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Monday, June 24 • 3:30pm - 4:30pm
#159: Understanding the Data Journey In Virtual Trials

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-556-L04-P; CME 1.00; IACET 1.00; RN 1.00

Virtual trials promise to improve clinical research. New methods of data collection and usage also bring new challenges. This forum will model the journey of data in a virtual trial, identify key challenges, and offer solutions for sponsors and CROs.

Learning Objectives

Recognize data collection and usage challenges at all stages of virtual trials; Design successful data practices in a virtual trial.

Chair

Jon Roth, MBA

Speaker

Panelist
Oladele Babalola

Panelist
Robert A. DiCicco, PharmD

FDA Update
Vaishali Popat, MD, MPH

FDA Update
Isaac R. Rodriguez-Chavez, MHS, PhD, MS


Speakers
OB

Oladele Babalola

Associate Director, Data Management, Apellis Pharmaceuticals
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →
avatar for Vaishali Popat

Vaishali Popat

Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Officer, Clinical Research Methodology, Reg Compliance & Medical Policy, CDER, FDA
Dr. Isaac R. Rodriguez-Chavez serves as a FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Past positions in the last 20 years... Read More →
avatar for Jon Roth

Jon Roth

VP, Data Sciences and Biometrics, Biorasi
With over 25 years of clinical trial experience, including a decade as CEO/CTO of a clinical data driven CRO, and a penchant for innovative approaches to clinical study management featuring big data analysis and on-study analytics of live and historical clinical study data, Jon has... Read More →

Monday June 24, 2019 3:30pm - 4:30pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Data Standards, Forum