R Programming: The Unlikely Pair Anaelle Perretti (Bonetta) source
presentation source		 9
PHUSE EU 2023 Look to the Sky: Introducing COMET - the COncomitant MEdication review Tool Neville Cope source
presentation source		 7
PharmaSUG 2023 BIMO Package: Challenges and Perspectives while keeping up with the upgrades in the BIMO Technical Conformance Guide and the BDRG Guidelines Mathura P. Ramanathan,
Sowmya Gabbula		 source 18
PharmaSUG 2023 Recent updates in BIMO Technical conformance guidance and use case scenario Vaibhav Garg,
Sreedhar Bodepudi		 source 4
PharmaSUG 2023 Using R to Automate Clinical Trial Data Quality Review Melanie Hullings,
Emily Murphy,
Derek Lawrence,
Michelle Cohen,
Andrew Burd		 source 6
PHUSE US 2023 A Programmer's Point of View of Current and Future PD Detection T ools Meng Li source
presentation source		 6
PHUSE EU 2022 Protocol Deviation Programming [presentation] Oussama Zineddine,
Caroline Pelckmans		 source
video		 25
PharmaSUG 2022 Avoid Common Mistakes in Preparing the BIMO Deliverables Chintan Pandya,
Himanshu Patel		 source 9
PHUSE US 2022 RBM - The New Normal Vigilante for CROs With AI and ML [presentation] Vidya Muthukumar source 18
PHUSE EU 2021 New Insights Through Cross-portfolio Risk Analysis [presentation] Abdollahi Rouhollah,
Julian Ortiz		 source
video		 17
PHUSE EU 2021 Standard Implementation: Battling Through the Adversity of a Pandemic [presentation] Ana Arques,
Vicky Poulsen		 source
video		 18
PHUSE EU 2021 Standing Room Only: AR02: The Importance of Being Ernest - The Role of QTLs in QbD [presentation] Andrew Lawton source 19
PHUSE US 2021 COVID-19 Presentation: CO01: Harnessing the Power of Shiny to Visualize Missing Data due to the COVID-19 Pandemic [presentation] Mark Rothe,
Sangeeta Bhattacharya		 source 13
PHUSE US 2021 The Case for Pandemic-disrupted Studies and Challenges Implementing CDISC and FDA COVID-19 Guidelines for NDA Submissions [presentation] Vidya Muthukumar source 44
PHUSE US 2021 Using Central Monitoring to Mitigate Data Quality Risk during the COVID-19 Pandemic [presentation] Adrienne Strickler,
Anna Wojcik		 source
video		 21
PHUSE US 2021 Using Computer Vision to Identify and Extract Tables from Various File Formats [presentation] Kanishk Mair,
Shashank Pagidimarri		 source
video		 22
PHUSE EU 2020 Visualisation of Risk Indicators Using the Shiny App [presentation] Kadriye Kaplan source
video		 10
PharmaSUG 2020 Preparing a Successful BIMO Data Package Elizabeth Li,
Carl Chesbrough,
Inka Leprince		 source 20
PHUSE US 2020 2020 Syneos Health. All rights reserved Working Smarter source 7
PHUSE EU 2019 A Simulation-Based Approach to Establish Quality Tolerance Limits Debbie Adkins source
presentation source		 10
PHUSE EU 2019 Finding the Right Balance - Data Management Surveillance in a Fully Outsourced Partnership Model Konstanze Morgenroth source
presentation source		 11
PharmaSUG 2019 Leveraging Intermediate Data Sets to Achieve ADaM Traceability Yun (Julie) Zhuo source 12
PHUSE US 2019 Using Count-based Statistical Models for Key Performance Indicators, Risk Metrics, etc. [presentation] Aaron Mackey source 15
PHUSE EU 2018 The Importance of Being Ernest - Risk-based Approach (RBA) William Andrew Lawton source
presentation source		 4
WUSS 2018 How sensitive is your analysis? A case study on addressing it at ADaM level. Bhargav Koduru,
Balavenkata Pitchuka		 source 7
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 ODS/RTF Pagination Revisit Ya Huang,
Bryan Callahan		 source 8
SGF 2018 Auto-populating Microsoft PowerPoint Presentations So You Don't Have To Kaitie Lawson source 17
SESUG 2017 Statistician's secret weapon: 20 ways of detecting raw data issues Lixiang Larry Liu source 8
PHUSE EU 2017 The Secure Data Office Concept Annemie Van Dijck source
presentation source		 9
PharmaSUG 2017 Automated DSMB Presentation in SAS: Yeah, I'd Submit That! How to auto populate PowerPoint presentations so you don't have to Brett Jepson,
Kaitie Lawson		 source 17
PharmaSUG 2017 Leveraging Study Data Reviewer-s Guide (SDRG) in Building FDA-s Confidence in Sponsor-s Submitted Datasets Xiangchen (Bob) Cui,
Min Chen,
Letan (Cleo) Lin		 source 10
PharmaSUG 2017 Statistician's secret weapon: 20 ways of detecting raw data issues Lixiang Larry Liu source 8
PharmaSUG 2016 Good versus Better SDTM: Data Listings Mario Widel,
Henry B. Winsor		 source 11
PHUSE EU 2015 ADaM - Our Experience Rob Wartenhorst source
presentation source		 5
PharmaSUG 2014 Let Hash SUMINC Count For You Joseph W. Hinson source 7
NESUG 2013 Use of SAS for Clinical Trial Management and Risk-Based Monitoring of Multicenter Clinical Trial Data from Electronic Data Capture Tools Bob Hall,
David Gagnon		 14
PHUSE EU 2011 Three Unique Case Studies - On the Trail of the Holy Grail of SDTM Implementation Kenneth Stoltzfus source
presentation source		 6
PharmaSUG 2011 Evolution of SDTMIG 3.1.1 to 3.1.2: A mapping specialist must reference on these changes Rachit Desai,
Anirudh Gautam,
Vikash Jain		 source 8
PharmaSUG 2011 Truncation, Variable Association, Controlled Terminology, and Some Other Pitfalls in the SDTM Mapping Process Na Li,
Gary de Jesus,
Daniel Bonzo		 source 8

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