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14 papers and 7 presentations; 20 titles.

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Conference × Year × Title × Authors Extras Pages
PHUSE US 2025 Clearing Up Confusion with Reference Dates Swathi Kotla,
Dana Booth
source
poster source
5
PharmaSUG 2024 Relative Dose Intensity in Oncology Trials: A Discussion of Two Approaches Christiana Hawn,
Dhruv Bansal
source 5
PharmaSUG 2024 Submitting Patient-Reported Outcome Data in Cancer Clinical Trials - Guidance for Industry Technical Specifications Document [presentation] Flora Mulkey source 48
PHUSE EU 2022 Protocol Deviation Programming [presentation] Oussama Zineddine,
Caroline Pelckmans
source
video
25
PHUSE US 2022 'Verify Outputs' Product Demonstration: Validation of Statistical Outputs Using Automation [presentation] Ilan Carmeli,
Yoran Bar
source
video
17
PHUSE US 2022 Table Mining: The Barrier for Automation [presentation] Ilan Carmeli,
Mor Ram-On
source 16
PHUSE US 2022 The Emerging Use of Automation to Address the Challenge of Cross-Table Consistency Checking of Output Used in the Reporting of Clinical Trial Data [presentation] Hugh Donovan,
Naama Feilchenfeld
source
video
16
PHUSE US 2021 Rescreened Subjects, Data Collection and Standard Domain Mapping Savithri Jajam,
Vamshi Matta
source
video
presentation source
6
PHUSE EU 2020 Let's Include Every Data Point: Overview of Analytical Risk-based Monitoring with Spotfire Visualisations [presentation] Raju Tadala source
video
17
PharmaSUG 2019 Multiple Studies BIMO Submission Package - A Programmer's Perspective Ramanjulu Valluru,
Harsha Dyavappa
source 17
PHUSE EU 2018 Robust Test Data Jennie McGuirk,
Ramesh Ayyappath
source
poster source
3
MWSUG 2018 Avoiding Sinkholes: Common Mistakes During ADaM Data Set Implementation Richann J. Watson 15
PharmaSUG 2018 Avoiding Sinkholes: Common Mistakes During ADaM Data Set Implementation Richann J. Watson,
Karl Miller
source 18
PharmaSUG 2018 Preparing the Office of Scientific Investigations (OSI) Requests for Submissions to FDA Zihui Lin,
Wei Cui,
Yaling Teng,
Ran Li
source 9
PharmaSUG 2018 Proactive Role of a Lead Programmer Could Help Prevent Potential Delay in Submission Charan Vem,
Ranjith Kalleda
source 4
PHUSE EU 2017 An FDA Submission Experience Using the CDISC Standards Angelo Tinazzi,
Cédric Marchand
source
presentation source
15
WUSS 2017 Avoiding Sinkholes: Common Mistakes During ADaM Data Set Implementation Richann J. Watson,
Karl Miller
source 15
PharmaSUG CN 2017 Assigning VISITNUM and EPOCH [presentation] Na Duan,
Ru He
32
PharmaSUG 2016 Moving up! - SDTM v3.2 - What is new and how to use it Alyssa M. Wittle,
Christine McNichol,
Antonio Cardozo
source 8
PharmaSUG 2013 Defensive Programming and Error-handling: The Path Less Travelled Tracy Sherman,
Angela S. Ringelberg
source 9
PHUSE EU 2010 Identifying medications that are protocol violations John van Bemmelen source
presentation source
5

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