Case Study: Coastal Pediatric Research Achieves 40% Less Regulatory Management Time with Complion

Coastal Pediatric Research - Customer Case Study

Coastal Pediatric Research (CPR), a Charleston-based pediatric research site, was evaluating whether an eRegulatory system would be a worthwhile investment or just a “shiny” IT tool. The team needed a solution that was 21 CFR Part 11 compliant, easy for coordinators and partners to use, flexible enough for different study types, and able to reduce duplicate work while integrating with their CTMS.

CPR implemented Complion’s eRegulatory solution to create a single source of truth for regulatory documents, streamline signatures, support remote monitoring, and improve audit readiness. With Complion, the site standardized workflows, trained coordinators efficiently, and shifted all new studies to electronic management; the results included a 40% reduction in time spent on regulatory document management, signature turnaround improving to within 48 hours, and more time available for recruitment and patient visits.

Coastal Pediatric Research

Julia Brenner

Finance and Regulatory Manager