Digital Data Flow Modernize Clinical Trials by enabling a digital workflow

Introduction

The speaker welcomes the audience to the webinar and introduces the Digital Dataflow Initiative. The agenda for the hour-long session is outlined.

Welcome and Orientation

• The speaker welcomes everyone on behalf of Transcelerate.

• An overview of the Digital Dataflow Initiative will be provided by experts.

• Ground rules are established for asking questions during the webinar.

• Topics that cannot be addressed during Q&A are listed.

Logistics

• Participants are muted but can ask questions through a control panel.

• A poll is conducted to gauge participants' understanding of DDF.

• Speakers are introduced, including Bill Ellis, Dave Evans, Bob Hayden, Allison Lachman, and Jacques Bursage.

Foundational Overview

Bill Ellis provides an introduction to Transcelerate and an overview of the Digital Dataflow Project.

About Transcelerate

• Transcelerate is a nonprofit organization founded in 2012 comprised of 20 global biopharma companies that collaborate on key initiatives.

Digital Dataflow Project Overview

• Bill Ellis is the workstream lead for DDF at Transcelerate.

• DDF aims to modernize clinical trials by enabling a digital workflow.

• Details about DDF will be shared throughout the webinar.

Introduction

The speaker introduces the Digital Data Flow (DDF) initiative and its goal of defining industry-wide solutions to reduce fragmentation, eliminate redundant efforts, and solve problems in a more efficient manner.

Primary Goal of DDF Initiative

• The primary goal is working together to define industry-wide solutions.

• Aiming to reduce fragmentation, eliminating redundant efforts and solving the same problems 20 different ways which we often do in our individual companies.

Focus on Innovation and Modernization

• The focus is really on innovation and the modernization of the R&D ecosystem.

• Improving quality, enhancing regulatory compliance, and shifting from managing programs now of related initiatives to leveraging cross-initiative opportunities to accelerate delivery and maximize value.

• Actively discussing and planning around the connections with other initiatives such as Trent Celery, Esource initiative, modernizing clinical trial conduct in real-world data workstreams.

Problem Statement

The speaker discusses the challenges faced by biopharma in adopting digital technologies due to highly manual processes repeated entry of information into different isolated systems leading to long time lags between steps that goes with that systems which frequently have inflexible interfaces.

Challenges Faced by Biopharma

• In clinical development related to systems and exchange of usable data there have been a number of efforts over the years but we continue today to face many challenges and inefficiencies.

• Biopharma lags behind other industries in adoption of digital technologies.

• Highly manual processes repeated entry of information into different isolated systems leading to long time lags between steps that goes with that systems which frequently have inflexible interfaces.

• Systems don't connect with each other only do so with custom-built one-off integrations that are costly to implement and maintain.

• Processes rely on manual steps to interpret and move key information between systems and also to extract and move unstructured data that's often locked up in documents.

Trends Working Against Biopharma

• The rise of digital endpoints, mobile health, digital devices, wearables, internet of things all create new requirements and new ways of running studies.

• Increasing demands to connect with site-based EHR systems and to realize the benefits of e-source data acquisition.

• Starting from a foundation that is not very strong with regard to the ability to capture and use digitized data and also not very strong with regard to exchanging data between systems both within organizations and between organizations.

Digital Transformation Journey

The speaker describes the journey towards effective reuse of study metadata working to drive process automation and provide the foundation for further improvements and innovation.

Digital Transformation Journey

• A well-known document-based unstructured content which defines and specifies the clinical study fragmented processes repeated manual entry of information from a study protocol into multiple other systems leading as I mentioned earlier to long time lags.

• The digital data flow workstream is really part of a journey towards effective reuse of study metadata working to drive process automation.

• Provide the foundation for further improvements and innovation so we very much are on a journey here a digital transformation journey.

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