Assay design, development and management is critical to long-term research opportunities. Tracking results across assay protocols is key to understanding both assay performance and duplicate results for the same specimen within a protocol or program. Tracking laboratory performance across sites and eras allows enhanced oversight for assays in clinical development. Tech transfer of in-house assays to externalized labs allows assay managers to review assay performance parameters to assure performance optimizes expectations.
Assays selected for generating data and clinical research are chosen for precision and the ability to deliver the right results for all patients. Therefore, monitoring assay performance across all labs is critical to ensure the results are accurate. GSS enables detailed assay tracking to monitor performance across labs and ensure data generated from the assay can be linked directly to the specific assay protocol used.
Monitoring live results across protocols is critical so outliers are identified for accuracy, safety and efficacy. GSS analytics provides the unique ability to view current results within the protocol and also within the context of the greater program.
Scientific innovation within internal labs is part of the core value to understanding drug performance in the clinic. However, converting those assays into the commercial space requires careful monitoring to ensure the precision at the commercial lab equals the precision at the development phase. GSS allows monitoring of assay precision from internal labs to external labs.
GSS monitors assay proficiency at test sites over time. This allows unique insights into repeat testing, cost of the assays per site, and overall assay performance per lab site.