The process of ensuring clinical trial records are accurate and fully reconciled between laboratory and clinical data sources can be a point of frustration for today's pharmaceutical and biotechnology companies. Whether the data is coming from a contract research organization (CRO), a central laboratory or third-party laboratories, the need for timely availability of clean data based on unique sponsor format/industry requirements has become extremely complex.
"As the complexity of today's studies grow, sponsors are often working with a greater number of laboratories in their studies," explained Richard Cesarski, SVP, Patient Solutions, Safety and Data Sciences, Covance. "While these labs are specialists in sample management and generating results, their standard report formats may not be aligned to individual sponsor requirements."
Recognizing this gap between sponsors, their clinical partners and the labs, Covance has launched Laboratory Data Management FSPx (Lab FSPx), a new solution within its Functional Service Provider (FSPx) offering.
Meeting a Critical Need with Laboratory FSPx
The first deployment of Lab FSPx was started with two leading pharmaceutical companies, which were both experiencing issues with data currency and accuracy specifically in laboratory data management. In addition to providing flexible functional provider services, Covance FSPx helped them by developing and investing in customized robust laboratory data management solutions. The new solutions incorporated data standards, processes and a specialist team within FSPx that addressed all of their labs and related clinical sources, delivering data packages uniquely tailored for each clinical trial in their portfolio.
After successfully implementing new laboratory data management processes for these two sponsors, the Laboratory FSPx offering was expanded and is available to all sponsors.
"Based on our lessons learned and positive results from these experiences, we now know how to efficiently help sponsors achieve their data readiness goals," said Richard Cesarski. "This includes techniques to enable faster study start-up by implementing standards, lean processes and blended roles, while partnering throughout the trial—and even after its conclusion—to ensure all the relevant data is cleaned and available for submission."
Aligning Needs from Multiple Perspectives
To help sponsors better align their lab data with clinical data requirements, the Covance FSPx team draws on its knowledge that spans the clinical development side, the Covance central laboratory and the network of LabCorp specialty labs.
"Our teams at Covance already understand the varying requirements and perspectives within the lab and clinical CRO," explained Richard Cesarski. "We have coupled that knowledge with the experience of our very strong FSPx clinical data management team, which expanded significantly with our acquisition of Chiltern in 2017, and again with new capabilities in 2018 when we acquired Sciformix. Our data management professionals offer a specialized set of cross-functional skills, which are critical to building greater synergy between lab data and clinical data requirements."
Sponsors can now make use of Lab FSPx for customized global data solutions that manage laboratory data acquisition, data transfer specifications, data transformation and data reconciliation– the key to optimizing efficiencies for managing critical laboratory data within a study.
A Flexible FSPx solution
Sponsors continue to desire increased control and scalability while looking for ways to decrease their cost base for clinical research. Regardless of the CRO or laboratories being used to support a study, sponsors can work with Lab FSPx and apply it to their unique situation. The Lab FSPx team provides sponsors with a specialized group of highly experienced data managers, external data specialists, and clinical programmers who help clinical teams interface with central labs, local labs, and specialty labs – including biomarker and pharmacokinetics labs.
"Whether working in house or outsourcing, sponsors appreciate the advantages of end-to-end solutions that include their laboratory data management operations," said Paul Kirchgraber, MD, CEO, Covance. "With the Covance FSPx portfolio of capabilities, that now includes Laboratory Data Management FSPx, we are helping meet the growing demands of the industry with flexible, best-in-class solutions for clinical research."