Last Mile Delivery – Overcoming the Final Frontier in Clinical Trials
In the final leg of a clinical trial’s supply chain, getting critical goods or samples from the delivery hub to the clinical study site, is known as last mile delivery. This stage plays a critical role in ensuring the integrity, timing, and accuracy of the trial, ultimately impacting patient safety and the reliability of data collected. Unlike standard logistics, last mile delivery in clinical trials demands a higher level of precision due to factors such as regulatory compliance, temperature control, and the absolutely necessity for timely delivery.
In this insight, we’ll explore the key considerations and best practices surrounding last mile delivery in clinical trials, and why it is essential to the success of these studies.
What is last mile delivery in Clinical Trials?
Last mile delivery is the process of transporting goods or samples from customs to sites, depot to sites or even site to site. In the case of clinical trials, this could mean to either the clinical study site, hospital or the patient’s home.
This phase includes the transportation of trial materials, ranging from investigational drugs, medical devices, biological samples and medical equipment to various sites. It is essential that these goods arrive on time and in the required condition, fit for the purpose they are intended.
Key Considerations
Temperature Controlled Transport
Many clinical trial materials such as IMPs, vaccines and biological samples are highly sensitive to temperature fluctuations. Maintaining a consistent temperature is imperative to preserve the integrity, efficacy and safety of these materials throughout the delivery process. Any deviation from the required temperature range can compromise the outcome of the trial results and be detrimental for patients.
In order to meet strict temperature requirements, specialised transportation methods are employed. These include refrigerated trucks and vans equipped with cooling systems designed to maintain specified temperature ranges, further packed into passive Insulated containers with PCMs to maintain further temperature control.
To guarantee that temperatures remain at the required level, real-time temperature monitoring devices such as data loggers and sensors are integrated into the transportation process to continuously track temperature and ensure compliance with required standards. Alerts are triggered in case of deviations, enabling any corrective measures to be taken swiftly.
Short-term Storage
Before clinical trial materials are delivered to the final clinical site, they may need to be stored temporarily at an intermediate point along the way. Storage facilities that align with the specific requirements of the materials covering a range of temperatures, may be necessary to ensure the safety and quality of products. Facilities can vary significantly covering refrigerated, frozen or room-temperature.
Regulatory Compliance
Clinical trials can often encompass multiple countries. This means that shipments have to adhere to a wide range of regulations that can differ from country to country. The delivery of materials will need to satisfy not only global standards but also adhere to each country’s unique regulatory requirements. Maintaining precise records of handling, including temperature logs and shipment tracking, is necessary to ensure compliance and meet audit standards, especially in the case of regulatory inspections.
Navigating customs and border control can also present challenges. Customs inspections of IMPs, vaccines and samples may result in unnecessary and indeed unwanted delays if documentation is not in order. This can disrupt the timing of the trial, particularly when materials are needed for patient dosing or critical phases of a study. Such disruptions can affect the overall trial schedule, jeopardising the integrity of the study and potentially causing costly setbacks.
Unpredictable Delays and Last Minute Changes
Traffic, adverse weather conditions or geopolitical events can disrupt last mile delivery. Clinical trials in remote areas or regions with underdeveloped infrastructure may be more susceptible to unforeseen interruptions. Natural disasters or political unrest can lead to extended delays and these events are often beyond the control of delivery teams. As a result, trial timelines can be affected, potentially delaying key research milestones and compromising the quality of the trial.
Clinical trials are dynamic and adjustments to delivery schedules, site locations or logistics may be necessary. However, when these changes occur late in the process, they cause delays and introduce additional strain on a supply chain. Swift, remedial action may be required to minimise disruption.
Last Mile Logistics from Oximio
The final stretch of delivery plays a crucial role in the success of clinical trials. Last mile logistics requires careful planning, collaboration and flexibility.
At Oximio, our qualified and experienced teams have been providing agile solutions to meet the most demanding clinical trials for over 20 years. With a global footprint our supply chain solutions include dedicated project managers who work with CROs and CDMOs from start to finish. Navigating logistics, regulatory requirements and patient care, our comprehensive solutions not only include, but extend beyond, last mile delivery.
Our full range of supply chain solutions can be viewed on our website. Or, if you are planning a clinical trial, why not contact us and talk to one of our experts and find out how we can support your research.