Numerous factors are changing the way clinical trials are conducted. Increasingly complex trial designs, global patient groups, and decentralized trial models have significantly impacted how trial information is tracked and managed. These factors have also influenced how clinical professionals manage trial supply and inventory.
Getting drugs to sites in an accurate and timely manner while maintaining compliance is a challenge. This challenge is heightened as research teams plan to conduct trials at new sites and regions. The complexity is multiplied when adaptive trials are designed with requirements to change dosages throughout the course of the trial. Add a mix of decentralized and hybrid trials, and you have quite a challenging environment to ensure the proper delivery of drugs to trial participants and their healthcare providers.
The layers of complexity are constantly expanding. Clinical trial supply and inventory management are fundamental to the success of any trial. These processes require an understanding of the drug supply chain, including supply depots and sites, as well as the relevant regulatory frameworks within each region.
In a large trial, hundreds of sites and thousands of patients count on getting the right drug at the right time. The timelines, quantity of patients, changes to treatment plans, and basic logistics demand a technology solution. However, a collection of multiple point solutions is commonly used to track and manage trial supplies. These solutions innately create a lack of transparency across the trial supply chain, which builds needless rigidity into the supply chain and supporting processes.
The point solution approach removes the ability to automate, track, manage, and report on overall supply chain activities. It also obstructs broader views throughout the clinical trial that enable quicker responses and typically lead to greater efficiencies. The entire approach can potentially erode any confidence that the right controls are in place to reduce risks and keep the trial moving forward. An end-to-end view of trial supply and demand helps teams plan to stock product with an understanding of enrollment rates as well as the number and length of treatment plans.
When trial teams have visibility into inventory, they can proactively address potential supply issues. iMednet’s randomization and trial supply management (RTSM) functionality is a native module and component of the iMednet platform. It enables teams to deploy complex and simple schemas with full blinding functionality, while also controlling when sites can perform randomization. This powerful view offers complete visibility into inventory from shipment to receipt at the site to patient assignment.
As part of a comprehensive eClinical solution, the module offers the flexibility and functionality required to highlight opportunities for early intervention. Users can potentially reduce drug supply overages and shortages and create efficiencies that reduce trial costs. They can track supplies from source to site and use the data to inform connecting processes and stakeholders. iMednet Trial Supply Management makes it easy to manage investigational product inventory, including auto assignments, auto resupply, manual requests, shipments, tracking, and reporting. It also enables the use of multiple supply depots, a critical component as research designs become more complex and global. Multiple supply depots are critical to support different geographic regions or varying product and dosage types.
Supporting technologies must keep up with the dynamic nature of clinical trials. As complexity increases, flexibility and functionality will be critical. Clinical trials will continue to demand solutions that enable strategic planning and execution of clinical trial supplies. To learn more about Mednet’s trial supply management capabilities, contact us.