| PharmaSUG CN |
2026 |
ADICE: A Proposed ADaM Dataset Structure for Intercurrent Events in the Estimand Framework |
Lijie Zhu |
source |
11 |
| 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 CN |
2026 |
From SAP to TFL: An AI-Assisted Workflow Framework for Automated Shells and TFLs |
Xiaoyu Ding,
Guoqing Zhao,
Huafeng Gao,
Zhiyuan Guo |
source |
18 |
| PharmaSUG |
2026 |
Structure for Success: Delivering a Complex, Accelerated NDA with Evolving Scope |
Tingting Tian,
Chao Su,
Erica Davis |
source |
4 |
| PHUSE US |
2026 |
Accelerating Study Insights: Agile Data Visualisation Using R-Shiny |
Lin Yuan,
Heather Howell |
source
presentation source |
6 |
| PHUSE US |
2026 |
Advancing Precision Medicine and Regulatory Readiness: Data Harmonisation and Statistical Methods for Companion Diagnostics Bridging Studies |
Ummul Vara Qurratul Ain |
source
presentation source |
10 |
| PHUSE US |
2026 |
End-to-End Workflow for CDISC Estimand Framework in Clinical Trials |
Hiral Raval,
Simon Luo |
source
poster source |
12 |
| PHUSE US |
2026 |
Group, Collapse, Repeat: A Dynamic SAS Macro for Stratification Pooling in Oncology Efficacy Analysis |
Venkatesh Burla |
source
presentation source |
9 |
| PHUSE EU |
2025 |
Statistical Endpoints and Analysis in Diagnostic Imaging: The Matrix Has You and Your Data |
Srinivas Lanka,
James Sykes |
source
presentation source |
17 |
| SESUG |
2025 |
Enhance flexibility and variability by utilizing an Intermediate Dataset when developing the ADaM Efficacy Dataset in Vaccine Studies |
Edward Boykis |
|
6 |
| PharmaSUG |
2025 |
Efficacy Endpoints Related to CNS in Oncology Studies within ADaM |
Lihui Deng,
Kylie Fan |
source |
6 |
| PharmaSUG |
2025 |
Embracing an Extra Step as the Ultimate Shortcut: Leveraging ADDATES for Enhanced Efficiency and Traceability in Oncology Studies |
Chia-Lu Lee,
Wanchian Chen,
Anna Chen |
source |
6 |
| PharmaSUG |
2025 |
Roadmap to Efficacy Analysis for Early Phase Oncology studies |
Dhruv Bansal,
Christiana Hawn,
Chris Kelly |
source |
23 |
| PHUSE EU |
2024 |
Harmonising FDA and PMDA Submission Requirements |
Luca Semeraro |
source
presentation source |
12 |
| SESUG |
2024 |
Streamlining Vaccine Study Output Generation with a Versatile Efficacy Macro |
Zhengyang Shi |
source |
6 |
| PHUSE EU |
2023 |
Efficacy Analyses with Imputations: Methods, Limitations and Lessons Learned |
Amine Khemiri |
source
presentation source |
3 |
| PharmaSUG |
2022 |
A Dynamic Data Visualization Report for Efficacy Endpoints of Early Oncology Study |
Hong (Lily) Zhang,
Yixin Ren,
Huei-Ling Chen |
source |
10 |
| PharmaSUG |
2022 |
SAS ODS Application of Interactive and Informative Clinical Trial Reports |
Luwei Pang,
Aiming Yang |
source |
9 |
| PHUSE US |
2022 |
Practical Challenges in Handling Unstructured Data Using Artificial Intelligence [presentation] |
Farha Feroze |
source
video |
11 |
| PHUSE EU |
2021 |
A Beginner's Guide to Data Analysis |
Shuva Dey |
source
video |
15 |
| PHUSE EU |
2021 |
Preparing PK/PD ADaM Datasets and eCRT Data Package for FDA Submission |
Junying Zhang |
source
video
presentation source |
11 |
| PHUSE EU |
2021 |
PROC MIXED: A Complicated Procedure in Simple Words [presentation] |
Kateryna Fedoryshyna |
source
video |
21 |
| PHUSE US |
2021 |
An SAS Macro for Dynamic Page Breaks [presentation] |
Bhavana Bommisetty,
Manohar Modem |
source
video |
13 |
| PharmaSUG |
2021 |
ADaM-like Dataset: how to do big things in a short time |
Oksana Mykhailova,
Andrii Klekov |
source |
7 |
| PharmaSUG |
2020 |
Analysis Package e-Submission - Planning and Execution |
Abhilash Chimbirithy,
Saigovind Chenna,
Majdoub Haloui |
source |
8 |
| PharmaSUG |
2020 |
r2rtf - an R Package to Produce Rich Text Format (RTF) Tables and Figures |
Siruo Wang,
Keaven Anderson,
Yilong Zhang,
Simiao Ye |
source |
15 |
| PHUSE US |
2020 |
A Programmer's Journey through the BIMO Submission Process |
Raghavender Ranga |
source
presentation source |
12 |
| PharmaSUG |
2019 |
Experiences in Building CDISC Compliant ADaM Dataset to Support Multiple Imputation Analysis for Clinical Trials |
Xiangchen (Bob) Cui |
source |
20 |
| PharmaSUG |
2019 |
Practices in CDISC End-to-End Streamlined Data Processing |
Chengxin Li |
source |
14 |
| PharmaSUG |
2019 |
Useful SAS techniques in Efficacy Analysis for Oncology studies |
Joy Zeng |
source |
21 |
| PHUSE US |
2019 |
Creating the Virologic Response ADaM Dataset |
Manjusha Alapati |
source
presentation source |
7 |
| PHUSE EU |
2018 |
Lessons Learned for Successful e-Study Data Submission to the PMDA towards the End of the Transitional Period |
Takashi Kitahara,
Ayako Noda |
source
presentation source |
12 |
| PHUSE EU |
2018 |
Step-by-step Guide to Efficacy Analysis in Solid Tumors Oncology Clinical Trials |
Anastasiia Tiurdo |
source
presentation source |
11 |
| PharmaSUG |
2018 |
Common Data Related Review Issues and Prevention: A Statistical Reviewer's Thoughts |
Huanyu Chen |
source |
18 |
| PharmaSUG |
2018 |
Implementation of ADaM Basic Data Structure on Genetic Variation Data for Pharmacogenomics Studies |
Linghui Zhang |
source |
10 |
| PharmaSUG |
2018 |
Statistician in my Soul. Statistical Questions from SPA |
Nadiia Hryhorenko |
source |
12 |
| PHUSE EU |
2016 |
Japanese Electronic Submission in CDISC Formats |
Takashi Kitahara |
source
presentation source |
8 |
| PharmaSUG |
2016 |
Good versus Better SDTM: Data Listings |
Mario Widel,
Henry B. Winsor |
source |
11 |
| PharmaSUG |
2016 |
Programming Support for Exposure-Response Analysis in Oncology Drug Development |
Peter Lu,
Hong Yan |
source |
8 |
| PharmaSUG |
2015 |
ADaM Example for a Complex Efficacy Analysis Dataset |
Milan Mangeshkar,
Sandra Minjoe |
source |
8 |
| PharmaSUG |
2015 |
Analysis Methods for a Sequential Parallel Comparison Design (SPCD) |
Harry Haber,
James Zuazo,
Linda LaMoreaux |
source |
11 |
| PharmaSUG CN |
2014 |
Design and Construct Efficacy Analysis Datasets in Later Phase Oncology Study |
Huadan Li,
Changhong Shi |
|
9 |
| PHUSE EU |
2013 |
Maintaining Consistency Between a Substance Database and Single Study Databases |
Dieter Hartz |
source
presentation source |
4 |
| PHUSE EU |
2012 |
Risk-Benefit Analysis for Oncology Clinical Trials |
Lovemore Gakava,
Waseem Jugon |
source
poster source |
8 |
| PHUSE EU |
2012 |
What Makes Oncology Special? |
Johanna Mursic |
source
presentation source |
2 |
| PharmaSUG |
2012 |
A Practice to Create Executable SAS Programs for Regulatory Agency Reviewers |
Hongyu Liu,
Lynn Anderson,
James R. O'Hearn,
Kexi Chen |
source |
6 |
| SGF |
2012 |
Defining the Development Process and Governance of Implementing ADaM within an Organization |
Chris Decker |
source |
11 |
| SGF |
2012 |
Utilize Dummy Datasets in Clinical Statistical Programming |
Amos Shu |
source |
5 |
| PHUSE EU |
2011 |
Defining the Governance and Process of Implementing ADaM across an Organization |
Chris Decker |
source
presentation source |
11 |
| PHUSE EU |
2011 |
Programming for Early and Late Phase - really that different? |
Katherine Macey |
source
presentation source |
6 |
| PharmaSUG |
2011 |
FAQ: Issues with Efficacy Analysis of Clinical Trial Data Using SAS |
Sandeep Sawant,
Nehan Mohan |
source |
5 |
| PharmaSUG |
2010 |
Applying ADaM Principles in Developing a Response Analysis Dataset |
Mei Dey,
Lisa Pyle |
|
8 |
| PharmaSUG |
2010 |
From SAP to ADaM: The Nuts and Bolts |
Nancy Brucken,
Paul K. Slagle |
|
9 |
| PharmaSUG |
2010 |
How to build ADaM from SDTM: A real case study |
Jian Hua (Daniel) Huang |
|
12 |
| PharmaSUG |
2010 |
Tips for Creating Oncologic Efficacy Summary Tables using PROC LIFETEST and PROC PHREG |
Scott Michael Ward |
|
7 |
| NESUG |
2009 |
A Proposed SDTM Implementation of Response Data for Solid Tumor Trials in Oncology |
Mei Dey,
Elisabeth Pyle |
|
18 |
| PharmaSUG |
2009 |
ARROW Clinical Data Analysis System: An Integration of Statistical Analysis and Reporting |
Cheng Jun Tian,
Denis Michel |
|
9 |
| SGF |
2009 |
A Framework to Customize Frame: Building an Interactive Report Web Portal by ODS |
Xin Wei |
source |
10 |
| PharmaSUG |
2005 |
Some Statistical Programming Considerations for e-Submission |
Hang Pang |
|
6 |
| PharmaSUG |
2005 |
The Role of Analysis Datasets in Successful FDA Advisory Meetings |
Sandy Chang |
|
9 |
| WUSS |
2004 |
Successful FDA Advisory Meetings by using Analysis Datasets |
Sandy Chang,
Steven Wong |
source |
10 |
| PharmaSUG |
2000 |
SAS Application for Pharmacokinetic Evaluation and Analysis of the Effect of Treatment with a New Antidepressant Drug in a Population with Major Depression |
Lev Sverdlov,
John F. Noble,
Gabriela Nicolau |
|
8 |
HOME
QUICK SEARCH
AUTHORS
KEYWORDS
HELP
BUGS