Supply chain disruptions and manufacturing shortages have significantly affected the clinical trial industry, an issue exacerbated by an unprecedented demand for clinical trial kits. To help maintain business continuity, the Labcorp Central Laboratories team had to develop creative operational solutions at every step of production and quickly accelerate the launch of their new automated kit production facility in Europe.
This article shares how the challenges associated with the pandemic have inspired enduring change with new processes that enhance quality, provide additional flexibility and better manage unexpected spikes in demand.
Managing a rapid resurgence of clinical trials
As many countries eased their COVID-19 restrictions, clinical trials that had been paused were ready to work with patients again. The Central Lab team had predicted the advent of this increased demand and had already started scaling their kit production operations to handle twice the normal capacity. However, the resurgence exceeded expectations and the demand for kits quickly grew to three times the standard volume.
Managing demand at the Indianapolis kit production site started with increased staffing and additional shifts. The team hired more than 1,700 people initially and added extra shifts. Current staff also helped address the surge, spending extra time after the workday and even over weekends. The team has now hired more than 2,000 new people to meet global sponsors’ needs.
In addition to hiring more employees, the Central Lab team also examined their supply chain to determine how they could reduce turnaround times at every stage of the kit production process, including the transportation of kit components. First, the team worked to accelerate transportation so as soon as a kit component was available, it would be shipped to Labcorp. In many cases, the team used air transportation instead of ground shipping and even called in its Labcorp fleet to cut days off the transit times.
Meeting needs in Europe, the Middle East and Africa (EMEA) with a new kit production site
The Labcorp Central Laboratories team had been planning to increase kit production capacity by opening a second production site, expanding the capabilities of their centrally located EU Operations Center in Mechelen, Belgium.
The planned construction of the kit production site had started in March 2020, just as the pandemic emerged. Despite pausing work for two weeks during the government-mandated lockdown, the team quickly accelerated the process of building out the site, installing equipment, adding automation elements to the line and hiring people. These efforts resulted in opening the facility three months ahead of schedule.
Historically, around 40% of the overall kit production volume has been destined for clinical trials in EMEA. Now, with the EU-based kit production site, the Labcorp team can better respond to region-specific demands and help balance the global demand for custom kits.
To ensure continuity, the EU site uses the same system as the Indianapolis site, following the same process and quality targets so that a kit built in Indianapolis will be the same as kit built in Mechelen for EMEA sponsors.
Maximizing kit production output to handle future spikes in demand
At both the U.S. and EU sites, the teams continue to implement new ways to maximize output and increase efficiencies, reflecting on lessons learned from the last year. While scaling up to two to three times capacity was not a simple task, the team is confident they are better prepared for future spikes in volumes to meet sponsors’ needs.
The team remains focused on anticipating future demand and finding new ways to optimize the sample lifecycle process—from kit production to sample destruction. They continue to invest in technology and automation to appropriately scale and meet the needs of growing markets around the world. Learn more about our central laboratory capabilities to create protocol- and visit-specific specimen collection kits for your global clinical trials.