Sharmin Nasrullah | Vanderbilt Shares Insight on the Site Experience - Register for Summit on Oct 14
Veeva Systems Inc
@VeevaSystems
Published: October 4, 2021
Insights
This video serves as a promotional announcement for a critical panel session scheduled for the upcoming Veeva R&D and Quality Summit. Presented by Sharmin Nasrullah, a Solution Consulting Manager at Veeva, the session focuses on gathering direct insights from clinical sites regarding their operational experience with Electronic Data Capture (EDC) systems, specifically Veeva Vault EDC. The primary goal of the panel is to illuminate how technology impacts the daily workflow of clinical research professionals and how platforms like Vault EDC can simplify complex processes.
The central theme revolves around optimizing the "Site Experience" within clinical trials. The panel, featuring representatives from Vanderbilt, aims to provide practical advice and real-world feedback on critical components such as Case Report Forms (CRFs) and the overall usability of the Vault EDC platform. By focusing on the site perspective, the session addresses the significant industry challenge of reducing administrative burden and improving data quality at the source. This approach underscores the importance of user-centric design in regulated enterprise software, ensuring that systems facilitate, rather than hinder, the rapid and accurate execution of clinical protocols.
The discussion is structured to cover the entire spectrum of study management, from initial startup procedures through ongoing study execution. This comprehensive scope suggests that the panelists will delve into how Vault EDC streamlines the often-laborious process of site initiation, data entry, query resolution, and overall study management. For technology providers and consultants in the life sciences space, understanding these site-level pain points—particularly concerning CRFs and EDC usability—is essential for developing effective integration strategies and AI-powered tools that enhance clinical operations efficiency and compliance.
Key Takeaways:
• The "Site Experience" is a primary focus area for technology optimization in clinical trials, suggesting that adoption rates and data quality are highly dependent on the ease-of-use and intuitive design of EDC systems like Veeva Vault EDC.
• Direct feedback from major clinical institutions, such as Vanderbilt, offers invaluable, real-world data on the performance and integration challenges associated with regulated software platforms, which is crucial for custom software development and consulting firms.
• The panel specifically addresses Case Report Forms (CRFs), highlighting that the design and digital implementation of these forms remain a critical bottleneck or point of optimization for data capture accuracy and site efficiency.
• Veeva Vault EDC is positioned as a key solution for simplifying both study startup and ongoing study execution, indicating that the platform offers features designed to accelerate site activation and streamline data management workflows.
• The emphasis on hearing "directly from our clinical sites" signals a growing industry trend toward prioritizing the end-user perspective (nurses, coordinators, investigators) when evaluating and implementing clinical technology, moving away from purely sponsor-centric solutions.
• For firms specializing in data engineering and business intelligence, the insights gathered from site experience panels can inform the design of robust data pipelines that account for common data entry errors or workflow inefficiencies identified by users.
• The R&D and Quality Summit serves as a vital venue for tracking the evolving landscape of clinical technology, regulatory compliance integration (R&D and Quality often overlap in Veeva Vault), and the adoption of enterprise-grade software within the pharmaceutical sector.
• Improving the site experience through technology directly impacts the speed and cost of clinical trials; therefore, solutions that leverage AI or automation to further simplify data entry or query management within the EDC environment are highly valuable.
Tools/Resources Mentioned:
- Veeva Vault EDC (Electronic Data Capture)
- Veeva R&D and Quality Summit
Key Concepts:
- Site Experience: Refers to the overall ease-of-use, efficiency, and satisfaction clinical site personnel (coordinators, investigators) have when interacting with the technology and processes required to conduct a clinical trial. Optimizing this experience is key to reducing site burden and improving data quality.
- CRFs (Case Report Forms): Standardized documents or electronic forms used to collect data on each trial participant as required by the study protocol. The design and usability of CRFs are fundamental to accurate data capture.
- Vault EDC: Veeva's cloud-based Electronic Data Capture system, used by pharmaceutical companies and CROs to manage clinical trial data collection and cleaning.