NAMSA Guide: How to Design & Develop EDC Systems for Optimal IVD Clinical Trial Management

Electronic Data Capture (EDC) has gained significant traction within the In Vitro Diagnostic (IVD) clinical trial space in recent years. This is partially due to the sheer value derived from the system’s ability to acquire and collate data outputs from complex device technology and software.

However, while the number of clinical trials has steadily increased over the last several years, more than 50 percent of regulated studies are still utilizing paper-based data collection in spite of research showing that EDC platforms can reduce product development timelines and costs by approximately 30-50 percent.

EDC systems provide several benefits to clinical study Sponsors, including a reduction in data collection errors and query management efforts by up to 80 percent. Achieving high data quality and shorter execution times are the primary goals of most clinical trial programs, and implementing the best-fit EDC platform is one of the key steps in achieving successful IVD clinical research outcomes.

NAMSA invites you to access this Guide, “How to Design & Develop EDC Systems for Optimal IVD Clinical Trial Management,” to gain a deeper understanding of:

• EDC Explained
• Features of EDC
• Value of EDC in IVD Clinical Trials
• Identifying the Best-Fit EDC for IVD Clinical Studies
• Understanding Customer Requirements
• NAMSA’s Best Practices for EDC Design
• Case Study: NAMSA’s Clinical Data Management System in Action

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