Ensuring Cold Chain Supplies Maintain Temperature Specifications
The follow-the-patient trend to placing clinical trials in regions with large pools of treatment naïve patients has driven trial locations to an increasing number of countries where the climate is hot, including Latin America. To distribute cold chain IMP to multiple countries within Latin America means juggling a variety of requirements such as import and export rules, local regulatory requirements, varying courier and carrier performance, knowledge of local temperature and transportation variations. This places additional pressure on all parties to the supply chain who must be able to maintain the integrity of supplies within specified strict temperature controls.
Complex cold chain specifications
A leading global pharmaceutical company contacted Fisher Clinical Services with a view to running a multinational clinical trial across many continents including Latin America. The perceived complexity of this multinational clinical trial, with significant volumes of cold chain products being distributed across many continents with different climate zones, prompted Fisher Clinical Services to establish a “review committee” to discuss the proposed study set-up including many aspects of this complex trial – packaging, labeling and distribution.
In this instance the project managers based in Fisher Clinical Services Argentina quickly highlighted the fact that the proposed packaging configuration for the cold chain clinical supplies was not appropriate for the Latin America region. The Sponsor’s packaging vendor had based configurations on Northern Hemisphere climates and temperatures. Immediate action was taken to modify the packaging configurations to include additional gel packs. This new measure would ensure that clinical supplies would maintain specified temperature levels from point of dispatch to delivery to investigator sites.
This rapid intervention by Fisher Clinical Services Argentina delivered significant savings to the Sponsor through excursion avoidance and management of the original drug supply. No replacement IMP was needed for the duration of the trial.
Remote site locations
An additional complication was the remote location of some of the investigator sites in Argentina. Fisher Clinical Services worked closely with the Sponsor to define the best distribution model for the clinical trial supplies, realizing cost and performance efficiencies across the supply chain. Fisher Clinical Services Argentina in partnership with leading freight companies in the region and with local freight companies in more remote locations, ensured the seamless replenishment of clinical supplies to investigator sites. Proactive communication by Fisher Clinical Services to the investigator site staff helped smooth the delivery of cold chain supplies to the sites also accommodating patient appointment schedules. The clinical trial study and the patients were not compromised in any way.
Fisher Clinical Services Argentina continues to support leading global pharmaceutical and biotech companies with the smooth distribution of cold chain clinical supplies across the region.