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phase ii

123 papers and 47 presentations; 162 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG CN 2026 A Dual-Harness Workflow to Wrap AI into Observable, Reusable Clinical Table Delivery: From SAP Intent to Shell-Aligned Execution Wenjun Zhu source 14
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 Enhancing ADaM Specification Validation and Generation of SAS Codes Using LLM through Amazon Bedrock: A Practical Framework Pavan Kumar Tatikonda,
Ryo Nakaya,
Sravan Kongara		 source 10
PharmaSUG 2026 Structure for Success: Delivering a Complex, Accelerated NDA with Evolving Scope Tingting Tian,
Chao Su,
Erica Davis		 source 4
PHUSE US 2026 Building Cross-Functional Regulatory and Programming Alignment for Successful Submissions Ben Kaspar,
Stephine Keeton		 source
presentation source		 6
PHUSE US 2026 CDISC 360i Demo: Automating from Study Design to Submission Darren Moreland source
presentation source		 6
PHUSE US 2026 Open Source Pavilion: Metadata-driven Automation Interactive [presentation] Orla Doyle,
Rammprasad Ganapathy		 source 28
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 CDISC 360i In Action – Demonstrating the Shift to Fully Digital Standards [presentation] Darren Moreland,
Julie Smiley,
Bhavin Busa,
Peter Van Reusel		 source 11
PHUSE APAC 2026 CDISC 360i – Lessons Learned and Road Ahead [presentation] Peter Van Reusel source 26
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 E2E Clinical Metadata Journey: 'Single Source of Truth' to Accelerate Clinical Research - From Collection and Tabulation to Analysis and Reporting Indumathi Narasetty source
presentation source		 9
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 SAMBA: Bridging the Gap How GenAI Transforms Analysis Plans into ADaM Specs [presentation] Thiago Figueiredo,
Richard Becker		 source 19
PHUSE EU 2025 Showcasing a Shiny Tool for Evaluating Biomarkers for Derisking Clinical Trials Stefan Thoma source
presentation source		 9
PharmaSUG 2025 Application of advanced GenAI tools in sample size estimation - questions and thoughts Igor Goldfarb,
Ella Zelichonok		 source 12
PHUSE US 2025 Enable and Automate: A Technical Roadmap Defining CDISC's Path to End-to-End Automation Samuel Hume source
presentation source		 8
PHUSE EU 2024 Clinical Disease Endpoint Flag Implementation for Vaccine Studies Charumathy Sreeraman source
presentation source		 7
PHUSE EU 2024 Connecting Standard from Design to Analysis to Submission: Finishing the CDISC 360 Vision [presentation] Peter Van Reusel source 25
PHUSE EU 2024 Why Are Old Wines Sometimes Tastier Than New Ones? Lars Andersson,
Henning Pontoppidan Föh		 source
presentation source		 10
PharmaSUG 2024 Agile, Collaborative, Efficient (ACE): A New Perspective on Data Monitoring Committee Data Review Preparation Ke Xiao source 6
PharmaSUG 2024 Generative Artificial Intelligence in sample size estimation - challenges, pitfalls, and conclusions Igor Goldfarb,
Vikas Sharma		 source 26
PharmaSUG 2024 Interfacing with Large-scale Clinical Trials Data: The Database for Aggregate Analysis of ClinicalTrials.gov Joshua J. Cook,
Achraf Cohen		 source 16
PharmaSUG 2024 PHUSE Safety Analytics Working Group - Overview and Deliverables Update Nancy Brucken,
Mary Nilsson,
Greg Ball		 source 5
PharmaSUG 2024 Recruiting Neurodivergent Candidates using the Specialisterne Approach Patrick Grimes source 5
PHUSE US 2024 A Programmer's Perspective on Navigating the Hurdles of Investigator-Sponsored Research (ISR) Trials Jyotsna Lakshmikumar source
presentation source		 6
PHUSE US 2024 Agile, Collaborative, Efficient (ACE): A New Perspective on Data Monitoring Committee Data Review Preparation Ke Xiao,
Hong Wang		 source
poster source		 6
PHUSE EU 2023 Innovating the Leadership Toolkit Through Design Thinking [presentation] Marten Krijgsman,
James McDermott		 source 65
PharmaSUG 2023 PHUSE Safety Analytics Working Group - Overview and Deliverables Update Nancy Brucken,
Clio Wu,
Mary Nilsson,
Greg Ball		 source 5
PharmaSUG 2023 Shifting the drug development paradigm with Adaptive Design and master protocol Aman Bahl source 16
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 CDISC CORE - Milestones, Status and Roadmap Peter Van Reusel source
presentation source		 9
PHUSE US 2023 Handling Multiple Adaptations in One Clinical Trial Parvee Kumar,
Shrutimita Pokhariyal		 source
presentation source		 6
PHUSE US 2023 PHUSE Safety Analytics Working Group - Overview and Summary of Ongoing Projects [poster] Clio Wu,
Mary Nilsson		 source 1
PHUSE EU 2022 Processing Data and Documents with Natural Language Processing and Quantitative Anonymisation Strategies in Support of CTIS Disclosure Requirements [presentation] Elliot Zimmerman,
John Lyons		 source
video		 25
PHUSE EU 2022 R Shiny Apps: To QC or Not to QC? [presentation] Katie Withycombe source
video		 19
PHUSE EU 2022 The Role of Data Analytics Functions in Studies Utilising RWD for Submissions [presentation] Mark Graham,
Ravi Bahia		 source
video		 15
PharmaSUG 2022 Analysis of sample size calculations in clinical trial - errors, pitfalls and conclusions Igor Goldfarb,
Ritu Karwal,
Xiaohua Shu		 source 14
PHUSE EU 2021 Standing Room Only: AR02: The Importance of Being Ernest - The Role of QTLs in QbD [presentation] Andrew Lawton source 19
SESUG 2021 Missing Value Imputation Ross Bettinger source 34
PHUSE US 2021 Automation of a Web-based Metadata Repository for SAS Datasets with Selenium Technology [presentation] Eugene Tsykalov source
video		 14
PharmaSUG 2021 Challenges and Solutions for an ISM Development Si Ru Tang,
Yanhong Li		 source 9
PHUSE EU 2020 A Programmer's Journey Through an Early Oncology Adaptive Platform Trial [presentation] Rafi Rahi source
video		 20
PHUSE EU 2020 Pre-screening Process Flow [poster] Eva Joossens,
Jothi Suresh		 source
video		 1
PHUSE EU 2020 SUPPQUAL Datasets: The Good, the Bad and the Ugly [presentation] Sergiy Sirichenko source
video		 40
PHUSE EU 2020 The TransCelerate Hackathon: Accelerating Development [presentation] Johannes Ulander source
video		 26
SESUG 2020 Analysis and Reporting of Reactogenicity Events in Vaccine Clinical Trials Amarnath Vijayarangan,
Sarah G. Anderson,
Santhiya Poongavanam		 source 9
PHUSE US 2020 Industry Experiences Submitting Standardized Study Data to Regulatory Authorities Janet Low,
Vincent Guo		 source
presentation source		 12
SESUG 2019 Validating Classification and Recidivism in Corrections Through Outcome Analytics Alan R. Mann source 34
PharmaSUG 2019 Jump Start your Oncology knowledge Xiaoyin Zhong,
Feng Liu		 source 9
PharmaSUG 2019 The Anatomy of Clinical Trials Data: A Beginner's Guide Venky Chakravarthy source 14
PHUSE US 2019 Striking a Balance: Adoption of Analysis Results Metadata (ARM) in Early Development Studies Janet Low,
Pranab K. Mitra		 source
presentation source		 6
PHUSE EU 2018 How Do You Determine #SDTMs, ADaMs and TFLs and Their Impact on Outsourcing? Roy Ward source
presentation source		 10
PHUSE US 2018 Comparing and Contrasting Differences between the PHUSE SDSP and CBER Checklist Janet Low,
Pritesh Solanki		 source
presentation source		 5
PHUSE US 2018 Updates from the EMA Technical Anonymization Group & Policy 0070 Cathal Gallagher,
Chris Decker		 source 4
PharmaSUG 2018 Preparing the Office of Scientific Investigations (OSI) Requests for Submissions to FDA Zihui Lin,
Wei Cui,
Yaling Teng,
Ran Li		 source 9
SGF 2018 The Anatomy of Clinical Trials Data: A Beginner's Guide Venky Chakravarthy source 14
PHUSE EU 2017 EMA Policy 0070: Data Utility in Anonymized Clinical Study Reports (CSRs) Jean-Marc Ferran,
Sarah Nevitt		 source 23
PharmaSUG 2017 Awareness from Electronic Data Submission to PMDA and FDA -- Lesson & Learnt from hands-on experiences -- Yuichi Nakajima,
Takashi Kitahara,
Ryan Hara		 source 12
SGF 2017 Kerberos Cross-Realm Authentication: Unraveling the Mysteries Stuart J. Rogers source 18
SGF 2017 Telling the Story of Your Process with Graphical Enhancements of Control Charts Bucky Ransdell source 13
PHUSE EU 2016 Coding WHO-DDE: An Automatic, Easy and Powerful SAS Tool Gianluca Mortari source
presentation source		 11
PHUSE EU 2016 Japanese Electronic Submission in CDISC Formats Takashi Kitahara source
presentation source		 8
MWSUG 2016 Frequentist and Bayesian Interim Analysis in Clinical Trials: Group Sequential Testing and Posterior Predictive Probability Monitoring Using SAS Kechen Zhao 14
PharmaSUG 2016 Delivering a quality CDISC compliant accelerated submission using an outsourced model Mei Dey,
Diane Peers		 source 8
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
SCSUG 2015 Using SAS Software to Determine the Mixed Rotterdam Demand Model Parameters and Test Statistical References Maryam Tabarestani,
Hector Zapata		 23
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 A Web-Based Approach to Fighting Analysis Chaos Gordon Fancher,
Rajeev Karanam,
Shawn Hopkins		 source 7
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 Update: Development of White Papers and Standard Scripts for Analysis and Programming Nancy Brucken,
Michael Carniello,
Mary Nilsson,
Hanming Tu		 source 4
PHUSE EU 2014 A Vision for the Future: Core Competencies for Statisticians and Programmers [presentation] James R. Johnson source 26
PHUSE EU 2014 Creating Standard Analyses and Displays for Common Safety Assessments in Clinical Study Reports Mary Nilsson,
Ann Croft		 source
presentation source		 3
PHUSE EU 2014 Drug Exposure Plot: Tailored Approach to Display Ongoing Data Mathias Lebreton source
presentation source		 12
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
PharmaSUG 2014 Update: Development of White Papers and Standard Scripts for Analysis and Programming Nancy Brucken,
Michael Carniello,
Mary Nilsson,
Hanming Tu		 source 3
PHUSE EU 2013 Orphan Indication Therapies: Programming for a Patient Population without Options [presentation] Todd Case source 24
PHUSE EU 2013 Posch-Bauer Seamless Test with SAS Antonio Nieto,
Javier Gómez		 source
presentation source		 4
PharmaSUG 2013 SAS Programmer to Clinical SAS Programmer Gayatri Karkera,
Nehan Mohan		 source 7
PHUSE EU 2012 Bootstrap simulations to estimate Overall Survival based on the distribution of a historical control Antonio Nieto,
Javier Gómez		 source
presentation 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
SGF 2012 At Your Self-Service: One Organizations Journey from Mainframe Reporting to Enterprise Business Intelligence Cheryl Sivertson source 10
SGF 2012 Graphing Made Easy with SG Procedures Lora D. Delwiche,
Susan J. Slaughter		 source 19
WUSS 2011 Graphing Made Easy with SG Procedures Susan J. Slaughter source 18
PHUSE EU 2011 Programming for Early and Late Phase - really that different? Katherine Macey source
presentation source		 6
SGF 2011 Graphing Made Easy with Output Delivery System (ODS) Graphics Procedures Susan J. Slaughter,
Lora D. Delwiche		 source 18
NESUG 2010 ClinicalTrials.gov: Creating an XML upload from SAS Daniel J. Boisvert,
Andy Illidge,
Troy A. Ruth		 11
WUSS 2010 It's All about Variation: Improving Your Business Process with Statistical Thinking Robert N. Rodriguez source 18
PHUSE EU 2010 A Case Study in Using Unit Testing as a Method of Primary Validation Ross Farrugia source
presentation source		 12
PHUSE EU 2010 AstraZeneca and Quintiles Prgramming Groups - working collaboratively Elizabeth Latta,
Paul Westley		 source
poster source		 8
PHUSE EU 2010 Challenges of Clinical projects shared between Pharma Companies [presentation] Oliver LeConte source 27
PHUSE EU 2010 The Ultimate Integration Challenge Jennifer Choon-Moi Chin,
Hester Schoeman		 source
presentation source		 11
MWSUG 2010 It's All about Variation: Improving Your Business Process with Statistical Thinking Robert N. Rodriguez 18
MWSUG 2010 Using PROC SGPLOT for Quick, High-Quality Graphs Lora D. Delwiche,
Susan J. Slaughter		 20
PharmaSUG 2010 ClinicalTrials.gov: Creating an XML upload from SAS Daniel J. Boisvert,
Andy Illidge,
Troy A. Ruth		 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
SGF 2010 It's All about Variation: Improving Your Business Process with Statistical Thinking Robert N. Rodriguez source 18
SGF 2010 Using Dynamic and Cascading Prompts in SAS Enterprise Guide Kevin Davidson,
Minh Duong		 source 14
SGF 2010 Using PROC SGPLOT for Quick, High-Quality Graphs Susan J. Slaughter,
Lora D. Delwiche		 source 20
SCSUG 2009 Using Dynamic and Cascading Prompts in Enterprise Guide Kevin Davidson,
Minh Duong		 18
PHUSE EU 2009 Clinical Database acceptance: what statistical review checks are necessary to validate a database? Genevieve Jehl source 12
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 Using the ODS Graphics Designer to Create Your Own Template Philip R. Holland source 11
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
WUSS 2009 Using PROC SGPLOT for Quick, High-Quality Graphs Susan J. Slaughter,
Lora D. Delwiche		 source 19
SGF 2009 Best Practice: Optimizing the Cube Build Process in SAS 9.2 Mary Simmons,
Michelle Wilkie		 source 12
SGF 2009 Secrets of the SG Procedures Dan Heath source 19
SGF 2009 Troubleshoot Your Performance Issues: SAS Technical Support Shows You How Michael Williams,
Gretel Easter,
Steve Bradsher		 source 12
PharmaSUG 2008 Experiences Submitting CDISC SDTM and Janus Compliant Datasets Carol Vaughn,
Gregory Ridge,
William Friggle		 10
PharmaSUG 2008 EZTABLE Macros Daniel Huang 12
PHUSE EU 2007 WEB-TRIAGE: Application for patient registration in ph I studies Angelo Tinazzi,
Lucio Ferraresi		 source 10
SGF 2007 Using SAS to Determine Sample Sizes for Traditional Two-Stage and Adaptive Two-Stage Phase II Cancer Clinical Trial Designs St. Clare Groulx,
Adrienne Moon,
Kyung-hee Chung		 source 9
MWSUG 2006 Nonparametric Inference for Ordered Alternatives in a One-Way Layout Using Paul Juneau 15
PharmaSUG 2005 Calculating Posterior Probability of the Maximum Contrast Using PROC IML Akira Wakana,
Isao Yoshimura,
Chikuma Hamada		 6
SCSUG 2004 A SAS/OR Primer on Using PROC LP Michael E. Salassi 14
SUGI 2004 SAS SPM Solution for Healthcare: Quallity Improvement for Providers Using Statistical Process Control Robert N. Rodriguez,
Susan B. Lewellen		 source 28
SESUG 2003 A SAS Macro to Design Phase II Clinical Trials Alan B. Cantor,
Moffitt Cancer		 source 2
SEUGI 2003 Advanced Warehousing & Analytics for the Global Capital Markets [presentation] Bob Giffords source 19
SEUGI 2003 Intelligence at the Heart of Retail [presentation] Chris Dunk source 38
SEUGI 2003 SAS Credit Scoring In-House Scorecard Development Project [presentation] Helena Junqueiro,
Henrik Wagner		 source 40
SEUGI 2003 Using Activity based management analysis to determine and increase profitability in utilities [presentation] Brian Plowman source 39
SUGI 2003 Flip the Bow Tie: Pushing Business Intelligence to Operational Applications Larry D. Bramblett source 6
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
SEUGI 2002 How to benefit from SAS investments over time [presentation] Nicholas Bull source 26
SEUGI 2002 SAS Human Capital Management @ ING Netherlands [presentation] H. Tijssen source 28
SEUGI 2001 Building a Balanced Scorecard in Banca 121 [presentation] Alessandra Turi source 23
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 How to benefit from SAS investments over time [presentation] Nicolas Bull source 26
SEUGI 2001 Servire al meglio ... la migliore clientela [presentation] Giovanni Pietrobelli source 49
SEUGI 2000 AstraZeneca gets a panoramic view of its pharmaceutical business, derived from ERP systems [presentation] Mauro Tuvo source 31
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 How an Operational project benefits from a Business Intelligence project [presentation] Angel Sanz,
Carme Vila,
Josep Turmo,
Ramon Sanchez		 source 19
SEUGI 2000 IBIS-Integrated Business Information System [presentation] Kirsteen MacLeqan source 35
SEUGI 2000 Increase Help-Incident/Desk Efficiency by Using SAS/ITService Vision [presentation] Walter Verhoeven source 23
SEUGI 2000 Nissan European Aftersales: The Move from Legacy System to Data Warehouse [presentation] Jonathan Davies source 35
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 1998 Glasgow City Housing's experience of EIS and SAS software [presentation] Fin McElhinney source 28
SUGI 1998 Application of Maximum Contrast Method to Biomedical Data Using MU L TTEST Chikuma Hamada,
Junji Kishimoto		 source 6
SEUGI 1997 Financial planning and reporting system for the Ministry of Agriculture, Fisheries and Food - a UK Government Department David Fisher source 7
SEUGI 1997 Flexible financial reporting system - development tips using the latest SAS software techniques Andrew B. Ratcliffe,
James Ochiai-Brown		 source 13
SEUGI 1994 Successful IT Strategies within the Government Sector Derek Mather source 14
SUGI 1994 SAS Server: Client/Server Computing Joe Wang source 5
SCSUG 1993 WORK.STAFF -- Using Contract Research Organizations for SAS Programming Ginger Lewis 5
SUGI 1993 SAS/PH-Clinical Software: CANDA Implementation Strategies Juliana M. Ma,
Sandra D. Schlotzhauer		 source 8
SUGI 1990 Integrating Graphics into a Document Using SAS/GRAPH Software and WordPerfect 5.0 Anne C. Neale,
John E. Teberg,
Brian N. Cordova		 source 5
SEUGI 1989 Sample Size For Two-Stage Designs In Phase II Clinical Trials Alfredo Ardia source 6
SUGI 1989 A Clinical Trials Data Management System Featuring Multiple Editing Phases Mark F. Guagliardo,
Kathleen A. Jablonski		 source 5
SUGI 1989 Retro-engineering a SAS Reporting System Front-End Brent Turner source 5
SUGI 1988 Building a Window to a Data Archive, or How to Provide Access to Large Statistical Data Files Tom Boggess source 5
SUGI 1987 An Interface for EPIC and SAS Software James Lichtenstein source 11
SEUGI 1984 SAS Contribution to an Inventory Management System Based on COPICS/DL1 Bernard S. Wuillaume source 3
SUGI 1984 Linear Goal Programming Using the SAS/OR Product Marc-David Cohen source 11
SUGI 1984 Using SAS Software with TSO/SPF to Monitor Network Availability Anita Blitz,
Gail Levine		 source 6
SUGI 1983 Using SAS/GRAPH to Produce Scheduling Charts Mike Atkinson,
Ron Boehm,
Sandy Hemphill		 source 6
SUGI 1981 The Design of a SAS Test Score Management System for Richmond Public Schools Ann S. Allen,
Alvin M. Best III		 source 5

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