PK and ADA sample analysis using a proprietary Enzyme-linked Immunosorbent assay (ELISA) was required to support a PI oncology study in subjects with metastases
Immediate analysis was required for adverse events for this clinical study over a four year period. The sample arrival dates were not predictable however turnaround time for sample analysis and data delivered to the client was to be within one week after sample arrival
Approach
Implemented a process in collaboration with the client and supply chain, to ensure key reagents would be available for the duration of the clinical study
Developed a flexible scheduling approach within specific timelines, and ensured trained staff were available to perform the required assays to meet the client’s needs
Benefits
Data delivered to the client within their requested timelines to ensure they were able to assess the adverse events based on the available PK and ADA results
Drug dosages could be adopted appropriately to assure patient well-being
