Standardization in Clinical Trials: Optimizing Biospecimen Collection, Preservation, and Export

Abstract

Biospecimen standardization has emerged as a critical priority in clinical trials, with the implementation of ICH E6(R3) guidelines in 2025 marking a paradigm shift toward enhanced data integrity and quality management. This comprehensive review examines current best practices, regulatory frameworks, and emerging technologies in biospecimen collection, preservation, and international transport. We explore the impact of pre-analytical variables on sample quality, evaluate international standardization initiatives including ISBER Best Practices and NCI Evidence-Based Practices, and analyze the complex regulatory landscape governing biospecimen export. The integration of artificial intelligence and digital biobanking technologies presents unprecedented opportunities for quality control and sample tracking. This review synthesizes evidence-based recommendations for implementing standardized protocols across the biospecimen lifecycle, from collection through analysis, while addressing practical considerations for multi-site clinical trials. By establishing harmonized practices, the clinical research community can enhance data reliability, facilitate global collaboration, and ultimately improve the translation of research findings into clinical practice.