Best in Stream

Industry

PP18: Bridging the Gap – Enhancing Analysis Results Generation with the CDISC ARS Model and the Community TFL Designer

Bhavin Busa, Clymb Clinical

Collaboration

PP03: SEND (Standard for Exchange of Nonclinical Data) Industry Feedback Survey: 2024 Results

Vanessa Chavez, Labcorp & Lindsy Eickhoff, Inotiv

FDA

PP23: A Framework Enabling LLMS into Regulatory Environment for Transparency and trustworthiness and its Application to Drug Labelling Document

Shraddha Thakkar, FDA

Analytical Risk-based Monitoring

AR01: My Data Is Too Good to Be True! Should I Worry About Fraud or Sloppiness?

Michael Walega, Bristol Myers Squibb & Johann Proeve, Cyntegrity

Analytics & Statistics

AS05: Spline Analysis to Understand the Non-linear Relationship in Clinical Research

Anwaya Joshi, Cytel

Data Handling & Engineering

DH02: Eliminating SDTM Double Programming by Using a Validation Tool and Dummy Data

Glenn Borgmans & Tine Seeuws, SGS Health Science

Data Standards & Governance

DS05: Approaching End-to-End Analysis Standardisation in Global and Therapeutic Areas Level

Rudra Sheth & Xiaohan Zou, Bristol Myers Squibb

Data Visualisation

DV05: Statistical Monitoring Report: A Path Forward to Interactive Data Analysis and Quantitative Decision-Making

Debopriya Ghosh & Xiang Li, Johnson & Johnson

Emerging Trends

ET08: AI Exploration and Innovation for the Clinical Data Scientist

Cole Arendt & Phil Bowsher, Posit

Open Source Technologies

OS03: NEST: How Could We Generate and Deliver Clinical Insights Even Faster?

Vincent Shen, Roche

People Leadership & Management

PM03: Leadership Insights – Let’s Learn How to Lead the Leaders

Rachna Mittal, Genentech

Poster Presentations

PP07: Sowing Seeds of Inspiration: Letters to a Pre-Scientist

Julie Ann Hood, Pinnacle 21 by Certara

Professional Development

PD03: Recruiting the Best Talent and Developing them within the Organisation

Madhusudhan Reddy Papasani & Naveen Kommurur, Merck

Real-world Evidence

RE03: Future Clinical Data Submission Standards: CDISC, FHIR, OMOP, or Hybrid Model

Jeffrey Abolafia, Pinnacle 21 by Certara

Scripts, Macros & Automation

SM10: A Practical Approach to Automating SDTM Using a Metadata-Driven Method that Leverages eCRF Specifications and SDTM Programming Standards

Xiangchen (Bob) Cui & Min Chen, CRISPR Therapeutics

Standards Implementation

SI02: Automating ADaM Creation in Clinical Trials Part 2

Rie Ichihashi & Lyubov Sushchenko, Sanofi

Submissions & Agencies

SA03: Demystifying Submissions to NMPA China

Dyuthi Yellamraju & Hiral Raval, Genentech

Therapeutic Areas Specific Topics

TA04: Are Platform Trials the Need of the Hour for Oncology Trials?

Vidya Muthukumar, IQVIA

Application Development

AD15: Janssen DATA4YOU Platform Approach for Clinical Data Review

Erik Lemmens & Paul Foole, Johnson & Johnson

Analytical Risk-based Monitoring

AR07: Risk-Based Monitoring in Clinical Trials with Machine-Learning-Powered Anomaly Detection

Ece Kavalci & Zaid Al-Jubouri, Lindus Health

Analytics & Statistics

AS10: Comparison of Power Between Different Recurrent Events Analysis Methods Using Simulation

Soumitra Kar, Novo Nordisk

Coding Tips & Tricks

CT05: Dynamic Testing for Empty Datasets

Timothy Lachlan-Cope, AstraZeneca

Connected Health & Machine Learning

CM06: 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, Roche

Data Handling & Data Engineering

DH02: How Can Python Be Used in Clinical Trials?

Pierre Dostie & András Kása, UCB Biosciences

Data Standards & Governance

DS07: Automated Pipelines for Non-CRF Value-Level Metadata: A Meta-Programming Approach

Selena Baset & Philipp Thomas Ernst, Roche

Data Visualisation

DV01: Will R/Shiny Provide a Novel Way for Study Teams to Review Clinical Data?

Gustav Söderström, AstraZeneca

Leadership Through Innovation

LI03: Road to Rome or Roaming – A Reprise

Christian Müller, Roche & Francis Kendall, AstraZeneca

Professional Development

PD05: Mastering the Art of Adaptation: Innovative Strategies for Effective Change Management

Mark Bynens, Johnson & Johnson

People Leadership & Management

PM06: Statistical Programming – Hiring Mission Made Possible

Christoph Ziegler & Donald Paterson, Johnson & Johnson

Poster Presentations

PP16: CDISC’s ADTTE Domain: Time-to-Event Analysis From a Programmer’s Point of View

Vitali Gering & Sophia Praeger, Chrestos Concept

Real-world Evidence

RE06: The Curious Case of Observational Studies – A Programmer’s Dilemma

Vikas Shokeen, Novartis

Submissions & Agencies

SA07: Development Safety Update Report (DSUR)/Periodic Safety Update Report (PSUR)

Phillip Spowart, Fortrea

Software Demonstrations

SD04: Digitalisation of Specifications – Enabling the Next Generation of Clinical Trials

Rebecca Bates & Nekzad Shroff, Saama Technologies

Standards Implementation

SI02: Oak Garden – Metadata-Driven SDTM Automation in R

Magdalena Krochmal & Amy Franklin, Roche

Scripts, Macros & Automation

SM02: Same But Different: Leveraging R for Comparing Clinical Study TFL Versions

Tiina Kirsilä, Novartis & Anna Wiksten, Bristol Myers Squibb