| PharmaSUG CN |
2024 |
Programming Activities of Conducting Data Masking in Open-Label Study |
Xinyun Gao |
source |
6 |
| PharmaSUG |
2024 |
Agile, Collaborative, Efficient (ACE): A New Perspective on Data Monitoring Committee Data Review Preparation |
Ke Xiao |
source |
6 |
| PharmaSUG |
2024 |
Is a Participation-Level ADaM Dataset a Solution for Submitting Integration Data to FDA? |
Sandra Minjoe |
source |
7 |
| 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 |
| 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 EU |
2022 |
Set Up and Drive Your Routine Business Task with Power Automate [presentation] |
Satish Patil,
Bhavin Solanki |
source
video |
33 |
| PHUSE EU |
2022 |
The Integration Dilemma |
Angelo Tinazzi |
source
video
presentation source |
15 |
| PHUSE EU |
2022 |
The Role of Data Analytics Functions in Studies Utilising RWD for Submissions [presentation] |
Mark Graham,
Ravi Bahia |
source
video |
15 |
| PHUSE US |
2022 |
Real-time Interactive Dashboard for Clinical Trials [presentation] |
Kris Liu |
source |
9 |
| PHUSE EU |
2021 |
Standing Room Only: SA04: Diversity, Equity and Inclusion of Your Submission Package [presentation] |
Anne-Sophie Bekx |
source |
19 |
| PharmaSUG |
2020 |
Using SAS Simulations to determine appropriate Block Size for Subject Randomization Lists |
Kevin Venner,
Jennifer Ross,
Kyle Huber,
Noelle Sassany,
Graham Nicholls |
source |
10 |
| PHUSE US |
2019 |
CDISC in Phase I/II Studies: Case Studies in Adopting Standards |
Emily Woolley,
Amber Randall Scharp |
source
presentation source |
7 |
| PHUSE EU |
2018 |
Practical Benefits of EC: Building a Comprehensive Exposure Story |
Zegher Vereecke,
Donald Benoot |
source
presentation source |
5 |
| WUSS |
2018 |
CDISC in Phase I/II Studies: Approaches to adopting standards for CSR deliverables |
Emily Woolley,
Amber Randall |
source |
9 |
| PHUSE US |
2018 |
Handling Data "Blinding" for Oncology Open Label Studies Using a SAS Macro |
James Zhao |
source
presentation source |
4 |
| PHUSE US |
2018 |
Practical Benefits of EC: Building a Comprehensive Exposure Story |
Donald Benoot,
Zegher Vereecke |
source |
5 |
| PharmaSUG |
2014 |
Considerations in Creating SDTM Trial Design Datasets |
Jerry Salyers,
Richard Lewis,
Kimberly Minkalis,
Fred Wood |
source |
9 |
| PHUSE EU |
2010 |
How to process data from clinical trails and their open label extensions |
Thomas Grupe,
Stephanie Bartsch |
source
presentation source |
5 |
| PHUSE EU |
2010 |
The Ultimate Integration Challenge |
Jennifer Choon-Moi Chin,
Hester Schoeman |
source
presentation source |
11 |
| PharmaSUG |
2010 |
The CDISC/FDA Integrated Data Pilot: A Final Summary of Findings, Reviewer Feedback, and Recommendations Implementing CDISC Standards Within and Across Studies |
Chris Decker |
|
20 |
| PHUSE EU |
2008 |
In at the Deep-End (thoughts on mapping multiple studies into CDISC for an ISS/ISE) |
Andrew Noller |
source |
7 |
| MWSUG |
2008 |
Blinding Sponsors for Open Label Studies: Challenges and Solutions |
Quan Jenny Zhou,
Shengyan Hong,
Zhengping Ma |
|
9 |
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