As COVID-19 was declared a pandemic, our Clinical Trials Testing Solutions (CTTS) witnessed a sudden influx of COVID-19 studies from both large pharmaceutical organizations and biotechs.
Not only did CTTS need to accelerate the timelines for these drug development sponsors’ urgent studies, but they needed to provide patient-centric testing solutions, ensure rapid method development and validation and navigate complex logistical challenges with courier services.
Ryan Baehl, Vice President of Global Operations at CTTS, recently shared the three key areas where the Central Laboratory Services (CLS) team within CTTS adjusted their practices to rapidly adapt during the pandemic and how these solutions will help accelerate laboratory timelines and reduce patient burden beyond the pandemic.
Reducing study startup time with combined capabilities
Understanding the urgency of COVID-19 studies, the team first examined where they could shorten study startup times.
“We created a type of ‘SWAT team’ with key departmental roles,” explained Ryan. “From the award of a study to the kits being shipped to the investigator site, we achieved startup in as few as five days, which is more than a 90% reduction from the traditional timeline. Our bioanalytical teams also pulled together experts from across the organization to validate an assay for a COVID-19 trial within three weeks, which is about two-thirds faster than our average method validation process.”
The CLS team also capitalized on the Power of the Combined – the combined expertise and capabilities of the diagnostic and drug development businesses across Labcorp.
“As our Labcorp diagnostic colleagues developed PCR and serology testing, we built upon their work to make the testing available for clinical trials within a month, which is more than a 50% reduction in our normal timeline for validating assays,” said Ryan. “We are also supporting Labcorp with diagnostic testing at our Indianapolis, Indiana facility, which is on track to regularly process 50,000 COVID-19 tests per week.”
Increasing patient centricity to promote enrollment and safety in clinical trials
Meeting sponsors’ needs during a pandemic required a holistic approach that examined the role of central laboratory services across the life of a trial.
“Even before the pandemic, we knew that clinical trial participants are interested in minimizing the amount of travel required for study visits. In today’s environment, they’d also like to avoid hospital settings, if possible, to reduce their potential exposure to the virus. We have been able to use Labcorp Patient Service Centers along with several decentralized clinical trial services, such as home health phlebotomists and home health nursing services, which can reduce patient burden and help patients stay enrolled in a trial,” explained Ryan.
Implementing unique courier solutions to achieve sample stability
As travel routes became restricted with border closures and widespread flight cancellation, the CLS logistics team played a key role in minimizing the impact on sample stability and ensure high-quality specimens were received on time.
“Logistics was one of the most disrupted parts of the pandemic as we worked to move samples from the investigator site to our facilities,” said Ryan. “To deliver on our promise of accelerated asset development, we had to come up with creative solutions to use multiple couriers, who typically don’t work together. We set up a new system for them to hand off packages midstream and deliver them to our facility within stability.”
Due to this unprecedented level of coordination, 96.9% of all samples were received within stability – an impressive achievement given the scope and magnitude of this crisis situation.
“The logistics team has been working 24/7, from the time the outbreak was first detected in China,” added Ryan. “Accomplishing nearly 97% of our samples received within stability is pretty impressive, considering the level of disruption that happened globally.”
Going forward, the logistics team has uncovered new transportation lanes and continues to strengthen partnerships with couriers.
“We now have an early warning system with our couriers that allows us to know when any of our samples or shipments are expecting issues. Our logistics have become even more robust as a result of COVID-19 so we can help minimize risk for any future waves of the pandemic.”
Looking ahead to apply lessons learned
To better support both large pharmaceutical and biotech sponsors with their clinical trial testing in the future while flexibly adapting to rapidly changing situations, the CLS team has examined lessons learned from the pandemic and added to their best practices. Going forward, they will continue to evaluate and refine their solutions to ensure they can continue to meet sponsors’ needs, keep timelines on track and help enable more patient-centric testing as the world returns to the “new normal.”