Biospecimen Collection and Handling in Clinical Trials: Integrating Nursing, Laboratory, Pharmacy, and Health Security Perspectives

Background: Biospecimen integrity is fundamental to the validity of clinical trial results, yet the complexity of modern protocols requires seamless multidisciplinary coordination. Pre-analytical variables introduced during collection, processing, and handling can compromise specimen quality and research outcomes. Aim: This narrative review synthesizes evidence-based best practices for biospecimen management in clinical trials, examining the integrated roles of nursing, laboratory personnel, pharmacy, and health security professionals in maintaining specimen integrity. Methods: A comprehensive literature search was conducted across PubMed, Scopus, and clinical research databases for peer-reviewed articles published between 2010 and 2024, supplemented by regulatory guidance documents and industry best practice recommendations. Results: Five key determinants of biospecimen quality are identified: (1) standardized collection protocols with comprehensive training; (2) timely pharmacokinetic sampling with coordination between pharmacy and nursing; (3) laboratory processing factors such as cold ischemia time; (4) proper documentation and temperature-controlled logistics; and (5) adherence to evolving regulatory standards like ICH E6(R3). The BEACH trial illustrates effective multidisciplinary integration through continuous research team availability and structured nursing education. Conclusion: Optimal biospecimen management requires systematic integration of multidisciplinary perspectives from protocol design through sample disposition. Institutions must invest in training infrastructure, technology-enabled tracking systems, and risk-based quality management approaches to ensure research validity and regulatory compliance.