Success Story: Prelude EDC Enables Compliant Clinical Data Collection for Cornell University’s College of Veterinary Medicine

Background

The Cornell University College of Veterinary Medicine was using a manual system to run their clinical trials, utilizing paper, spreadsheets, and an alternative data capture (EDC) system. The college’s team understood that this manual system made it more time-consuming and burdensome to build studies with edit checks and automation, to manage and analyze data, to share files, and to ensure compliance. They therefore searched for a more efficient and user-friendly EDC system to collect and manage data and support compliance for FDA submissions.

Challenges the Cornell team faced in the old system:

• Restricted access to the EDC platform due to licensing.
• The complex EDC system slowed down implementation, training, and made extracting data in a usable format difficult, discouraging study participation.
• The lack of a robust audit trail caused concerns about the ability to successfully push through submissions to the FDA.
• Volume of study data in files and folders was time-consuming to manage and hindered access.

“Prelude EDC was so easy to use (from training to implementation), and I am not a computer person!”

Clinical Trials and Operations Project Team Manager

Solution

The Cornell University College of Veterinary Medicine switched to Prelude EDC, an easy-to-use electronic data capture system designed to meet regulatory requirements and collect and manage data. Built with the end-user in mind, Prelude provides the college with an intuitive interface and breadth of edit checks and calculations to build out automation. With Prelude EDC, the college’s team is able to streamline their study build and data collection processes and ensure compliance.

Results and benefits of the new system:

• With multi-institutional usage, Prelude EDC enables seamless collaboration for all team members regardless of affiliation.
• Prelude EDC offers a flexible study-building tool, speeding up the process of building studies.
• Its user-friendly, intuitive interface reduces time spent training technical and non-technical investigators.
• Due to data management time savings, investigators are satisfied and more likely to participate in studies.
• Sponsors are also satisfied as they can view study progression, including enrollment and clinical data, in real-time.
• Prelude EDC provides a compliant platform with a robust audit trail, monitoring tools, and signature workflow, leading to participation in more studies and FDA submissions.
• Centralized database for clinical data and documentation ensures easy access for all team members.

“Happy investigators make me happy.”

Clinical Trials and Operations Project Team Manager