The Value of Integrated Services
Supporting the delivery of clinical trial materials requires more than a logistics service provider. Clinical trials are growing in number and complexity. More trials are dispersed over many locations in different countries of the world with varying regulations impacting the operating of clinical studies and the import/export of clinical trial materials. Often, patients are located in rural/remote areas and receive their medications and treatment in the home, rather than at investigator sites. Drugs are also becoming more complex, more sensitive to environmental conditions and more expensive.
Pharmaceutical companies need a partner that offers one-on-one customer service that ensures high quality, responsive, tailored support from start to finish. This type of holistic relationship can only be achieved with a solutions management approach that encompasses integrated logistics, warehousing and packaging expertise combined with customized project management support, planning and optimization guidance, comparator sourcing, ancillary supply sourcing, forecasting and returns/reconciliation management.
As the only truly integrated premium courier and clinical packager in the market, Yourway has adopted this approach. Through our global GMP-compliant depot network, which includes more than 20 global locations wholly operated by Yourway, we provide integrated services, including comprehensive transport of drug products and biologic samples, primary and secondary pharmaceutical packaging, warehousing and distribution support, including temperature-controlled solutions, unused product return services and assistance with logistics project management. The ability to access packaging services and courier/shipping services from a single provider creates unique opportunities to ensure a seamless clinical supply chain with maximal visibility and HIPAA-compliant and clinically blinded data security.
Integrated Shipment Tracking
Yourway’s central, web-based portal tracks all types of shipments and provides access to all relevant information about those shipments at any point in time throughout the course of transport. Some clients choose to use this portal, while others prefer to use their own Interactive Response Technology (IRT) systems. This choice is common for studies involving blinded information, because it allows clients to view inventory data in a blinded manner.
Yourway has established protocols for ensuring that our central database is synced with client IRT systems. Updates of shipment and tracking information are made constantly to client IRT systems so clients can view all of the data in a central place in real time.
From the Packaging Line to the Depot
Once a product comes off of the packaging line, it is received into inventory, and the unique number, expiry date, lot information and physical location are entered into the management system. At this point, the material is in a quarantine status –– the location and other data have been confirmed, but the finished good has not yet been released for activities downstream from packaging. That will not occur until the GMP documentation has been reviewed by Yourway’s quality assurance group and then released for distribution from that specific warehouse by the client or CRO.
The packaged product is then released for distribution to other Yourway depots with proximity to the various investigational sites and patients involved in the clinical trial. Once the correct depots have been seeded with the product, it is then released from each depot to the investigational sites by the client, according to protocols specific to the country and/or regions.
At this point, the e-clinical system manages the supply and resupply of the product. The inventory in the client IRT system is synced with Yourway’s data management system to track the physical inventory at each depot location. When an investigational site performs a transaction, the IRT system determines which depot supplies that site and checks the inventory. It also calculates the future needs of the site and makes sure that adequate quantities are on hand at the relevant depot. Order placement is also typically handled by the IRT.
Underlying all of these activities are specific controls designed to ensure adherence to expiration dates. Warnings, alerts and cutoffs are built into the system to ensure that materials near their expiration date are not shipped to sites. These controls vary from product to product and kit to kit based on the expiration date and the number of days of treatment included in each kit.
Managing Data for Blinded and DTP Trials
Management of sensitive data is a key challenge. For blinded clinical trials, much of the information shared between our clients’ IRT systems and our centralized data management system to ensure accurate and efficient product supply cannot be seen by sponsors/CROs and physicians. Yourway is cognizant of the importance of allowing unblinded system interactions while carefully managing the data that is visible to end users. Our web-based tracking and other systems are designed to utilize unblinded data while making sure that users only see the information they need.
The same is true for direct-to-patient (DTP) trials, where the system that manages drug shipments to patients must have access to sensitive patient data that cannot be shared with anyone other than the patients’ physicians in order to coordinate delivery. This information is entered and retained in a location within the system that is separate from the module used for randomization and drug assignments and redacted from delivery confirmation notices received by sponsors/CROs. Controls are also in place to ensure that this patient-specific information is not retained or published anywhere electronically, in compliance with HIPPA requirements.
Reverse Logistics Support
All materials in a clinical trial must be accounted for, whether they have been administered to a patient or remain unused at the investigational site or depot. Specific requirements for return and/or destruction vary from country to country, but in all cases reconciliation of 100% of the material must be achieved. Yourway’s inventory system facilitates the reverse logistics process by incorporating a module that allows the recording of return receipts against shipments as material is returned. Quantities of material shipped from and returned to the depot can be readily monitored, allowing identification of gaps and narrowing of the possible causes as the trial progresses. Yourway is also positioned with its geotracking technology to support clients in the return and re-inventory of expensive, sensitive biologic materials.
Innovation in drug discovery and development is driving the need for innovation in logistics technologies. For sponsor companies, efficiently and effectively managing the supply of the specialty clinical materials and patient samples used in and generated by trials of today –– and into the future –- requires partnering with a clinical logistics company committed to providing customized, holistic solutions that does not rest on its laurels. Continuous improvement and the ongoing development of new packaging, sourcing and other logistics solutions is also essential to ensure that management solutions for clinical trial logistics continue to meet the evolving needs of the industry.