QuartzBio Helps Keep Oncology Trial on Track at a Clinical-Stage Biotech 

A clinical-stage biopharmaceutical company has been developing novel therapeutics that selectively modulate gene expression to address unmet medical needs in cancer patients.  

To keep their phase I study of an epigenetic modulator on track, the program’s translational research team needed to be able to monitor clinical outcomes with respect to patients and with respect to biomarker-defined subgroups. 

To achieve this goal, the team needed to manage multiple data streams: 

  • Central lab sample inventory 
  • EDC/Clinical data 
  • Assay results data from multiple specialty labs, including IHC, flow cytometry, PK, and gene expression 

Biomarker Data Management (BDM) & virtual Sample Inventory Management (vSIM) 

In weeks, QuartzBio deployed its vSIM and BDM solutions to the clinical trial in progress, enabling the translational research team to: 

  • Gain centralized visibility into status of samples as they move from sites to central and specialty labs 
  • Revealed insights on actual samples collected vs. expected samples collected 
  • Generate hypotheses based on biomarker assay results linked to patient clinical data and dosage information 
  • Eliminate time-consuming and manual data cleaning and cross-referencing processes
Biomarker Data Management in phase 2-3
Biomarker Data Management in phase 2-3

QuartzBio’s approach to biomarker data management can be seen in the context of a phase 2/3 dose evaluation and expansion oncology study with 5 assays run at 4 different labs. Using QuartzBio’s technology-driven solution, the sponsor could:

  • Pull together and visualize PK, cytokine, and flow cytometry data to inform optimal dosing
  • Integrate mutation, IHC, and cytokine data to develop a multimarker signature to stratify patients

The cross-functional QuartzBio team—including data scientists, biomarker data management programmers, and data managers—delivered a centralized data hub for biomarker data transfer, integration, and collaboration, as well as interactive reports and support for ongoing trial activities.

The client found that our approach transformed their ability to reach key clinical trial objectives.

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