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phase iii

81 papers and 35 presentations; 115 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG CN 2026 AI-Assisted Code Generation for Structured Table: A Structured Filtering Logic Extraction Approach Qing Ma source 6
PharmaSUG CN 2026 AI-Native Real-Time SDTM Mapping and Exploration Agent Hao Chen,
Xuejie Zhou,
Haomin Yang,
Qianwang Wang		 source 13
PharmaSUG CN 2026 An Integrated, AI-Augmented R Shiny Platform for Oncology Clinical Trial Decision Intelligence: From CDISC Data to Go/No-Go in One Unified Hub Zhiping Yan source 28
PharmaSUG 2026 Early Unblinding to Pharmacometrics (PMx) Data: Challenges, Practices, and Benefits Shweta Vadhavkar,
Jing Su		 source 6
PharmaSUG 2026 Structure for Success: Delivering a Complex, Accelerated NDA with Evolving Scope Tingting Tian,
Chao Su,
Erica Davis		 source 4
PharmaSUG 2026 Tipping Point Analysis: An Illustration of Sensitivity Analysis on Non-Administrative Censoring for Progression-Free Survival (PFS) Lihui Deng,
Kylie Fan,
Xiaoting Qin		 source 7
PHUSE US 2026 From Data Cutoffs to Decision-Making: Programming Futility Analysis in Oncology Clinical Trials Mani Mudumba source
presentation source		 6
PHUSE US 2026 Integrated Summary of Safety (ISS) Demystified: Practical Considerations for a Successful ISS Ji Qi,
Lily Cheng		 source
presentation source		 8
PHUSE US 2026 Prompt Engineering in Gen AI: A Game Changer for the professional development of Statistical Programmers and Data Scientists Kevin Lee source
presentation source		 8
PHUSE US 2026 The Curious Case of External Controlled Arms (ECAs): Practical Solutions for External and RWD Integration Manish Deole,
Preethi Samala		 source
presentation source		 6
PHUSE APAC 2026 "GROWTH GROWS" too – in the professional world! Are we prepared for the change?? Charan Kumar,
Anu Sivanesan		 source
presentation source		 7
PHUSE APAC 2026 Connecting Open-Source and Enterprise Software: Enhancing Phase III Clinical Trial Design Through R Integration in East Horizon Pradip Maske,
Anoop Rawat		 source
presentation source		 6
PHUSE APAC 2026 Crafting a recipe for success : Aligning Target Product Profiles and study design to ensure statistical significance translates to clinical relevance and role of DGF Soumitra Kar,
Novo Nordisk GBS		 source
presentation source		 9
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 EU 2025 Interactive Insights: Leveraging R Shiny for Enhanced Data Visualisation in Clinical Trial Readouts [presentation] Carolyn Fisher,
Elisabeth Deutschmann		 source 20
PHUSE EU 2025 Lets Not Get Lost in Translation: Open-Source Adoption at Novartis Mark Baillie,
Orla Doyle		 source
presentation source		 6
PHUSE EU 2025 Our Journey in Integrating External Control Arms (ECAs) and Real-World Data (RWD) for Rare Disease Trials Cyril Sombrin,
Gautham Selvaraj		 source
poster source		 4
PHUSE EU 2025 Showcasing a Shiny Tool for Evaluating Biomarkers for Derisking Clinical Trials Stefan Thoma source
presentation source		 9
PharmaSUG 2025 AI is coming for you: New Biometric Leadership in the era of Gen AI Kevin Lee source 7
PharmaSUG 2025 Generative AI in Biometrics: Transforming Clinical Trials with Supercharged Efficiency an Innovation Kevin Lee source 6
PharmaSUG 2025 Promising Zone Designs for Sample Size Re-estimation in Clinical Trials: Graphical Approaches Using SAS Zhao Yang,
Shivani Nanda		 source 18
PHUSE US 2025 Revolutionising Clinical Trials: Gen AI-Powered Biometrics Breakthroughs Kevin Lee source
presentation source		 6
PHUSE EU 2024 Clinical Disease Endpoint Flag Implementation for Vaccine Studies Charumathy Sreeraman source
presentation source		 7
PHUSE EU 2024 Optimising Workflow and Collaboration in a Pooled Coding Environment for Clinical Development Louise Noergaard source
presentation source		 8
PHUSE EU 2024 Why Are Old Wines Sometimes Tastier Than New Ones? Lars Andersson,
Henning Pontoppidan Föh		 source
presentation source		 10
PharmaSUG 2024 Interfacing with Large-scale Clinical Trials Data: The Database for Aggregate Analysis of ClinicalTrials.gov Joshua J. Cook,
Achraf Cohen		 source 16
PHUSE US 2024 A Programmer's Perspective on Navigating the Hurdles of Investigator-Sponsored Research (ISR) Trials Jyotsna Lakshmikumar source
presentation source		 6
PHUSE EU 2023 Innovating the Leadership Toolkit Through Design Thinking [presentation] Marten Krijgsman,
James McDermott		 source 65
PHUSE EU 2023 Revolutionising Data Exploration: An Interactive Journey Through R Shiny [presentation] Valentin Legras source 30
PHUSE EU 2023 Slicing Codes: A Modular approach to ADaM programming Mahendran Venkatachalam source
presentation source		 10
PharmaSUG 2023 We Can Work it Out: Dos and Don-ts for Small Biotech and CRO NDA/BLA submission partnership Charity Quick,
Jiaan Illidge		 source 8
PHUSE US 2023 Handling Multiple Adaptations in One Clinical Trial Parvee Kumar,
Shrutimita Pokhariyal		 source
presentation source		 6
PHUSE US 2023 How Python or R Support/Facilitate the Validation Process of TFLs for a Study Development Using Hybrid SAS and R [presentation] Linshan Yuan,
Weiwei Xu		 source 19
PHUSE EU 2022 Technology Disruption in the Last Decade Can Inform Our Future Innovation [presentation] Chris Decker source
video		 19
PHUSE US 2022 Using AI-based Technology to Accelerate Clinical Trial Data Sharing and Reuse [presentation] Ron Kaine,
Thomasin Element		 source
video		 33
PHUSE EU 2021 EMA Panel Discussion: What Might the Future Landscape of Submitting Data Look Like in 2025 ? [presentation] Eftychia-Eirini Psarelli,
Jesper Kjær		 source 14
PHUSE US 2021 Central Statistical False Positives - Predicting True Signals with Machine Learning [presentation] Dorothea Ugi source
video		 24
PharmaSUG 2021 Challenges and Solutions for an ISM Development Si Ru Tang,
Yanhong Li		 source 9
PHUSE EU 2020 Are We on the Same Page - Trial-level Metadata Based Upon Project Metadata [presentation] Bo Sølgaard Andersen,
Frederik Vandvig Heinen		 source
video		 18
PHUSE EU 2020 RBM: Pain or Pleasure? Tips for Effective Implementation [presentation] Steven Thys source
video		 33
PHUSE EU 2020 Rise and Shine: Using R Shiny to explore insomnia clinical trial data Matthew Brierley source
video
presentation source		 6
PHUSE EU 2020 Using R Shiny to Increase the Efficiency of a Study Team [presentation] Emma Moore source
video		 12
PharmaSUG 2020 Data Transformation: Best Practices for When to Transform Your Data Janet E. Stuelpner,
Olivier Bouchard,
Mira Shapiro		 source 4
PHUSE US 2020 Data Science Project (Educating for the Future Working Group) Aldir Medeiros Filho,
Sascha Ahrweiler		 source
presentation source		 10
PHUSE US 2020 Getting e-Closer to Multi-Regional Clinical Trials Lily Ling,
Yuan Yuan Dong,
Yanhong Li		 source
presentation source		 5
PHUSE EU 2019 Lessons Learned from an FDA Real-time Oncology Review Pilot Programme: A Novartis & Roche Perspective Delphine Kerzerho,
Hiren Naygandhi		 source
presentation source		 10
PharmaSUG 2019 The Anatomy of Clinical Trials Data: A Beginner's Guide Venky Chakravarthy source 14
PHUSE EU 2018 How Do You Determine #SDTMs, ADaMs and TFLs and Their Impact on Outsourcing? Roy Ward source
presentation source		 10
SGF 2018 The Anatomy of Clinical Trials Data: A Beginner's Guide Venky Chakravarthy source 14
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 2016 Importance of Niche Provider for Successful NDA Submission: Rescue Case Study Aparna Poona,
Bhavin Busa,
Tim Southwick		 source 9
SGF 2016 Personal Lending: Customer Credit and Pricing Optimization Yuri Medvedev source 19
PHUSE EU 2015 Is R the Right Tool for Me? [presentation] Peter Bewerunge source 23
PHUSE EU 2015 Understanding Trial Design Using Visualisation Maria Benjegard,
Kerstin Forsberg		 source
presentation source		 21
PharmaSUG 2015 CRO, TLF, SOP? OMG!: A Beginner's Guide to the Clinical Research Organization Mandy Bowen,
Otis Evans,
Stephen Terry		 source 7
PharmaSUG 2015 Introducing a Similarity Statistic to Compare Data Libraries for Improving Program Efficiency for Similar Clinical Trials Taylor Markway,
Amanda Johnson		 source 5
PharmaSUG 2015 Utilizing SAS for Cross-Report Verification in a Clinical Trials Setting Daniel Szydlo,
Iraj Mohebalian,
Marla J. Husnik		 source 12
PHUSE EU 2014 A Vision for the Future: Core Competencies for Statisticians and Programmers [presentation] James R. Johnson source 26
PHUSE EU 2014 Submitting Summary Level Site Data: Overview, Implementation and Case Studies Robert F. Woolson,
Jeffrey M. Abolafia,
Ben Vaughn		 source
presentation source		 9
PHUSE EU 2014 Update on Regulatory Guidance: Data Standardisation Planning for Clinical Development Programs James R. Johnson source
presentation source		 10
PHUSE EU 2013 Central Statistical Monitoring in Action Francois Torche,
Erik Doffagne		 source 6
PHUSE EU 2013 Orphan Indication Therapies: Programming for a Patient Population without Options [presentation] Todd Case source 24
PHUSE EU 2013 Patient Cloud and the Future of Clinical Trials [presentation] Christopher Temme source 24
PHUSE EU 2013 Posch-Bauer Seamless Test with SAS Antonio Nieto,
Javier Gómez		 source
presentation source		 4
PHUSE EU 2013 Standard Protocols Using Guided Navigation [presentation] Michaela Jahn source 15
NESUG 2013 Managing Statistical Programmers across the Great Divide: An Odyssey of CRO's, Big and Small Pharma and Biotech, and in NJ, CA and Boston Todd Case 3
PharmaSUG 2013 Experiences in Preparing Summary Level Clinical Site Data within NDA's Submission for FDA's Inspection Planning Xiangchen (Bob) Cui source 19
PharmaSUG 2013 SAS Programmer to Clinical SAS Programmer Gayatri Karkera,
Nehan Mohan		 source 7
SESUG 2012 An Introduction to the Clinical Standards Toolkit Mike Molter source 13
PharmaSUG 2012 An Introduction to the Clinical Standards Toolkit and Clinical Data Compliance Checking Mike Molter source 14
PharmaSUG 2012 Managing Programmers across the Great Divide: An Odyssey in managing CRO-s, in Big and Small Pharma, Biotech and Pharma and in NJ, CA and Boston Todd Case source 3
SGF 2012 At Your Self-Service: One Organizations Journey from Mainframe Reporting to Enterprise Business Intelligence Cheryl Sivertson source 10
PHUSE EU 2011 A Career in the Pharmaceutical Industry James McDermott source
presentation source		 10
PHUSE EU 2011 Programming for Early and Late Phase - really that different? Katherine Macey source
presentation source		 6
PharmaSUG 2011 Creating Forest Plots Using SAS/GRAPH and the Annotate Facility Amanda Tweed source 7
PHUSE EU 2010 AstraZeneca and Quintiles Prgramming Groups - working collaboratively Elizabeth Latta,
Paul Westley		 source
poster source		 8
PHUSE EU 2010 The Ultimate Integration Challenge Jennifer Choon-Moi Chin,
Hester Schoeman		 source
presentation source		 11
PharmaSUG 2010 Using PROC SURVEYMEANS to determine the dispensing time of prescriptions in pharmacies in South Africa: A user's perspective Martie Lubbe,
Faans Steyn		 12
PHUSE EU 2009 An Application of SAS in Model Based Drug Development Imelda Parker,
Michael O'Kelly		 source 4
PHUSE EU 2009 Challenges in running a virtual department through outsourcing Silvana Cappi source 7
PHUSE EU 2009 Does a Sponsor Clinical Trial Reporting System Fit Into a Sponsor/CRO Alliance? Kerry Gordon,
John Salkeld		 source
presentation source		 22
PHUSE EU 2009 Working Effectively in a Globally Dispersed Tea Gary Hearfield source 22
WUSS 2009 Using PROC REPORT to Cross-Tabulate Multiple Response Items Patrick Thornton source 5
MWSUG 2008 Using Direct Standardization SAS Macro for a Valid Comparison in Observational Studies Daojun Mo,
Xia Li,
Alan Zimmermann		 11
PharmaSUG 2008 Experiences Submitting CDISC SDTM and Janus Compliant Datasets Carol Vaughn,
Gregory Ridge,
William Friggle		 10
SGF 2007 Navigating a Major Regulatory Submission Project to Success Alan Meier source 6
PHUSE EU 2006 The Hazards of Modelling Proportional Hazards in SAS Erika Daly,
Farzana Sufi		 source 4
SEUGI 2003 Advanced Warehousing & Analytics for the Global Capital Markets [presentation] Bob Giffords source 19
SEUGI 2003 SAS Credit Scoring In-House Scorecard Development Project [presentation] Helena Junqueiro,
Henrik Wagner		 source 40
SEUGI 2003 Streamlining consolidation process, achieving information transparency [presentation] Sadova source 17
WUSS 2002 A Strategy for Integrating SAS System Results with Microsoft Word Patrick Thornton source 6
SEUGI 2002 Data Mining In A Zero Latency Enterprise Environment [presentation] Luca Selvatici source 24
SUGI 2002 Avoiding Entanglements: Migrating Applications to the Web Eric C. Brinsfield source 5
SUGI 2002 Redesigning Experiments with Polychotomous Logistic Regression: A Power Computation Application Charles M. Vaughan,
Serge Guzy		 source 6
SESUG 2001 Avoiding Entanglements: Migrating Applications to the Web Eric C. Brinsfield source 6
SCSUG 2001 Avoiding OLAP Solutions to the Web Eric C. Brinsfield 6
SEUGI 2001 Building a Balanced Scorecard in Banca 121 [presentation] Alessandra Turi source 23
SEUGI 2001 Data Mining as Method to Streamline the Drug Discovery Process [presentation] Markus Duerring source 20
SEUGI 2001 E-Intelligence and Nokia Online Services [presentation] Rosemarie Ruotto source 19
SEUGI 2001 Electronic Information System (EIS) - Past, Present, Future [presentation] Ruth Brogan source 34
SEUGI 2001 Fast integration of Enterprise Guide and Enterprise Miner with WebHound [presentation] Klaus-Peter Huber,
Rainer Urbahns		 source 12
SEUGI 2001 GIS IP Web: enchancing customer serive via Internet [presentation] Lucien Hofmann,
Torsten Rosenkraenzer		 source 20
SEUGI 2001 Servire al meglio ... la migliore clientela [presentation] Giovanni Pietrobelli source 49
SEUGI 2000 Building a Balanced Scoredard to implement an innovative banking strategy [presentation] Alessandra Turi source 24
SEUGI 2000 CFO Vision and Total Financial Management [presentation] Peter Bull source 34
SEUGI 2000 Data Mining: Churn Management and Client Retention in Telecommunications [presentation] Lori Caton source 20
SEUGI 2000 Deploying Intrnet Server in a European R&D environment [presentation] Klaus-Pieter Vlieg source 13
SEUGI 2000 From Infancy to Maturity: SAS/PH-Clinical Introduction at Fujisawa [presentation] Soren Kristiansen source 40
SEUGI 2000 How an Operational project benefits from a Business Intelligence project [presentation] Angel Sanz,
Carme Vila,
Josep Turmo,
Ramon Sanchez		 source 19
SEUGI 2000 The Growing pains of building a Corporate Data Warehouse [presentation] Tiago Durao source 28
SEUGI 1999 Help! We are building a data warehouse. With a stethoscope on a developing process [presentation] Dag Refvem source 32
MWSUG 1998 Using Embedded HTML in SAS/Intrnet Output Bill Dvorak 5
SEUGI 1997 Development of a resource accounting system Bernadette Ruane source 3
SEUGI 1994 Automatic Generation of Clinical Individual Data Documents, Using Connectively to Access Oracle Data on PC Gaetane Van der Borght source 4
SUGI 1989 A Clinical Trials Data Management System Featuring Multiple Editing Phases Mark F. Guagliardo,
Kathleen A. Jablonski		 source 5
SUGI 1983 Using SAS/GRAPH to Produce Scheduling Charts Mike Atkinson,
Ron Boehm,
Sandy Hemphill		 source 6

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