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Wednesday, June 27 • 10:30am - 11:45am
#332: Clinical Data: Let’s Get to the Source and Streamline it to the End

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-18-641-L04-P; CME 1.25; IACET 1.25; RN 1.25

eSource is simply the use of the original source data as collected, without requiring transcription. This session presents successful implementations, case studies, challenges, activities, and best practices by leading industry pioneers.

Learning Objectives

Describe the current source data landscape; Identify integration challenges with eSource data; Identify strategies to influence your organization to adopt eSource methodology.

Chair

Jennifer Price

Speaker

Implementation of Direct Data Capture at Industry-Sponsor Sites
Rakesh Maniar, MS

Implementation of Direct Data Capture at Academic Sites
Michael Buckley

A Case Study of Real-Time Data Capture in eClinical Systems
Randall Paulk

eSource: TransCelerate Perspective and Initiatives
Abhijit Arun Parab, MS


Speakers
MB

Michael Buckley

Manager of Enterprise Innovation, CR Informatics and Technology, Memorial Sloan Kettering Cancer Center
Michael is the Manager of Enterprise Innovation in the Clinical Research Informatics and Technology Division of the Clinical Research Administration. Michael's focus is on technologically innovative projects to improve the efficiency of clinical trials conduct, refine processes to... Read More →
avatar for Rakesh Maniar

Rakesh Maniar

Global Head, Business Technology Services; Co-Lead, TransCelerate eSource Initia, Novartis Pharmaceuticals Corporation
Rakesh is a TransCelerate eSource Workstream Co-Lead and SCDM eSource Implementation Initiative Co-Chair. At Novartis, area of responsibilities includes technology optimization, enable adoption of new technologies & provide value added services for efficient clinical trial execution... Read More →
avatar for Abhijit Parab

Abhijit Parab

Director - CDM and Programming, Allergan
avatar for Randall Paulk

Randall Paulk

Group Leader, Clinical Data Management, Johnson & Johnson Vision Care
Randall is the Manager of Clinical Data Management at Johnson & Johnson Vision. He has over 10 years of experience leading innovation in Clinical Data Management. Prior to joining Johnson & Johnson, Randall was a consultant for Fortune 100 companies providing technical guidance on... Read More →
avatar for Jennifer Price

Jennifer Price

Senior Director, Clinical Data Management, Paidion Research
Jennifer has 25+ years of pharmaceutical industry experience with Biometrics, Data Management and related technologies. Jennifer currently is the head of Data Management for Paidion Research, a Pediatric CRO. In this role, Jennifer is responsible for the collection and management... Read More →

Wednesday June 27, 2018 10:30am - 11:45am
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Data Standards, Session