The Challenge Today: High Cost for Low Data Quality
Today, 90% of sites in EDC studies still create study-specific paper source forms, spending approximately three days on this effort per study. Once the study is running, site coordinators are over-burdened by the sheer volume of data to transcribe into EDC, which can take over an hour per patient per visit and is typically not entered in EDC until two to three weeks after the patient visit1.
In addition to these delays in reviewing the data, study teams then face massive query volumes. The biggest cost of all, Source Data Verification (SDV) and associated on-site monitoring, can reach millions of dollars in large Phase III studies.
The Current State: Low eSource Adoption
eSource addresses many of these challenges by eliminating the paper source and providing faster access to higher quality data. Yet, despite the industry’s best efforts, eSource adoption is low, only used in a handful of studies.
Causes for this low eSource adoption range from cost to change management, regulatory compliance concerns, and technology barriers. Yet the biggest obstacle stems from the need to still run EDC as well as eSource in many studies.
In such cases, for a scalable solution, organizations are typically having to contract with a leading EDC vendor and then separately with a leading eSource vendor. This immediately doubles study team workload and erodes the benefits: managing two vendors, two designs, two builds and systems to integrate and manage the data within.
The Solution: eSource & EDC Combined
With eSource and EDC combined in a modern cloud platform, study teams can design and build once, while the same data becomes immediately accessible across the platform for instant review and decision-making.
Modern EDC and eSource enables study builds in days, not weeks, without the need for programming, and sites can customize electronic source forms to suit their workflow. Intuitive eSource form designs and guidance can dramatically reduce queries and on-site monitoring, while driving greater compliance.
Join Veeva to learn how a combined EDC and eSource solution improves the quality of clinical data and reduces the time to actionable insights. In this webinar, we will cover:
- The industry vision for clinical data collection and management
- Why we need EDC and eSource combined
- How technological innovation has accelerated study builds from weeks to days
- Critical success factors when eliminating paper source data collection at sites
1Why is Clinical Source Data Still Collected on Paper? SCRS, May 2017
Richard Young, VP, Vault EDC, Veeva
As vice president for Veeva Vault EDC, Richard is responsible for establishing Veeva Vault EDC as the best in class solution for all data acquisition, management and reporting purposes. With almost 25 years of experience in life sciences, Richard is known for his executive vision and proven operational experience in data management, eClinical solutions, and advanced clinical strategies.
Hugo Cervantes, VP, Vault EDC, Veeva
As vice president Vault EDC, Hugo is responsible for Vault EDC strategy, market adoption, and customer engagement. Hugo has spent the last 15 years in management consulting and professional services, helping biopharmaceutical organizations increase their productivity, innovate and grow.
Veeva is a leader in cloud-based software for the global life sciences industry. Veeva Vault Clinical Suite is the industry’s first cloud platform that combines EDC, eSource, CTMS, eTMF, study start-up, and site document exchange to unify clinical data management and clinical operations. Veeva’s suite of clinical applications is built on the Veeva Vault Platform, the only content management platform with the unique capability to manage both content and data, eliminating system silos, and streamlining end-to-end clinical trial processes.
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