10 Expert Recommendations For Smoother EDC Implementations

Clinical trials for small biotechs are often face the challenge of lean teams and high-pressure environments where protocol amendments are not just possible, but inevitable. Navigating Electronic Data Capture (EDC) in this space requires a shift from "big pharma" thinking toward strategies that prioritize agility and data control. Key insights reveal that successful implementations hinge on selecting systems that support seamless mid-study updates and flexible external data integration, such as central lab and imaging results, without requiring a massive IT infrastructure. Furthermore, maintaining ownership over risk-based monitoring rules and ensuring on-demand data access in standardized formats like CDISC ODM can prevent the momentum-killing delays that often plague smaller organizations. By focusing on site usability and integrating patient engagement tools directly into the EDC, biotechs can eliminate data silos and improve overall data quality.