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Best in Stream

The foundation of PHUSE's events lies in the submitted presentation content. PHUSE have long acknowledged those who contribute exceptional content to drive our event agenda's forward, and this commitment to recognising the best contributors remains steadfast.

PHUSE/FDA CSS 2024

CategoryPoster TitleAuthor(s)View Poster

Industry

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

Bhavin Busa, Clymb Clinical

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Collaboration

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

Vanessa Chavez, Labcorp & Lindsy Eickhoff, Inotiv

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FDA

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

Shraddha Thakkar, FDA

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US Connect 2024

StreamPresentation TitleAuthor(s)View Presentation

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

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Analytics & Statistics

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

Anwaya Joshi, Cytel

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Data Handling & Engineering

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

Glenn Borgmans & Tine Seeuws, SGS Health Science

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Data Standards & Governance

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

Rudra Sheth & Xiaohan Zou, Bristol Myers Squibb

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Data Visualisation

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

Debopriya Ghosh & Xiang Li, Johnson & Johnson

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Emerging Trends

ET08: AI Exploration and Innovation for the Clinical Data Scientist

Cole Arendt & Phil Bowsher, Posit

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Open Source Technologies

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

Vincent Shen, Roche

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People Leadership & Management

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

Rachna Mittal, Genentech

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Poster Presentations

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

Julie Ann Hood, Pinnacle 21 by Certara

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Professional Development

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

Madhusudhan Reddy Papasani & Naveen Kommurur, Merck

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Real-world Evidence

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

Jeffrey Abolafia, Pinnacle 21 by Certara

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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

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Standards Implementation

SI02: Automating ADaM Creation in Clinical Trials Part 2

Rie Ichihashi & Lyubov Sushchenko, Sanofi

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Submissions & Agencies

SA03: Demystifying Submissions to NMPA China

Dyuthi Yellamraju & Hiral Raval, Genentech

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Therapeutic Areas Specific Topics

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

Vidya Muthukumar, IQVIA

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EU Connect 2023

StreamPresentation TitleAuthor(s)View Presentation

Application Development

AD15: Janssen DATA4YOU Platform Approach for Clinical Data Review

Erik Lemmens & Paul Foole, Johnson & Johnson

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Analytical Risk-based Monitoring

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

Ece Kavalci & Zaid Al-Jubouri, Lindus Health

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Analytics & Statistics

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

Soumitra Kar, Novo Nordisk

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Coding Tips & Tricks

CT05: Dynamic Testing for Empty Datasets

Timothy Lachlan-Cope, AstraZeneca

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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

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Data Handling & Data Engineering

DH02: How Can Python Be Used in Clinical Trials?

Pierre Dostie & András Kása, UCB Biosciences

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Data Standards & Governance

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

Selena Baset & Philipp Thomas Ernst, Roche

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Data Visualisation

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

Gustav Söderström, AstraZeneca

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Leadership Through Innovation

LI03: Road to Rome or Roaming – A Reprise

Christian Müller, Roche & Francis Kendall, AstraZeneca

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Professional Development

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

Mark Bynens, Johnson & Johnson

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People Leadership & Management

PM06: Statistical Programming – Hiring Mission Made Possible

Christoph Ziegler & Donald Paterson, Johnson & Johnson

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Poster Presentations

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

Vitali Gering & Sophia Praeger, Chrestos Concept

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Real-world Evidence

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

Vikas Shokeen, Novartis

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Submissions & Agencies

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

Phillip Spowart, Fortrea

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Software Demonstrations

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

Rebecca Bates & Nekzad Shroff, Saama Technologies

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Standards Implementation

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

Magdalena Krochmal & Amy Franklin, Roche

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Scripts, Macros & Automation

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

Tiina Kirsilä, Novartis & Anna Wiksten, Bristol Myers Squibb

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