flow cytometry data management QuartzBio
flow cytometry data management QuartzBio

Our client’s translational research team needed to be able to monitor clinical outcomes with respect to patients and biomarker-defined subgroups. Within weeks, QuartzBio deployed virtual Sample Inventory Management and Biomarker Data Management solutions for the clinical trial in progress, enabling the team to:

  • Gain centralized visibility into status of samples as they move from sites to central and specialty labs
  • Reveal insights on actual samples collected versus 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

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sample data multiple trials QuartzBio
sample data multiple trials QuartzBio

One of the core challenges faced by clients in biomarker-informed clinical trials is the integration of key sample and subject metadata derived from multiple independent sources. One case involved multiple immuno-oncology studies, with data coming from multiple sources, in multiple formats.

The QuartzBio® platform was deployed to create a Master Sample Inventory view, yielding answers to key on-study questions, such as:

  • How does the number of available plasma samples compare to the number of available FFPE samples for Study X?
  • What proportion of samples have data available? What’s the breakdown of data availability by sample type?

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data management KPIs clinical trials
data management KPIs clinical trials

The translational research teams at a clinical-stage biopharma client rely on QuartzBio to report to stakeholders on how their clinical programs are progressing. Together with the clinical data management team, they can monitor vendors, turnaround times, and gaps in contracts – across the entire program.

Using dashboards on the QuartzBio Data Platform, the team can deliver executive summaries and presentations to investors, guiding key decisions and projected timelines.

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clinical sample KPIs trials
clinical sample KPIs trials

The clinical operations team at a mid-sized oncology biotech client depends on QuartzBio’s virtual Sample Inventory Management solution to gain global visibility into their expected sample schedule, across all collection sites.

They can identify gaps in sample data and sample shipments. Full oversight enables the team to identify data discrepancies, consent violations, and subject exclusions.

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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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