Digital Technology in Clinical Trials
On-Demand Session The Case for a Unified and Integrated eSource and EDC System
- Clinical Data Architect
- SK Data Consulting, Pty Ltd, United States
eSource collection methods have been available for decades with a slow and steady stream of adoption by sponsors, CROs, and Investigator sites. The challenges the industry faced in 2020 forced an increase in the adoption of eSource, and from that, there were many lessons learned. While the FDA defines eSource as any and all electronic source data, Transcelerate Biopharma has determined that eSource is classified in four groups: non-case report form, devices and apps, direct digital entry at the trial site, and patient-sourced EHRs. For the purpose of this presentation, we are focused on direct digital entry at the trial site.
Third-party integrations between investigator site eSource database (eSource) and a Sponsor’s eCRF database (eCRF) are common but often result in costly delays, maintenance, and multiple warehousing. In this presentation, we will discuss how a unified database system of eSource and eCRF can streamline your data collection, accelerate your clinical trial, provide cleaner more accurate data, reduction in errors, and preparation for regulatory submissions.
We’ll provide use case examples from pharma, biotech, and animal health spanning preclinical to Phase IV, and the key factors that contributed to their successful results from using this model. We will cite examples of build timelines being accelerated to under three weeks as opposed to the industry average of twelve, the standardization of data collection, and same-day query resolution. This presentation will underscore the value of real-time data access and analysis with examples of how sponsors and CROs have leveraged this functionality in a unified system. We’ll also discuss how system maintenance and downtime have not impacted productivity due to Medrio’s offline capabilities."
Learning Objective :
- Learn the value and outcomes of a unified data capture system through three use case examples from different industry segments (bio/pharma, animal health, and CRO)
- Recognize the benefits of real-time data, particularly as it relates to queries
- Discover how a unified system allows for a level of data standardization that you cannot achieve with multiple vendors
- Sr. Director, Clinical Data Management and Biostatistics
- Topstone Research, Canada
Preconference Short Courses
Digital Technology in Clinical Trials Resource Kit