Scientific Support Case Study

Major pharmaceutical company turns to LabConnect: LabConnect’s Scientific Support Solves Sample Management Challenges While Ensuring Scientific Integrity in Clinical Studies

BACKGROUND: LabConnect provides functional and strategic resourcing services in the areas of scientific project management, sample management, contract management, and vendor management services to the pharmaceutical research industry. LabConnect uses a collaborative approach to efficiently meet the needs of the client through customized teams of industry professionals.

 

CHALLENGE: A major pharmaceutical company faced significant challenges managing the life cycle of its outsourced clinical and preclinical studies, particularly in the aspects of scientific oversight, vendor oversight, and sample management. Internal resources were spread too thin and these constraints were negatively impacting, speed, quality, and employee satisfaction. The client’s internal analysts were developing assays and transferring them to global laboratories while also juggling the management of vendors and overseeing assay performance. However, without centralized, dedicated oversight, clinical timelines and quality were being challenged.

SOLUTION: LabConnect’s Scientific Project Management and Sample Management focused on a strategic solution to provide comprehensive support alleviating the stress on

BUILDING A TEAM: LabConnect assembled both technical and operational experts with skills and personalities that aligned with the client team and technical demands of the studies and assays.

LabConnect’s scientific project managers began to manage the transfer of assays to analytical labs globally, where regulations vary with country. LabConnect managed the study throughout the entire duration, including end-of-study activities. The Scientific Project Managers focused on ensuring quality execution of assays, data oversight, vendor performance, and overall scientific integrity throughout the study.

A team of biological sample managers worked closely with scientific project managers throughout to ensure that all samples arrived at the appropriate analytical labs and discrepancies were resolved. They also ensured all sample testing was completed to meet study timelines. LabConnect’s sample managers acted as a hub between the central labs, analytical labs, study teams, data management teams, and internal and external stakeholders, facilitating sample logistics throughout the lifecycle.

CONDUCTING THE STUDY: The team-oriented approach undoubtedly increased efficiency and allowed for the necessary focus on the quality of execution and maintenance of outsourced assays and studies. LabConnect was also able to provide contract management support to this company to ensure that appropriate contracts were in place for all facets throughout the duration of these studies.

OUTCOMES: By employing LabConnect’s Scientific Functional Outsourcing services, the client improved oversight for its clinical and non-clinical studies, as well as the management of the analytical labs performing the testing. Sample managers alleviated the concern for missing timelines due to discrepancies with samples or results. LabConnect improved this company’s efficiency and ability to meet timelines, decreased overhead, enhanced overall quality and execution of all outsourced clinical and non-clinical studies – while allowing the company’s internal personnel to focus on their core competencies.

CONCLUSION: As a result of this partnership, the client has now contracted with LabConnect’s SciOps team to provide sample management and scientific project management support to nearly 100 percent of its outsourced clinical studies. Each sample management specialist handles approximately 30 studies, and LabConnect’s scientific support spans numerous functional areas including, but not limited to, bioanalytical testing for immunogeniciety, pharmacokinetics, biomarkers, medicinal chemistry, flow cytometry, and in vivo studies. The client’s clinical timelines were no longer compromised by lack of process, skill set, or inefficiency, resulting in significant time and cost savings. Additionally, the team-oriented approach created an improved environment for business continuity and quality. LabConnect’s solutions have reduced the client’s human resources costs in salary and benefits as well as time spent in recruiting, hiring, and training. Overall, the client has been able to return its focus to their core competencies and goals with the peace of mind that their outsourced studies are being overseen by highly skilled, reliable, and quality driven professionals.