Identifying alternative supplies to address global supply chain issues and deliver custom clinical trial kits

3 March 2022

Disruption across the global supply continues to challenge clinical trial operations, so the Labcorp Global Supply Chain Sourcing and Procurement team has leveraged Labcorp’s scale and expertise to reconfigure relationships with manufacturers and develop new processes for identifying and qualifying alternative supplies for customized clinical trial kits.

This article shares how the Sourcing and Procurement team has optimized processes, reduced the approval timeline for alternative supplies and worked proactively to address potential hurdles and better handle today’s environment of continuous change.

Responding to a sudden sourcing challenge

For each trial, Labcorp Central Laboratory Services creates protocol- and visit-specific kits that are customized and produced to meet the unique needs of each trial’s protocol. But with the COVID-19 pandemic, kit components suddenly became unavailable as many manufacturers had limited resources or had to shut down production.

What started as five to ten items out of stock quickly grew to over 100 items out of stock as manufacturers’ outputs dwindled. The Sourcing and Procurement team had to quickly identify new manufacturers to keep up with kit production demand. The team had typically imported kit components, many of which are manufactured outside of the U.S. using a “just-in-time” inventory model where supplies are ordered and delivered as needed.

However, even when a kit component became available, the team had to determine how quickly and effectively it could be shipped to Labcorp. What started as a sourcing challenge also became a transportation and logistics challenge as global port delays and nationwide driver shortages added to the complexity.

Faced with sudden shortages of kit components, the Labcorp Sourcing and Procurement team worked to:
• Add new manufacturers and establish direct relationships
• Increase the visibility of product needs with longer-range forecasts
• Identify and qualify alternative products
• Increase inventory stores to build resilience against future supply chain fluctuations

Leveraging manufacturing relationships and increasing visibility

Taking on these challenges from multiple angles, the Sourcing and Procurement team first assigned resources to reconfigure their relationships with kit component manufacturers.

The team already had strong relationships with their manufacturing partners, both within and outside the U.S. In addition to working with those partners, the Sourcing and Procurement team assigned dedicated resources to develop new supplier development relationships in key global regions. This team also worked to evaluate these potential vendors and ensure they would be reliable and stable sourcing partners, even when faced with challenges.

Next, the team expanded direct manufacturer relationships and communications to ensure Labcorp’s needs were clearly and consistently conveyed.

Building on these new and existing manufacturing relationships, the Sourcing and Procurement team has now increased its communications and gained deeper insights into production schedules to better understand upcoming supply based on their sponsors’ current demands. This approach has led to increased visibility as the team creates longer-range forecasts with new tools and technologies.

Incorporating alternatives and substitutes into the protocol

Understanding that some kit components could not be sourced due to manufacturing shortages and/or supply chain issues, the team worked to identify several alternative products that could be substituted, if needed.

In these cases of substitutions, each alternative product for a clinical trial kit must go through a rigorous, in-depth review, which involves multiple departments as well as Medical Affairs. Quality is the driving factor for these decisions, especially considering that some components must have 510(k) FDA approval or a CE mark.

With this approval process, drug development sponsors can be assured that any replacement component will function like the original component and will be used in the same way in the study to eliminate any potential study variability.

Finally, once the team finds and validates an acceptable substitute, they also verify that the manufacturer can reliably deliver it at the scale needed, highlighting the levels of coordination required to ensure a predictable supply for drug development sponsors. Labcorp Central Labs produced more than 8.4 million kits in 2021, each including an average of 20 supply items. To fulfill these volumes, they often are required to purchase entire manufacturing lots from suppliers.

Looking ahead to reliably meet demands for kits

The impact of the COVID-19 pandemic has inspired new changes across Labcorp’s Global Supply Chain organization as they work to enable business continuity and expect the unexpected. With a new level of coordination spanning manufacturers, distributors, logistics partners and study planning teams in the U.S., Europe and Asia, they continue to proactively mitigate risk and allow for more flexibility in study protocols with alternative products.

Beyond planning orders much further in advance, the team is aggressively building its internal inventory—at three to four times greater than its pre-pandemic capacity—to reliably meet sponsors’ needs for custom kits throughout the life of their studies.