Client success story
Diagnostics Lab Data Management and Validation
Business Value: Optimizing Data Flow & Systems Validation Accelerates Diagnostic Test Approval
Summary: Strategic Solutions for Cancer Diagnostic From Research to the Clinic
bPrescient provided strategy for, and extensive implementation of, robust lab data tracking systems in the customer’s research and clinical labs, producing systems that reliably track samples and reports, shortening the timeline for diagnostic product development and regulatory submission.
Challenge: Transitioning to a Scalable, Regulatory-Ready System
bPrescient engaged with a company working on early detection of cancer through a research lab and a CLIA diagnostic lab. The diagnostic lab has advanced pipelines for data analysis and is running trials with partners. The company was facing challenges in moving from a research organization to one that is handling patient data and preparing to run an FDA-approved test. They had ELN and LIMS tools but didn’t have the right templates and SOPs in place to use them effectively. The trial data being received from their partners was critical to their product’s success but was not organized effectively.
Solution: bPrescient Experts Enhance Data Infrastructure and SOPs
bPrescient engaged on multiple fronts to shore up the customer’s data infrastructure to support them across research and development. A team of bPrescient ELN experts worked to add templates and SOPs for tracking of reagents, assays, and results. We also supported the client as they migrated their CLIA lab to another lab data tracking system to run samples for their trials and ultimately their production diagnostic test. bPrescient also worked on upgrades to their platform for tracking data ingestion from trial partners, so that patient and sample information can be appropriately integrated with molecular results and critical trial results can be reported efficiently.
Outcome: Improved Tracking, Analysis, and Regulatory Readiness
The customer has systems in place to track their lab data and results in both research and clinical settings. They can more effectively analyze results with access to end-to-end data including reagents used and links to patient and clinical data. The data can now be linked to the results of the sequencing analysis pipelines which allows for better troubleshooting and identification of confounding factors. Trial participants’ results are reported in a timely manner and are visible to all stakeholders, which has been critical in moving their product forward and securing additional funding. The customer was so delighted with the experience of working with bPrescient that they have asked us to work on solving a wide range of additional challenges.
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