THE COMMUNITY ARCHIVE

PHUSE Papers ArchivePage 41

Browse indexed publications from PHUSE. Material labels distinguish papers, presentations, posters and proceedings listings where the source provides them.

3,716 papers · Showing 1601–1640

PHUSE · 2023Paper RM02PHUSE US Connect 2023

Subject: Key Considerations in The QTL Monitoring Tool Design

Jeanine McKenna

Source category: Risk-based Monitoring

PHUSE · 2023Paper SA04PHUSE US Connect 2023

Submission Experience with Real-Time Oncology Review, Project Orbis, and Priority Review

Anna Liu; Sai Ma

Source category: Submissions & Agencies

PHUSE · 2023Paper RE03PHUSE EU Connect 2023

Submission Standards for Real-World Data: Gaps, Limitations and Recommendations

Jeffrey Abolafia; Sarah Ferko

Source category: Real-world Evidence

Author collections: Jeffrey Abolafia · Sarah Ferko

PHUSE · 2023Paper SI08PHUSE EU Connect 2023

Synthesise Your SDTMs! Realistic Simulated SDTMs When You Need Them

Matthew Travell

Source category: Standards Implementation

Author collections: Matthew Travell

PHUSE · 2023Paper ST11PHUSE US Connect 2023

Synthetic Control Arms: Are they the future of Drug Development?

Sherrine Eid

Source category: Beyond Submissions Stories

Author collections: Sherrine Eid

PHUSE · 2023Paper TT16PHUSE EU Connect 2023

Taking Down the Fence Between Biostatistics and Medical Writing

Rob Wartenhorst

Source category: Trends & Technology

Author collections: Rob Wartenhorst

PHUSE · 2023Paper DS08PHUSE US Connect 2023

Technical Rejection Criteria for Study Data (TRC) and Beyond

Lina Cong; Jiang Xu

Source category: Data Standards & Governance

Author collections: Lina Cong · Jiang Xu

PHUSE · 2023Paper TT10PHUSE EU Connect 2023

TFL Automation the CDISC 360 Way

Alison Macnab; John McDade

Source category: Trends & Technology

Author collections: John McDade

PHUSE · 2023Paper SD08PHUSE EU Connect 2023

TFL Designer: Automating Tables, Figures and Listings Design and Generation for Clinical Trial Analysis

Bhavin Busa

Source category: Software Demonstrations

Author collections: Bhavin Busa

PHUSE · 2023Paper RE06PHUSE EU Connect 2023

The Curious Case of Observational Studies – A Programmer’s Dilemma

Vikas Shokeen

Source category: Real-world Evidence

PHUSE · 2023Paper DS03PHUSE EU Connect 2023

The Digital Protocol Is Just the Beginning. Or Is It?

Thierry Philippe; Bill Qubeck

Source category: Data Standards & Governance

Author collections: Thierry Philippe · Bill Qubeck

PHUSE · 2023Paper PD06PHUSE US Connect 2023

The Evolving Role of Project Programmer in The Next 3-5 Years

Vinay Kumar Gupta; Manas Rout

Source category: Professional Development

PHUSE · 2023Paper PP01PHUSE EU Connect 2023

The Evolving Role of Statistical Programmers in the Pharmaceutical Industry: The Impact of Artificial Intelligence

Cindy Marabotti

Source category: Poster Presentations

PHUSE · 2023Paper OS08PHUSE US Connect 2023

The FiguRes Package for Supporting Large Scale Figure Production with Applications to Clinical Trial Reporting Efforts

Greg Cicconetti; David Wade

Source category: Open Source Technologies

Author collections: David Wade

PHUSE · 2023Paper SM10PHUSE EU Connect 2023

The Forgotten Outputs – Data for ClinicalTrials.gov and EudraCT

Erik Brun

Source category: Scripts, Macros & Automation

PHUSE · 2023Paper PP11PHUSE US Connect 2023

The Functional Service Provider Model: A Comprehensive and Collaborative Solution

Dave Polus; Jim Baker

Source category: Poster Presentation

Author collections: Dave Polus · Jim Baker

PHUSE · 2023Paper SM08PHUSE EU Connect 2023

The Hassle of Validating Global SAS Programs: Made Easy(ier)

Michael Hedegaard Thomsen

Source category: Scripts, Macros & Automation

Author collections: Michael Hedegaard Thomsen

PHUSE · 2023Paper CM08PHUSE EU Connect 2023

The Human in the Loop: Accelerating AI/ML Efficiencies for Clinical Data

Achilleas Zaras

Source category: Connected Health & Machine Learning

Author collections: Achilleas Zaras

PHUSE · 2023Paper SA04PHUSE EU Connect 2023

The Journey of Preparing an ISS

Lieke Gijsbers

Source category: Submissions & Agencies

Author collections: Lieke Gijsbers

PHUSE · 2023Paper AD07PHUSE EU Connect 2023

The Open-Source SCE

Caroline Phares

Source category: Application Development

Author collections: Caroline Phares

PHUSE · 2023Paper PP26PHUSE US Connect 2023

The PHUSE Real World Evidence Project

Rabia Ahmad; Berber Snoeijer

Source category: Poster Presentation

Author collections: Rabia Ahmad · Berber Snoeijer

PHUSE · 2023Paper PP06PHUSE EU Connect 2023

The Reality Behind Data Preparation for Statistical Programmers

Megan Carnell; Leon Lombaard

Source category: Poster Presentations

PHUSE · 2023Paper ET01PHUSE US Connect 2023

The Role of AI in Handling Clinical Data and Documents (Structured and Unstructured)

Farha Feroze

Source category: Emerging Trends

Author collections: Farha Feroze

PHUSE · 2023Paper ET09PHUSE US Connect 2023

The Role of AI in the Biometrics and Medical Writing functions

Nalin Gupta

Source category: Emerging Trends

Author collections: Nalin Gupta

PHUSE · 2023Paper RE08PHUSE EU Connect 2023

The Role of FHIR Resources in Ensuring Semantic Equivalence in EHR2EDC Direct Data Capture

Andy Richardson; Patrick Genyn

Source category: Real-world Evidence

Author collections: Andy Richardson · Patrick Genyn

PHUSE · 2023Paper DH09PHUSE US Connect 2023

The Role of Open Source for Data Science, Engineering and Programming Teams in the Pharma Industry

Tadeusz Lewandowski; Axel Muehlig

Source category: Data Handling

Author collections: Tadeusz Lewandowski · Axel Muehlig

PHUSE · 2023Paper PD04PHUSE US Connect 2023

The Rule of Three: Applications in Leadership, Communication, and Strategy

Michael Rimler

Source category: Professional Development

Author collections: Michael Rimler

PHUSE · 2023Paper RM05PHUSE US Connect 2023

The Thick and Thin of Adopting Risk-Based Approach to Data Management

Michal Rucinski; Michal Rucinski

Source category: Risk-based Monitoring

PHUSE · 2023Paper DS02PHUSE EU Connect 2023

The TransCelerate/CDISC Digital Data Flow Project: Practical Electronic Study Designs

Dave Iberson-Hurst

Source category: Data Standards & Governance

Author collections: Dave Iberson-Hurst

PHUSE · 2023Paper SI02PHUSE US Connect 2023

The Ultimate Update to ADaM Specification Template that Simplifies ADaM Programming and Creation of Define XML

YuanYuan Liu; Xiang Wang

Source category: Standards Implementation

Author collections: Yuanyuan Liu · Xiang Wang

PHUSE · 2023Paper OS02PHUSE US Connect 2023

Tidytlg: An R Package for Clinical Reporting using Tidyverse

Sheng-Wei Wang; Eli Miller

Source category: Open Source Technologies

Author collections: Sheng-Wei Wang · Eli Miller

PHUSE · 2023Paper SM12PHUSE EU Connect 2023

Traceability Confirmation at Your Fingertips

Shafi Chowdhury

Source category: Scripts, Macros & Automation

Author collections: Shafi Chowdhury

PHUSE · 2023Paper DH06PHUSE EU Connect 2023

Transparent is the New Black – Improving Data Findability Through Better Clinical Metadata

Lukasz Kniola

Source category: Data Handling & Data Engineering

Author collections: Lukasz Kniola

PHUSE · 2023Paper ET08PHUSE US Connect 2023

Trials Are Out – Pools Are In

Ari Siggaard Knoph

Source category: Emerging Trends

Author collections: Ari Siggaard Knoph

PHUSE · 2023Paper DV04PHUSE US Connect 2023

Unifying RECIST (Tumour Evaluation) Data Review Using the Data Visual Angulation Technique

Mukesh Babu K; Nithiya Ananthakrishnan

Source category: Data Visualization

Author collections: Mukesh Babu K · Nithiya Ananthakrishnan

PHUSE · 2023Paper CM06PHUSE EU Connect 2023

Unleashing the Power of Large Language Models for Clinical Data Approaches: Will AI Chatbots such as ChatGPT/Bard Replace Statistical Programmers and Statisticians Over Time?

Ercan Suekuer

Source category: Connected Health & Machine Learning

Author collections: Ercan Suekuer

PHUSE · 2023Paper SA12PHUSE EU Connect 2023

Unleashing the Role of a Statistical Programmer in Expediting a Submission, Novartis

Sowmya Singuluri

Source category: Submissions & Agencies

Author collections: Sowmya Singuluri

PHUSE · 2023Paper CM09PHUSE EU Connect 2023

Unlock Privacy-Sensitive Data with AI-Generated Synthetic Data

Wim Kees Janssen

Source category: Connected Health & Machine Learning

PHUSE · 2023Paper SS05PHUSE US Connect 2023

Up-to-Date with Dates – Imputation Rules in R Compared to SAS

Monika Ludwinska

Source category: Scripts & Snippets

Author collections: Monika Ludwinska

PHUSE · 2023Paper ST18PHUSE US Connect 2023

Use of R Shiny to Simplify Tracking Data Issues Resolution Progress

Manohar Naidu Vemani; Puli Raju Mandati

Source category: New Tools Stories