Abstract
TransCelerate BioPharma has created the eSource Initiative with the intent to facilitate the industry's movement toward optimal usage of electronic data sources. Although guidance and standards have been in place for some time, data collection methods and technology have not been utilized to their fullest capability, and transcription between electronic systems continues to be the norm. The TransCelerate approach for the eSource Initiative is to understand the current landscape and highlight factors that are influencing the adoption of new technologies. As a preliminary step in this process, TransCelerate surveyed member companies regarding eSource usage and barriers. Literature review, stakeholder engagement, and the member survey have provided insight into the current landscape, which will help TransCelerate to develop proposals for best practices for industry utilization of electronic data collection tools and methods to benefit all stakeholders. Based on survey results, companies generally have taken steps to leverage current eSource technologies and prepare for optimal utilization of electronic data sources. The TransCelerate eSource Initiative will continue to evaluate the technology, regulatory, standards, and health care landscape to support the goal of improving global clinical science and global clinical trial execution. Forthcoming publications will focus on technology landscape, future vision, and demonstration projects.
Highlights
There has been an evolving need endorsed by regulatory agencies to modernize and streamline the way sponsors and other stakeholders collect data in clinical trials.[1]
In order to maximize some of the lessons learned through survey and literature review, feedback was sought from regulatory authorities on the results of this assessment as well as the overall approach of the TransCelerate eSource Initiative
Companies have taken steps to leverage current eSource technologies and prepare for optimal utilization of electronic data sources. It is clear from the feedback from regulators, standards groups, and those TransCelerate members who participated in our eSource survey that there is a common goal to modernize the way we collect and work with data to develop supporting evidence for new drugs.[29]
Summary
There has been an evolving need endorsed by regulatory agencies to modernize and streamline the way sponsors and other stakeholders collect data in clinical trials.[1]. Utilizing eSource can have multiple benefits for stakeholders, including but not limited to the following: reducing unnecessary human intervention with data, increasing data integrity and quality, enabling more rapid identification of safety and operational signals, ensuring data security and privacy, enabling innovative uses of the data, and supporting the stated FDA goal[6] of a fully electronic review environment. Results: Literature review, stakeholder engagement, and the member survey have provided insight into the current landscape, which will help TransCelerate to develop proposals for best practices for industry utilization of electronic data collection tools and methods to benefit all stakeholders. Conclusions: Based on survey results, companies generally have taken steps to leverage current eSource technologies and prepare for optimal utilization of electronic data sources. Forthcoming publications will focus on technology landscape, future vision, and demonstration projects
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