Given the increased number of global regulatory and standards-based guidance documents issued over recent years, members of the pharmaceutical supply chain are taking notice and making changes to ensure product quality and protect patient safety. Leslie Pérez Ruiz, Daymys Estévez Iglesias and Yoisbel G. Moreno Bermúdez of the Pharmacy Department for Clinical Trials, Center of Molecular Immunology, Havana, Cuba, review the various factors affecting good cold chain management practices for investigational new drugs in clinicaltrials.