Biomarker Operations Archives - Page 3 of 3

Duration: 30 minutes

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Summary:

“Sample tracking and reconciliation are so much easier when all information around sample status, consent, and location are in one place.”
–Director of Biomarker Operations, QuartzBio Client Company N

Watch our webinar to learn how our clients, representing major biopharmas and biotechnology companies, have eliminated tedious data management processes and costly delays with the QuartzBio^® virtual Sample Inventory Management SaaS solution.

QuartzBio’s Adam Brown, PhD, demonstrates new capabilities of our technology, enabling teams to:

Track samples across every stage of their lifecycle with dynamic reports comparing actual and expected sample status
Proactively monitor sample stability and consent expiration with automated notifications
Quickly and accurately identify samples to ship for testing using intuitive Sample Ship List generator
Report on portfolio-level metrics and vendor and site performance across all clinical programs, including closed and active studies, to inform future planning

Adam also shows QuartzBio’s reimagined user interface*, which empowers teams to gain insights efficiently without requiring data expertise. Whether you are a current user or learning about the technology for the first time, you will learn new ways to immediately begin streamlining your work.

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*Current QuartzBio Users: Questions about when you can expect rollout of the new user interface for your account? Contact us!

4 Strategic Imperatives for Biomarker Operations - QuartzBio

Keeping track of clinical trial samples across multiple sites and vendors can be manual and tedious — we have demonstrated how Sample Intelligence can streamline the day-to-day reporting of sample collections, shipments, and discrepancies.

Duration: 30 minutes

Register to Watch On Demand:

Summary

Clinical and translational teams must monitor biomarker samples across global site footprints and dispersed networks of labs and biorepositories.

It’s easy to get bogged down by managing the day-to-day requirements of keeping studies on track. With samples as the critical first step toward data generation, modern trials demand a unified approach for evaluating vendor and site performance and their impact on sample operations.

Join our webinar to learn how our team has been working with sponsor clients to create program- and enterprise-wide visibility into site and vendor metrics that inform future study planning.

We will show how clients are using key performance indicators (KPIs) including:

Protocol & consent deviations – compare planned vs actual events at sites and labs, including unexpected or unconsented sample collections
Turnaround times – monitor sample receipt to testing and data delivery
Sample handling & movements – uncover trends at sites and vendors, such as samples that have been delivered past processing windows
Sample metadata – including processing volume and quality metrics such as cell count and viability

You’ll see how teams are gaining visibility into these KPIs to streamline daily operations, while simultaneously revealing program-wide insights.

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Streamlining Vendor Oversight with Sample Intelligence - QuartzBio

The challenge: Maintaining clinical trial timelines dependent on vendor performance

A global biotechnology company with seven clinical-phase programs approached QuartzBio with a challenge shared by many organizations in the industry — overall assessment of clinical trial vendors and sites was time-consuming and unreliable, given global site footprints, complex sample lifecycles, and inconsistent naming across sites and vendors.

Tasked with preparing regular executive summaries, the company’s clinical and biomarker operations teams were spending significant time deriving trial-wide key performance indicators (KPIs), lacking visibility into vendor performance – and challenged to translate current experience into future study planning.

This lack of visibility was exacerbated by the absence of standard nomenclature and inconsistent data entry across vendors. Clinical operations teams were spending time manually mapping and reconciling data and metadata from multiple independent sources.

The QuartzBio approach: Continuously updated visibility through consolidated dashboards

The client implemented the Sample Intelligence solution, powered by the Precision Medicine AI Agent Platform

Using the platform’s built-in dynamic dashboards (examples shown in Figure 1), augmented by some bespoke reports custom-built by QuartzBio for the client, the clinical operations team was able to easily monitor and report on multiple vendor performance parameters:

Turnaround times from sample collection to sample processing to test result generation
Completion rate of samples tested within stability window
Sample processing quality KPIs by site and vendor
Rate of missed/incomplete baseline and on treatment collections
Data discrepancies by site and vendor
Protocol violations by site and vendor
Consent violations by site and vendor

Core to QuartzBio’s approach is rigorous sample data integration. The Sample Intelligence solution automatically harmonizes sample information from multiple sites, vendors, and other sources, regardless of format or nomenclature. QuartzBio applies an adaptive data dictionary that learns and updates common nomenclatures over time, creating a flexible model. Using this model, it harmonizes the non-standard nomenclature across vendors and studies, enabling clear visibility and eliminating manual processes.

The outcome: Fast, accurate reports, timely decisions, course correction on-study

Empowered by 24/7 access to vendor performance, visibility into expected sample schedules, and full reconciliation oversight, the client’s clinical operations teams started using the solution for generating visualizations to guide executives and inform investors.

These visualizations enabled the client to take action at specific sites and vendors that were underperforming. Armed with more reliable trends in sample schedules and turnaround times, the biomarker operations team could more accurately project data delivery timelines and anticipate when key decisions could be made.

Sample Collection Status — Figure 1. Clinical Site Sample Collection Performance Dashboard. Using this and other clinical KPI dashboards on QuartzBio’s platform, the client could evaluate vendor and site performance within and across studies.

Sign up for our webinar, “Taming Clinical Sample Chaos,” to learn about the latest reporting capabilities available to users of Sample Intelligence solution.

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February 9, 2022 — Clinical operations leaders use the QuartzBio^® virtual Sample Inventory Management (vSIM) solution to maintain robust visibility across sample collection and processing status, consent status, and sample and derivative quality information.

Traditionally, generating these reports is frustratingly time-consuming – often involving spreadsheets that attempt to manually link key information from the EDC, central labs, testing labs, and biorepositories to illuminate critical information like discrepancies or missed collections.

The QuartzBio team has identified six critical on-study reports that our clients prioritize as absolutely required for effective sample and biomarker operations.

October 8, 2021 — Sponsors are challenged to keep track of complex sample inventories, both on study and for samples collected as part of completed studies that might be later mined for translational research needs. We frequently hear that teams spend significant time manually cross-referencing spreadsheets of inventory data, to answer questions such as:

“How many whole blood samples with a particular mutation do we have across all phase I studies?”
“Can we report sample expiration status across all of our contracted biorepositories?”
“When we identify a sample of interest, how can we confirm consent status?”

Connecting LIMS to Master Sample Inventory - QuartzBio

Complex biospecimen operations are inherent in modern clinical trials. For recent protocols, biospecimen collections are designed to be broad and to enable flexible selection from the variety of biomarker assay technologies that are available. Biomarker clinical operations are critical to realizing the potential of biomarker data generation plans.

Multiple Labs, Multiple LIMS; Lack of Sponsor-Centric Visibility

Given the expanding footprint of sites, labs, and biorepositories, there is no sole source where sponsors can find information on biospecimens and get insights into the whereabouts of a given specimen within its complex journey across sites, labs, and biorepositories.

In this post, we explore the relationship between “lab-centric” and “sponsor-centric” sample inventory reporting, and how connecting these inventories can keep data generation on track.