Complexity in supply management
During previous clinical trials of equivalent scope, the sponsor faced several logistical hurdles that affected clinical trial supply. Sites were overwhelmed by the task of splitting bulk supplies and managing shipments from multiple vendors. This not only stretched resources but also led to patients receiving their supplies in a fragmented manner, creating inconvenience and complexity. For this cardiometabolic study, the sponsor was keen to avoid such pitfalls, and sought a solution that could streamline the process, enhance patient experience, and improve efficiency.
Reliable and convenient patient kitting service
Woodley Trial Solutions stepped in with a comprehensive approach designed to tackle the identified challenges. Our Patient Kitting Service offered a more streamlined and patient-friendly solution by focusing on three key areas. First, we initiated the service by reviewing the study protocol to ensure that the design of the pre-packed patient kits aligned with trial requirements. By tailoring kit contents to visit schedules, we ensured each kit was equipped with the necessary home-use equipment and consumables, allowing for efficient management of clinical trial supply.
To maintain a steady supply and enhance site efficiency, Woodley Trial Solutions developed a full trial supply plan that streamlined study rollout across geographies. Centralized inventory management, forecasting, and supply planning were incorporated into the plan. Depending on geographical needs, kit assembly was conducted either centrally or in-country, ensuring consistent quality. Additionally, the service included end-to-end logistics, with Importer of Record (IoR) services and full chain-of-custody tracking. This comprehensive project management support effectively reduced the resource burden on both the CRO and sponsor. By consolidating multiple vendors into a single point of contact, Woodley Trial Solutions provided a reliable partner in supply management.
Enhanced efficiency and patient experience
The impact of the Patient Kitting Service was evident through improved site efficiency, positive feedback, patient convenience, and seamless global trial execution. With over 8,000 patient kits required and around 3,000 dispatched, sites no longer needed to split bulk supplies or record serial/lot numbers, allowing clinical staff to focus on patient care and data collection. Sites reported a significant reduction in supply burden and praised the ease of dispensing pre-packed kits. Patients appreciated receiving up to three months' worth of supplies in a single, easy-to-carry kit bag, reducing the hassle of storing and transporting loose items and supporting better patient retention.
Furthermore, the service's scalability was demonstrated through successful deliveries across Europe, APAC, and the Americas. This ongoing study, involving over 2,000 patients across three continents, highlighted the capability to manage complex studies while ensuring reliable supply regardless of geographical location.
Summary
By centralizing supply management, reviewing protocols, and designing optimized kits, Woodley Trial Solutions alleviated burdens on both sites and patients. The result was improved site efficiency, a better patient experience, and stronger retention rates. For sponsors and CROs, this translated into reduced resource requirements and confidence in global trial execution.
