Supporting customer success through powerful sample logistics and a global central lab network
Introduction
A leading Japanese pharmaceutical company chose to partner with Labcorp to provide central laboratory testing services for a complex regional clinical trial. Their flow cytometry (FCM) panel for immunology was planned for a duration of three to four years. The primary challenges were the short stability period (48 hours) of trial samples and the fact that all the trial locations were not yet determined. Labcorp’s efficient logistics enabled speedy shipping for reliable data. By leveraging its worldwide network of accredited central lab facilities that use standardized assays and procedures, Labcorp gave the client the flexibility to conduct trials wherever needed, while ensuring consistent and reliable data that was also combinable.
KEY TAKEAWAYS
- With multiple lab capabilities, Labcorp proved to be a customer-centric solution partner
- Provided efficient logistics for samples with very short stability periods
- Leveraged a global network of central laboratories for combinable data and flexible trial support
- Regulatory expertise allowed strategic interpretation of regulatory guidelines
The challenge
When a sample’s stability period is limited, sample logistics become increasingly complicated. For this reason, leveraging a local central lab facility is preferred, which Labcorp offered in Japan. However, Labcorp’s Singapore central laboratory services facility had the flow cytometry panel necessary for the trials. As an interim solution, Labcorp proposed shipping the samples from Japan to Singapore until the necessary technology was transferred to Labcorp’s local Japan lab.
Throughout this process, reducing risks to sample stability at each step would require specialized logistics capabilities. Thus, one of the client’s key priorities when selecting a central laboratory partner was strong sample logistics solutions. Labcorp was able to leverage its global sample logistics capabilities to pick up and ship samples from Japan to Singapore within particularly tight timelines. The client greatly appreciated the role Labcorp’s sample logistics played in the success of the clinical trial.
Global network of central labs
To support rapid decision-making in the clinical trial, speed and reliability of data are essential. Additionally, when managing data from more than one facility, combinability of data becomes crucial. At the time of selecting the study’s laboratory, the client was yet to determine the specific countries in which the trials would take place. Labcorp’s integrated network of central lab facilities offered a ready and flexible solution to this challenge. Regardless of their location, central labs within Labcorp’s global network have standardized processes, procedures and instrumentation, allowing for combinability of data. FCM assays are also available consistently across the network.
“The clinical trial started over 18 months ago and a lot of samples have already been tested. There were several challenges, such as the change of FCM laboratory (from Singapore to Japan), the need for cross-validation between FCM laboratories and the impact of COVID-19. However, we could address these challenges with the dedication and efficiency of the Labcorp team. This has resulted in reliable data and the success of the clinical trial. Rapid delivery of high-quality data can accelerate drug development and provide timely support for patients awaiting the drug.”
- Client
More than a lab: Labcorp as a solution partner
Labcorp’s operational flexibility and comprehensive solutions tailored to meet the sponsor’s needs demonstrated a customer-centric approach. Labcorp was committed to the approach even as the COVID-19 pandemic added to the complexity of the trials. During the pandemic, shipping samples between countries became more challenging. However, Labcorp successfully managed these challenges by aligning with internal operation teams as well as external partners. With seamless coordination, the samples were shipped and analyzed within the stability period.
With challenging logistics and accelerated timelines, strategic interpretation of regulatory guidelines is crucial. Labcorp’s deep understanding of regulatory requirements was thus key in successfully accelerating the client’s drug development program. It was particularly important to factor in the specific requirements of Japan’s regulatory guidelines at each step. Leveraging Labcorp’s local regulatory expertise allowed streamlining processes by eliminating unnecessary steps.
This minimized delays and improved efficiency and data quality. The client appreciated the multiple capabilities Labcorp brought to the table that enabled their success. In addition to providing comprehensive clinical laboratory testing services, Labcorp provides its clients end-to-end support in getting new drugs and indications ready for commercialization drugs. Labcorp believes in being a true customer-centric solution partner, providing regulatory and scientific inputs, technical services and operations, and launch support all in one place.
Learn More today about Labcorp Japan’s capabilities.