The recent political unrest in the Ukraine is a timely example. Often, such major disruptions cannot be specifically predicted, but there should be a contingency plan in place. To minimize the impact of such disruptions, a business continuity plan has to be in place to get the staff, patients and materials in an ongoing study in that region in as safe a position as possible. When managing unanticipated changes, there’s no substitute for experience. A clinical logistics team needs solution-oriented expertise culled from years of hands-on experience in both clinical logistics and clinical trials themselves.
However, expertise alone isn’t enough. These experts must be equipped with tools to adapt to changes in a timely and compliant manner. These tools should include a library of successful lessons learned, IP tracking systems, inventory management and shipment management systems, and a global network of depots prepared to provide full services.
In addition to materials, clinical logistics is also about the people in the system. These contributors range from staff at the investigational site to the clinical team to couriers to depot staff, all entrusted with these important, delicate, and often irreplaceable IMPs. When adjusting to the unexpected, you will have to rely on people adapting, not systems, although a clinical supply chain outsourcing strategy is most effective when tasks and technologies are seamlessly integrated to reduce risk.
Close collaboration with the investigational site is a must. These professionals are the primary partners because they are executing the clinical study and treating patients. It is essential to receive feedback from them on a regular basis to make sure they are content, address areas for improvement and maintain communication throughout any study changes.
From a clinical supply chain perspective, key factors to consider with the investigational site are:
• The geographic location of sites and patients (based on feasibility, recruitment rate and country selection)
• Requirement of ancillary supplies to allow smooth execution of site activities
Close collaboration with the internal clinical team, whether it’s your own team, a sponsor’s team, or a team from another CRO. This team can only complete its timelines when clinical logistics delivers accordingly.
Other important links in the supply chain are shipping partners, including couriers and depot staff, especially when the latter represent third-party depots in other countries. The supply chain moves because of those who take materials from Point A to Point B. These partners must be trained to handle fragile and highly regulated IMPs. They must undergo thorough qualification process and be monitored and audited on an ongoing basis to ensure they are fulfilling the highest industry standards, whether they involve temperature-sensitive storage, which most IMPs need, or regulations of different countries.
Even though every clinical trial is different, they all have one characteristic in common: Every aspect can change and change quickly. Being flexible enough to adapt without risking supply chains and the trials they serve requires a holistic view of the entire process, from operational plans to ancillary supplies to the training of couriers who deliver IMPs. Adopting a holistic view enables one to foresee deviations before they occur and institute strategies to properly react well to those that are unexpected. This can ensure that the right personnel, partners and training are in place to carry out that plan and address those changes. Most importantly, this will create the best opportunity for clinical trial success.