An increasing number of clinical trials in areas such as immune-oncology, cell and gene therapy, and rare disease require the utilization of local laboratory support for screening and safety testing. Since different local laboratories may use different normal ranges and units, the management of these data can present many challenges for sponsors and investigator sites. In this webinar, an overview of a local laboratory standardization process will be given to demonstrate how these processes can be optimized.
The standardization process described in this webinar aims to capture and report local laboratory data quickly, accurately, and cost-effectively. The process standardizes local lab data collection through a double-data entry module into a clinical database and then is pushed into a normalized table, extracted, and delivered in a unified dataset.
Register for this webinar to get an overview of the challenges with working with local laboratories, learn the intricacies of data normalization, data process flow and how this process can be optimized.
Danuta Kuszczak, Ph.D., MS, Sr. Director of Project Services, LabConnect
Danuta Kuszczak is a Sr. Director of Project Services at LabConnect. She has extensive knowledge and experience working in academia and central laboratory industry. Her key areas of expertise include operational management and overall direction, coordination, implementation, and execution of domestic and global cross-functional or single service projects. Kuszczak received a doctorate in chemistry from Technical University of Gdańsk, Poland, and she holds a MS in chemistry from Nicolaus Copernicu University in Toruń, Poland.
Jim Carter, MLT(ASCP)CM A.A.S., Manager, Data Management, LabConnect
After 14 years as a quality auditor and supervisor in the auto manufacturing industry, Jim Carter made the transition into the clinical laboratory world. His experience includes performing standard patient diagnostic assays to blood bank and specialty testing such as chemiluminescent detection methods. In 2014, he again transitioned into the clinical trial setting with LabConnect. Jim has led LabConnect in establishing a full-service data management platform: from this platform validated, customizable, complex, and unified datasets can be generated from an integrated database.
Who Should Attend?
- Research Operations
- Translational Science
- Clinical Operations
- Sample Management
What You Will Learn
In this webinar, participants will learn about:
- Challenges working with a local laboratory
- Data normalization
- The data process flow
- The benefits of normalization
Connect with LabConnect—the preeminent provider of central laboratory support services for analytically and logistically complex studies such as immuno-oncology, cell and gene therapies, and rare & orphan diseases. We offer unique and innovative services that have been specifically designed to meet the exacting demands of today’s clinical trials. Our worldwide scope of services includes routine and specialized testing, real-time sample tracking, data integration, biorepository, sample processing and specialized functional outsourcing. Leading the evolution in central laboratory services since 2002, our services are customized to fit the unique needs of your trial. Get connected by requesting a proposal at www.labconnect.com or via email at [email protected]. LabConnect’s Scientific Functional Outsourcing support includes: Biospecimen Management, Scientific Project Management, Vendor/CRO management and oversight, Preclinical and clinical project management, Analytical assay validation and transfer, Computational biology and data analytics, Contract administration