Navigating GCLP: Best Practices For Regulatory Excellence In Clinical Research

By Donna Aliyetti

As clinical trials become more complex and reliance on outsourced laboratories continues to grow, ensuring the integrity of laboratory data is more important than ever. Good Clinical Laboratory Practice (GCLP) provides a structured framework that blends the ethical principles of Good Clinical Practice (GCP) with the technical rigor of Good Laboratory Practice (GLP), helping to ensure that data from clinical trial sample analysis is accurate, reliable, and reproducible.

For sponsors, CROs, and laboratory teams alike, adopting GCLP standards is key to meeting regulatory expectations and maintaining high-quality outcomes. Core focus areas include training programs, clearly defined roles and responsibilities, SOP development, equipment validation, deviation and CAPA management, and robust specimen tracking systems. Aligning internal processes and those of partner organizations with CAP, CLIA, ISO, and ICH standards further supports operational efficiency and regulatory readiness.

Whether you’re supporting early-stage research or approaching commercialization, mastering GCLP best practices is essential. Learn how to strengthen your laboratory operations and drive regulatory excellence.