Presentations

Keynote Presentations:

Secrets of Highly Productive Data Science Team – Micheal Rappa, Institute for Advanced Analytics

Apple iCloud – slide show presentation 

PDF – ( no animated slide builds )

 

Best in stream winners are highlighted in bold.

Analytics, Big Data & Statistics

AB01: Drug-Induced Liver Injury (DILI) Classification Using FDA-Approved Drug Labeling and FAERS Data – FDA  - QAIS HATIM, MINJUN CHEN & MARC STONE 
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AB02: Adverse Event Analysis - One step forward! – ANUJA RASAL - InVentiv Health Clinical
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AB03: Interim Survival Analysis Across 3 Platforms – VENITA DEPUY - Bowden Analytics
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AB04: R or Python: A Programmer's Response – JIANGTANG HU - d-Wise

AB05: A Measurement Error Model Framework for Biomarkers based on Emerging Technologies – DONG WANG - FDA
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AB06:Shaken But Not Stirred: An Example of Subject Classification using Multidimensional Scaling – MANUEL SANDOVAL GARCIA - Bayer
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AB07: Feature Selection for Predictive Modelling – A Needle in a Haystack Problem – IMRAN HOSSAIN, SUDIPTA BASU - Cytel
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ABO8: Machine Learning Driven Clinical Insights – What When & How? –CHANDI KODTHIWADA - Accenture
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WINNER AB09: Modeling and Text Analysis to Empower FAERS Adverse Event Mitigation – QAIS HATIM - FDA. & TOM SABO, EMILY MCRAE - SAS Institute

AB10:Going Pro with PROs: Implementation and Analysis of Patient Reported Outcomes – SHILPAKALA VASUDEVAN - Ephicacy Consulting Group
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AB11: Registry/Observational Studies: Study Designs Data Sources and Key Steps in Designing Such Studies – ANUPAMA SHEORAN - Bayer
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AB12: Statistical Analysis Plan – Clinical Programming Reviewers Guide – XIAOYIN ZHONG, DAN SCHRAMEK - GlaxoSmithKline
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AB13: Augmented Realtime Clinical DataMart – PHANI SHANKAR SRINIVASAN, PONNAPALLI, SUBRAHMANYAM RAYAPROLU - INC Research/inVentiv Health
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AB14: Data Science Applications and Scenarios – EDWIN PONRAJ THANGARAJAN, GIRI BALASUBRAMANIAN - PRA Health Sciences
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AB15: Harnessing Real-time Patient Data to Improve Clinical Outcomes and Research – HIMANSHU PANDYA, CARL DE MOOR, NATE MOCKLER, BOB ENGLE - Biogen
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AB16: Integrating Externally Acquired Data Into Standard Workflows – NATE MOCKLER, SARANYA DURAISAMY - Biogen
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Coding Tips & Tricks

CT01: Fuzzy Joins with Proc SQL for Better Data Utilization – SUNIL GUPTA - Cytel
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CT02: A Practical and Efficient Method of Calculating Actual Time Since Last Dose Data in PK Analysis – YINGQIU YVETTE LIU - PAREXEL
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CT03: How to automate validation with Pinnacle 21 command line interface and SAS – ALEKSEY VINOKUROV - Pinnacle 21
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CT05: How To Derive Parameters At ADaM Level For Generating Yearly Interval Exposure Tables –  GEETHA KESIREDDY - GCE Solutions
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CT06: A Macro Tool to Find and/or Split Variable Text String Greater Than 200 Characters for Regulatory Submission Datasets – VENKATA MADHIRA, HARISH YELUGURI - Shionogi
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WINNER CT07: Controlling the Drawing Space in ODS Graphics by Example – MAX CHERNY - GlaxoSmithKline
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CT08: Convert the Clinical SAS datasets from RTF files – MURALI NEELA - GCE Solutions
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CT09: PROC TEMPLATE and its Application IN TABLES & CROSSTABULATION TABLES – RUCHI SAHU - inVentiv Health Clinical
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CT10: Row Row Row of Zeroes: Their Significance in Summary Tables and Subgroup Analyses – SRIDHAR VIJENDRA, SUMANTH HORABAIL - Ephicacy Lifescience Analytics
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CT11: Alternative Programming Approach for Conditional Processing in SAS - BALRAM CHAUHAN - Cytel
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CT12: Infrastructure Designed to Maximize Workflow – PAUL HAMILTON - Omeros Corporation
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CT13: Upholding Ethics and Integrity: A macro-based approach to detect plagiarism in programming – SRIDHAR VIJENDRA, PRAVEEN KUMAR - Ephicacy Lifescience Analytics
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CT14: Push a Button in Excel to Run all Your SAS Programs – AYLOR MARKWAY - Sarah Cannon Research
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CT15: ANALOG an Interactive Browser-Based and Business-Oriented SAS Log Checker – REZA REZAI - Roche
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CT16: Proc FCMP: Stay Magical – KEERTHANA PALWAI - InVentiv Health Clinical

CT17: Define-XML Value-level Metadata Coding and Naming Guidance – CHARLES SOWERS - IQVI
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Data Handling

DH01: Transformative Re-Emerging Best Practices: Collect Analyze Share – SCOTT BAHLAVOONI, CHRIS DECKER - d-Wise

DH02: Split-Coalesce Tumor Data Handling Woes and Safety-Efficacy Dilemma – IDYA MUTHUKUMAR - Advanced Clinical
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DH03: Cross-study Analysis of SDTM Data Using R - GREG JONES, TODD CORNELIUS - Oracle
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DH04: Missing Data Imputation and Its Effect on the Accuracy of Classification – EDWIN PONRAJ THANGARAJAN, GIRI BALASUBRAMANIAN - PRA Health Sciences
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DH05: Methods for Handling Concentration Values Below the Limit of Quantification in PK Studies – JIM JOHNSON - Summit Analytical
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DH06: Automated Creation of Submission-Ready Artifacts – LOURDES DEVENNEY, SILAS MCKEE - Accenture
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DH07: Secure Data Office: An Independent Team that Can Come to the Rescue in Blinded Trials – ANNELIES VAN ZEVEREN, YANA HOORNE - SGS
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DH08: PDBLoader - Combining Documentation and Code to Create a Pooled Database – DAVID HARTMAN, UCB, MANISHA MADHU - Covance
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DH09: Managing Programs Development Life-Cycles in SAS LSAF – JEAN-MARC FERRAN - Qualiance
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WINNER DH10: Janus Clinical and Nonclinical Loading: The Most Common Issues Identified from Sponsor Submissions – KENDRA WORTHY - FDA


DH11: Practical Solutions when Analyzing Incomplete Disposition Data – SRINIVAS VEERAGONI, JUERGEN LEMBCKE, DAVID WEI - Bayer
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DH12: An Automated Macro to Compare Data Transfers – FRANKLIN MENIUS - Covance
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DH13: Programmers are from Mars and Statisticians are from Venus – SHWETA PADMANABAN, SANGEETHA SATHAIAH - Zifo RnD Solutions
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DH14: Handling Data "Blinding" for Oncology Open Label Studies Using a SAS Macro JAMES ZHAO - Merck
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Data Standards and Governance

WINNER DS01: Comparing and Contrasting Differences between the PhUSE SDSP and CBER Checklist –  JANET LOW, PRITESH SOLANKI - Merck
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DS03: Using a Waiver Process as a Change-Control Tool from ADaM Standards Governance – KARIN LAPANN - Shire
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DS04: SDTM and SEND: An Integrated View and Approach – VEENA NATARAJ - Shire / CHERYL RIEL - Alnylam Pharmaceuticals
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DS05: Keeping Control in a Changing World – JOHANNES ULANDER - S-CUBED
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DS06: Incremental Changes: ADaMIG v1.2 Update – BRIAN HARRIS, MedImmune, TEREK PETERSON - Covance
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DS07: Making PK Analysis Easier: The New ADaM Data Standard ADNCA – PETER SCHAEFER - VCA-Plus
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DS08: Implementing an Metadata Repository Solution - A User Story – BARRIE NELSON -  Nurocor /  WADE FAIRBANKS - Pfizer
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DS09: Business-based Value in an MDR – MANORI TURMEL, KARL KONRAD, BROOKE HINKSON - Merck
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DS10: Generating Define.xml v2.0 and Analysis Result Metadata using ADaM Specifications ADaM Datasets and TFL Shells Annotation – MARK CRANGLE, HIMA BHATIA -ICON
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DS11: Automate Analysis Result Metadata in the Define-XML v2.0 – HONG QI, MAJDOUB HALOUI, LARRY WU - Merck
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DS12: CRF Design for Data Standards – DAVID SCOCCA - Rho
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DS13: Best Practices for Explaining Validation Results in the Study Data Reviewer's Guide – KRISTIN KELLY - Pinnacle 21
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Data Visulatisation

DV01: Clinical Timelines Visualized – SPENCER CHILDRESS, JEREMY WILDFIRE - Rho
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DV02: Mapping Mirena Users in the US JOSE DIAZ, ANTONIO COSTALES, MARIA MAC - Bayer
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DV03: Benefits of a Rapidly Growing Library of  Clinically Relevant Visualization Templates/Patterns – ERIC HERBEL - Integrated Clinical Systems
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DV04: Identification of New Information in a Data Based on a Data Point Level – ERIC KAMMER, BOUBACAR BARRY, THOMAS BINNEN - Bayer
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DV05: R2SAS R2SAS2PDF & SAS2SHINY: Seamless R and SAS – PRAGATHI KOTHA VENKATA, DAREN AUSTIN - GlaxoSmithKline
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WINNER DV06: Subgroup Explorer and AdEPro – The Full Picture on Clinical Trial Data – MADHURIMA MAJUMDER, ERYA HUANG - Bayer
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DV07: A Gentle Introduction to R Graphics from a SAS Programmer's Perspective – NATE MOCKLER - Biogen
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DV08: Unleashing Potential of Graphs for Oncology Trials – MANOJ PANDEY - Ephicacy Consulting Group
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DV09: Supporting a Data Review and Visualization Application with SDTM – DEEPIKA SUNKARA - Covance / JAGADISH DHANRAJ -- MedImmune
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DV10: A Picture is Worth a Thousand Words; Analyzing Clinical Data with Sequencing Data  - NALIN TIKOO - Roche
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DV11: How ODS GRAPHICS INFRASTRUCTURE can be Used in Statistical Analysis – HARIVARDHAN JAMPALA - Covance
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DV12: Web Codebooks – Interactive Data Summaries for Clinical Trial Data - JEREMY WILDFIRE, SPENCER CHILDRESS -  Rho
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DV13: PowerDataExplorer - Data Exploration in an All-In-One Dynamic Report Using SAS & EXCEL –  HARRY CHEN, QIAN ZHAO, LISA LYONS - Janssen Research & Development
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DV14: Data Visualization for Data Monitoring Committees for Clinical Trials – ADAM HAMM - Cytel
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DV15: Insights to Meticulous Clean Patient tracking via Analytics – KISHORE POTHURI, BHAVIN BUSA, SIDDARTHA KONDAPALLY - Vita Data Sciences

DV16: How Automatic Visualization of Summary Results Can Speed up Review to Tables  - SHAFI CHOWDHURY, RAJWANUR RAHMAN - Shafi Consultancy
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DV17: Building Dashboards for Real-time Insights into Clinical Data  BHAVIN BUSA, SIDDARTHA KONDAPALLY - Vita Data Sciences



Poster Presentations

PP01: PhUSE Working Groups - Now & Next – CHRIS PRICE - Roche / SCOTT BAHLAVOONI - d-Wise
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PP02: Define.pdf - Just F.O.P. it – BRIAN MABE - UCB

PP03: Streamline the Collaboration – From Whitepaper Targets (TFL) to Sharable Scripts – HANMING TU,  GUSTAV BERNARD - IQVIA

PP04: Behind the Scenes: From Data to Customized Swimmer Plots Using SAS® Graph Template Language (GTL) – HIMA BHATIA, RITA TSANG- ICON
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PP06: Utilizing Visualizations Developed in R Shiny for Exploratory Safety Analysis - AUSTIN TAYLOR - FDA

PP07: UTF What? A Guide for Handling SAS Transcoding Errors with UTF-8 Encoded Data –  MICHAEL STACKHOUSE - Covance.

PP08: Improving Traceability for Complex Algorithms in ADaM Datasets – PRIYA LAKSHMI SARADHA - Levstat
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PP09: Automating and Customizing TLG Outputs with a Single Click – DEEPAK ANANTHAN, BHARATHY PRASATH - Zifo RnD Solutions 

PP10: Robust Test Data – RAMESH AYYAPPATH, JENNIE MCGUIRK - ICON

PP11: Common Define.xml File Issues Seen During FDA’s JumpStart Service – MARGO COHEN - IBM / PETER GLASS - FDA
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PP12: Post-Marketing Surveillance and the FAERS Big Data Paradox – ADITYA GADIKO - MMS
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PP14: Project Programmer Role – MICHAEL GUNSHENAN, REBECCA GREENWOOD - GlaxoSmithKline
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PP15: Bili's Journey CHRIS HURLEY - MMS / LISA BROOKS - Iris Statistical Computing
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PP16: Planning and Executing a Two-Stage Adaptive Design with Interim Analysis  – KATY JAFFEE - Cytel

PP18: Touchpoints for the Study Data Standardization Plan – KARIN LAPANN - Shire / ELLEN ASAM - Merck
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PP19: Programming Development and Validation Tracking Application – RANDI MCFARLAND, RACHNA MISHRA - ICON
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WINNER PP20: Understanding the Power of Information Modeling for Efficient and Effective Visualization – MICHAEL RUBISON,, STAFFAN GESTRELIUS , EVA KELTY - Capish
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PP21: Qualitative Analysis of Actual SEND Datasets for Trial Design Domains – GEN SATO, Eisai, MUTSUMI SUZUKI, Kyowa Hakko Kirin, KAZUTO WATANABE - Chugai Pharmaceutical
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PP22: Challenges and Opportunities for Real-time Clinical Data Review – RENU SHUKLA  - Janssen Research & Development

PP23: One Vision Five Different Needs: CPE Plan for Standard Analyses and Code Sharing – JARED SLAIN - MPI Research
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PP24: Why Data and Document Anonymization Must Carpool? – RAVI YANDAMURI, RASHMI DODIA - MMS
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PP25: Standard Analyses and Displays for Common Data in Clinical Trials – The Journey Continues! – NHI BEASLEY, FDA, MARY NILSSON - Eli Lilly & Co
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Regulatory

RG01: Achieving Highest Quality and Usability of SEND through Industry and Regulatory Collaboration – WILLIAM HOUSER - Bristol-Myers Squibb / LOU ANN KRAMER -CDISC

RG02: Role of Associate Director of Biomedical Informatics in Clinical Review at the FDA – NHI BEASLEY - FDA

RG03: Confusing Data Validation Rules Explained – MICHAEL BEERS - Pinnacle 21
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RG04: Updates from the EMA  Technical Anonymization Group & Policy 0070 – CATHAL GALLAGHER, CHRIS DECKER - d-Wise
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RG05: Policy 0070 Update: How the Impact of Latest Changes Goes Beyond Biostatistics – CHRIS CONNOR, KEITH WARD - d-Wise

RG06: It's Time To Change –  DAVID IBERSON-HURST - Assero
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RG07: BIMO Listings - Check That Off Your NDA To-Do List –  CHARANJIT KAHLON, DHARMENDRA TIRUMALASETTI, BHAVIN BUSA - Vita Data Sciences

RG08: "What's Rules Got to Do with It?" – HELENA SVIGLIN - FDA
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WINNER RG09: FDA View: Technical Rejection Criteria for Study Data – ETHAN CHEN, LILLIAM ROSARIO - FDA
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RG10: FDALabel Database: Enabling Insights from Product Labelling to Accelerate Advancement of Regulatory S – HONG FANG, JOE MEEHAN. CRYSTAL ALLARD - FDA
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RG11: Use of Real-Time Application for Portable Interactive Device (RAPID) for Data safety and Patient Out –SKIP FRANCIS - FDA

RG12: Assuring Data Integrity and Data Quality in Sponsor Submissions – PAUL SCHUETTE - FDA
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RG13: The Changing Landscape of Data Quality at CDER: an Overview of the Core DataFitness Assessment – CRYSTAL ALLARD, MICHELLE DIETER, FDA, MARGO COHEN - IBM
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RG14: FDA CBER Data Standards Activity Update – LISA LIN - FDA 
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RG15: Biomedical Informatics in the Office of New Drugs CDER/FDA –VAISHALI POPAT - FDA

RG16: CDER’s Clinical Investigator Site Selection Tool – JEAN MULINDE, MICHAEL JOHNSON - FDA
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Standard Implementation

S101: The Untapped Potential of the Protocol Representation Model – JEFF ABOLAFIA - Rho / FRANK DILORIO - CodeCrafters
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SI02: Practical Benefits of EC: Building a Comprehensive Exposure Story – DONALD BENOOT, ZEGHER VEREECKE - SGS

SI03: Automated CRF Annotations – A shift from Manual –SARANGA RAM - Ratilan Technologies

SI04: SDTM: It is Not all Black and White – SWAPNA POTHULA, ROMAN RADELICKI - SGS
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SI05: Qurie - Our own SDTM Bot – DEEPAK ANANTHAN, RAJESH YOVAN, ARVIND SRI KRISHNA MANI - Zifo RnD Solutions
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SI06: Increase Quality and Reduce SDTM Development Time with a Test Study Data Simulator –SASIKUMAR PALANISAMY, BHASKAR SUBRAMANIAN -  Covance
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SI07: Optimizing SDTM Specification Development with Auto-population – CORI KRAMER, RYAN ADALBERT - Covance
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SI08: A Successful Meta-Data Repository (MDR): It's About Managing Relationships – PHILIP GIANGIULIO, MELANIE PAULES - GlaxoSmithKline
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SI09: Commissioning a MDR System: Next-generation of Standards implementation – ABHINAV JAIN - Ephicacy Consulting Group
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SI10: Metadata-based Auto-Programming Process – LISA LYONS, QIAN ZHAO, HARRY CHEN - Janssen Research & Development
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SI11: Using the TFL Workbench for Standards Governance – HANSJÖRG FRENZEL, IAIN HUMPHREYS -  PRA Health Sciences
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SI12: How to Prepare High Quality Metadata for Submission –VARUN DEBBETI - Cytel
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SI13: Step Up Your ADaM Compliance Game –  RAMESH AYYAPPATH, GRAHAM OAKLEY - ICON
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SI14: How to Create your Define.xml as Early as Possible with a Click on a Button – ROMAN RADELICKI, SWAPNA POTHULA - SGS
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WINNER SI15: The First and Last Words of ADaM – SUSAN KENNY - Maximum Likelihood
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SI16: ADaM Intermediate Dataset: How to Improve Your Analysis Traceability – ANGELO TINAZZI, TERESA CURTO, ASHISH AGGARWAL - Cytel
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SI17: Want Submission-Ready Datasets Package from the Get-Go? – KISHORE POTHURI, BHAVIN BUSA - Vita Data Sciences

SI18: Patterns Emerging from Chaos – ALAN CANTRELL - PAREXEL
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SI19: Easing Your Pain with Biomedical Concepts – KIRSTEN LANGENDORF - S-CUBED
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Strategy in Programming

SP02: How do I have ONE Interpretation of CDISC for all my Studies? – MOR MEYEROVICH - Bioforum
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SP03: Ready Set Go:  Planning and Preparing a CDISC Submission – MARIA DALTON - GlaxoSmithKline
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SP04: Moving Cheese: How to Lead Traditional Programmers on the Journey to a New World – MELISSA TANNER, JOHN LEVEILLE - d-Wise / STEVE NOGA - Rho
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SP05: Lead Programmer Needs Help: Dedicated Programming Project Manager to the Rescue! – SMITHA NATHAN, APARNA POONA, BHAVIN BUSA - Vita Data Sciences

SP06: Challenges and Tactics of Managing Clinical Programming in Long Term Outcomes Trials – CEN ZHOU, RAKESH KUMAR, DAVID WADE - GlaxoSmithKline
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WINNER SP07: Mine the Gap: How the Role of Data Scientist Fills a Need in the Pharmaceutical Industry – MICHAEL RIMLER - FMD / JORINE PUTTER - Grünenthal
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SP08: Cue the Word – QC - All You Need to Know! – SUBHA JAMBURAJAN, NANCY HAEUSSER - GlaxoSmithKline
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SP09: SAS Programming is Done by Human Beings – RAY MCKINNIS - PRA Health Sciences
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SP10: A Standardized Collaborative Approach for Statistical Programming Project Information – HARPER FORBES, CHRISTOPH ZIEGLER  - Roche
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SP11: Don't Sweat It! Consider Taking the Risk Out of your Outsourced Deliverables – JENNIFER TRUE, NANCY HAEUSSER - GlaxoSmithKline
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SP12: Introducing Project Management and Emotional Intelligence to Statistical Programmers – WENYUN JI - Amgen
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SP13: Many Minds Make Great Work: Perspectives on Successful Collaborations – SCOTT BAHLAVOONI - d-Wise / CRYSTAL ALLARD - FDA
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SP14: Perfect Your Presentation Pitch: A Presentation on Presentations ZUZANA REHM, JAMES VASQUEZ - GlaxoSmithKline
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Trends & Technologies

TT01: Alexa for Clinical Research – CHRIS DECKER - d-Wise
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WINNER TT02: Why SAS Programmers Should Learn Python Too – MICHAEL STACKHOUSE - Covance
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TT03: Harnessing the Web to Streamline Statistical Programming Processes – DANIEL BOISVERT, PANKAJ KUMAR, GORDON SCHANTZ  - Biogen
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TT04: Upcoming Technology with Transformative Potential for Life Sciences – SAMEER THAPAR - Oracle
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TT05: Postmarket Surveillance Powered by IBM Watson: Assessing Adverse Event Causality – JENO PIZARRO, ANDEEP S. TOOR - IBM

TT06: FDA Experience with Emerging Genomics Technologies – WEIDA TONG - FDA
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TT07: A Semantic NLP Approach for Structuring and Analysis of FDA Meeting Minutes Documents – MICHELLE SHEN, SURESH SUBRAMANI, WEIZHONG ZHAO - FDA

TT08: The Next Generation "Smart Program Repository" – HRIDEEP ANTONY - inVentiv Health Clinical / AMAN BAHL - INC Research/inVentiv Health
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TT09: Generating Table Listings and Figures Without Any Programs – SHAFI CHOWDHURY, MD ZOBAIR - Shafi Consultancy
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TT10: Building Efficient Programming Teams Using RStudio with Git in Pharmaceutical Industry – JAMES KIM - Pfizer
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TT11: Evaluating how Blockchain can Transform the Pharmaceutical and Healthcare Industry –DISA LEE CHOUN, UCB, JIM NASR - Synchrogenix
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TT12: Breaking Away from Shell Scripts for Batch Mode Submissions on SAS GRID –ROBERT DISEKER - Covance
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TT13: A Statistics-based Tool to Inform Risk-based Monitoring Approaches – LAURA WILLIAMS, GIULIA ZARDI, - CROS NT
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TT14: Can Clinical Trial Datasets (CDSIC - SDTM/ADaM) be Generated Using R? – PRASANNA MURUGESAN - AstraZeneca
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TT15: Incorporating Pinnacle 21 with LSAF – SONALI GARG, Alexion Pharmaceuticals, ALEKSEY VINOKUROV - Pinnacle 21 / SANDEEP JUNEJA - SAS
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TT16: Use of HL7 FHIR as eSource to Pre-populate CDASH case Report Forms using a CDISC ODM API – SAM HUME, CDISC, JEFF ABOLAFIA - Rho / GEOFF LOW - Medidata
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TT17: Transforming Clinical Trials with Linked Data – TIM WILLIAMS, UCB, ARMANDO OLIVA - Semantica
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