Automating Study Setup with a Digital Data Flow

Traditional study setup of eClinical systems requires significant duplication of effort and copying of protocol elements to each system. To accelerate time to market, reduce costs – and ultimately – improve clinical and patient outcomes, leading pharmaceutical organizations are working to change the way that data, analytics, and ecosystem partnerships are used across the entire drug discovery value chain.

Register Free: https://www.pharmexec.com/pe_w/data_flow

Event Overview:

Traditional study setup of eClinical systems requires significant duplication of effort and copying of protocol elements to each system, such as electronic data capture (EDC), randomization (IRT), and trial management (CTMS) solutions. Not only does this result in increased time and effort to study start and setup, but it can also lead in inconsistencies downstream that must be addressed in the data to properly aggregate it for reporting and submission.
To accelerate time to market, reduce costs – and ultimately – improve clinical and patient outcomes, leading pharmaceutical organizations are working to change the way that data, analytics and ecosystem partnerships are used across the entire drug discovery value chain. Data-sharing environments, anchored in up-to-date standards and definitions, play a powerful role in increasing objectivity and decreasing effort.
TransCelerate Biopharma, working with Accenture, began an initiative to develop standards, a reference architecture for a Study Definitions Repository (SDR) with APIs, and supporting materials for implementing a Digital Data Flow (DDF). The goal of the DDF project is to automate study setup by developing the tools and processes to support upstream systems like study builder and protocol authoring tools in defining structured study definitions that can be pushed to the SDR for downstream system consumption and automation.
As vendors participating in the TransCelerate DDF project, Oracle and Nurocor were able to utilize the SDR APIs to automate study setup in Oracle’s Clinical One platform.

Key Learning Objectives:

• The challenges with setting up studies across the eClinical technology landscape
• Toolkits and resources available from TransCelerate to address these challenges and support an optimal digital data flow
• Implementation of a digital data flow from the Nurocor Clinical Platform (NCP) study builder to Oracle Clinical One
• How Oracle and Nurocor were able to automate study setup utilizing the DDF resources, and
• Benefits of automating study setup using the DDF

Who Should Attend:

• Clinical researchers, data scientists, and clinical decision teams responsible for:
  • Clinical development planning, study design, and study planning
  • Clinical data management, collecting and evaluating trial metrics
  • Standards conformant study deliverables
• Project management of studies, process optimization and operational excellence
  

Speakers

ROB SAITER
Managing Director, Life Sciences R&D
Accenture

Rob Saiter is a Managing Director and leads Accenture’s Life Sciences R&D Technology practice. Rob has over 22 years of experience developing and delivering business and technology change programs within Biopharmaceutical R&D organizations, CROs and industry consortia. Rob’s work has focused extensively on clinical development operations, clinical data management and analytics, portfolio management, R&D finance and collaboration amongst development scientists.

FREDERIK MALFAIT
Senior VP of Information Architecture
Nurocor

Frederik is Senior VP of Information Architecture at Nurocor, focused on delivering the Nurocor Clinical Platform for digitalized clinical development. Before that he has consulted for the Biotech/Pharmaceutical industry with assignments ranging across Drug Safety, Biometrics, Clinical Data Management, Statistical Programming, and Data Standards. He has designed a semantic MDR for data standards in a large pharma, initiated the PhUSE CSS Semantic Technology working group and the CDISC Protocol Entities project, consulted for TransCelerate, and led the design and implementation of the initial implementation of the CDISC Library API and Browser.
He holds a Master's Degree in Mathematics.

JULIE SMILEY
Sr. Director, Life Sciences Product Strategy
Oracle

Julie Smiley is Sr. Director of Life Sciences Product Strategy at Oracle. She has over 20 years of experience in the pharmaceutical industry and holds an MS in Computer Information Systems from Boston University. For most of her career, Julie led data management and database programming organizations and as a solution strategist for Oracle Health Sciences, she continues to lead in driving efficiencies across clinical R&D.

Register Free: https://www.pharmexec.com/pe_w/data_flow