In the dynamic landscape of clinical development, Diamond Age (DA) has solidified its position as a trusted bioinformatics partner of choice, particularly with respect to the handling of valuable patient samples. The following case studies demonstrate how DA’s tailored bioinformatics solutions played a pivotal role in helping clients navigate through complex clinical trial challenges, adapt to unforeseen circumstances, and make well-informed “Go/No-Go” decisions.
· A client trusted DA to help identify biomarkers of treatment response in an ongoing oncology clinical trial. Having recently lost their internal bioinformatics scientist, the client relied solely on DA for bioinformatics support. A senior DA consultant worked closely with the client’s head of translation to plan a custom analysis on tumor biopsy sequencing data. DA then conducted a comprehensive statistical analysis, including short variant calls and copy number calls, to derive meaningful insights from the data. The client used the results to confidently determine if any discoverable biomarkers were present in the patient set and was able to make a well-informed decision regarding the trial’s trajectory.
· A longstanding partner, overwhelmed internally, sought DA’s expertise to create a streamlined analysis process and enhance efficiency throughout the trial’s duration. DA deployed an alignment pipeline in the client’s cloud environment and crafted a customized statistical analysis plan for the client’s complex trial design. The client used the results to identify gene sets affected by the investigational treatment, allowing them to better understand their treatment and to identify relevant biomarkers to monitor in future patients. Close communication fostered timely adjustments and ongoing support.
· A client required expertise in single cell RNA sequencing (scRNA-Seq) analysis and engaged DA for assistance in gaining greater insight into adverse events that were reported within an ongoing clinical trial. Using scRNA-Seq to analyze cell type composition changes with treatment, DA’s custom analysis provided valuable insights on the cause of these adverse events, providing a pathway for further exploration as well as the ability to make an informed decision regarding the trial’s trajectory.