Modernizing sample operations with QuartzBio’s Sample Intelligence solution

About the Client

A Top 5 global pharmaceutical company managing more than 100 concurrent clinical trials came to QuartzBio seeking to increase their R&D pipeline capacity without having to add headcount. They needed to move faster, operate smarter, and scale rapidly, all while keeping compliance and data quality intact.

This case study follows their journey from fragmented, manual sample operations to a fully connected, AI-powered workflow. The study showed that automation and unified sample intelligence can deliver both immediate operational improvements and long‑term portfolio and team scalability across complex global clinical programs.

The Challenges

Managing biospecimens across dozens of global clinical programs posed operationally challenging, and the client’s sample operations teams were stretched thin. The tools and systems they were using were not keeping pace with their needs.

Three core pain points stood out:

  • Fragmented systems: Paper logs, spreadsheets, and disconnected platforms created silos that made it difficult to get a clear, unified view of sample data.
  • Time‑consuming manual workflows: Routine tasks like copy-pasting files, consolidating informed consent data, and reconciling records across systems consumed hours that could have been spent on higher-value work.
  • Lack of sample lifecycle visibility: Teams had no reliable way to track sample counts, flag missing samples, project upcoming collections, or confirm consent completeness.

The path forward required two things: (1) unified, harmonized data that all stakeholders could access, and (2) a measurable reduction in the manual effort required to keep that data current.

The Solution: QuartzBio’s Sample Intelligence Solution

The client team implemented QuartzBio’s Sample Intelligence solution, the industry’s only connected, AI-powered solution spanning the entire clinical sample lifecycle—from collection to assay insight.

The solution combines deep domain expertise in data management and sample lifecycles with compliant (21 CFR Part 11, GxP / ICH E6 (R3), GDPR, HIPAA) business intelligence. The secure, interoperable platform provides automated data ingestion, harmonization, query tracking, sample lifecycle monitoring, consent tracking, and real‑time analytics powered by AI agents to unify, monitor, and maintain high‑quality biospecimen data across studies and vendors.

Throughout the case study period, the Sample Intelligence solution delivered broad impact across four client use cases:

Use Case 1: 360° Sample Visibility

  • A harmonized Master Sample Inventory integrating lab, EDC, and consent data.
  • Full visibility into shipped, analyzed, missing, or stable/unstable samples.

Use Case 2: Sample Data Quality

  • Automated detection of discrepancies across files.
  • Automated query tracking, resolution insights, and root‑cause visibility.
  • Identification of previously unknown data issues, improving data integrity.

Use Case 3: Sample Collection Monitoring & Compliance

  • Identification of samples not collected and visibility into expected vs. collected counts.
  • Projections of upcoming sample collections.
  • Support for ICH E6(R3) through timely detection of compliance risks.

Use Case 4: Sample Logistics & Testing Monitoring

  • Real‑time tracking of sample status, location, and chain of custody.
  • Monitoring of sample stability, duplicate testing, shipments, and testing status.

Outcomes

The teams achieved dramatic efficiency improvements, including:

  • 85% reduction in time spent on sample‑related tasks (Table 1)
  • 100% detection rate for missing samples and automated query generation.
  • Significant reductions in data ingestion, reconciliation, consent tracking, and Excel®‑based processes.
TaskTime Required
Without QuartzBio		Time Required
With QuartzBio		Impact
Data ingestion & file creation527 min24 min82% faster
Sample collection monitoring120 min2 min98% faster • 100% missing sample detection
Query tracking automation120 min10 min92% faster • 100% automated query generation
Manual Excel® manipulation143 min8 min87% faster
Consent tracking completeness40 min5 min88% faster • 100% consent documentation
Data reconciliation120 min3 min98% faster
Table 1. Automated tasks accelerated sample management. Sample operations tasks were completed an average of 85% faster, with some tasks up to 98% faster.

Capacity Expansion*

Because teams were spending dramatically less time on routine tasks, they could take on significantly more work — without adding headcount. Study capacity doubled across both early-phase (Phase I) and late-phase (Phase II/III) trials, representing an increase of 100+ trials managed by the same team (Figure 1).

Clinical Trial Capacity Increased with QuartzBio Sample Intelligence - Top 5 Pharma Case Study

Figure 1. Increased capacity: By implementing QuartzBio, the client increased their study capacity by 100+ trials without adding headcount.

Financial Impact**

The efficiency gains translated directly into cost savings. Using a fully loaded FTE cost of $250,000 (as cited by the client) and the observed 85% reduction in sample data management effort, the savings per study ranged from $196K to $283K, with a reliable planning midpoint of approximately $239K per study.

Scaled across a portfolio of 100+ trials, that represents the potential for hundreds of millions of dollars in efficiency gains — without compromising quality or compliance.

Qualitative Outcomes

  • Improved data quality, completeness, and timeliness of monitoring.
  • Earlier detection of issues that previously went unnoticed, reducing the risk of patient data loss
  • Strong cross-functional adoption, with 100% of users recommending the platform for continued use

In Their Words

At the close of the case study period, 100% of users reported that they would recommend the QuartzBio platform and Sample Intelligence solution. Here are a few of their comments:

“I was able to reduce manual reconciliation efforts and follow-up communications related to sample status and discrepancies.”

“Sample Intelligence (SI) was able to identify a pattern of data discrepancy– which identified a potential issue with our requisition form. That demonstrates the purpose of SI for our organization. No one had raised this as an issue previously–SI allowed us to identify this issue. This allowed us to fix a problem we wouldn’t have ever known about.”

Methodology

*Methodology used to calculate increased sample operations capacity:

Users reported the time required to complete key sample operations tasks before QuartzBio’s solution was implemented and again after implementation to quantify time savings. We then incorporated the proportion of a typical sample operations role dedicated to these tasks to determine realistic FTE impact. Finally, these reductions were applied across the existing trial portfolio to estimate the overall increase in capacity that the solution enabled.

**Methodology used to calculate financial impact:

We quantified the per-study financial impact of an 85% efficiency gain applied to sample data workflows. Using the typical team FTE range of 0.90 to 1.30 FTE, the reduction yields 0.765 to 1.105 FTE saved per study. When applying the fully loaded cost of $250,000 per FTE as cited by the client, the resulting savings ranged from $191,250 to $276,250 annually. The midpoint of this range—approximately $233,750—serves as a reliable single-value estimate for planning and forecasting.

Looking Ahead

This case study demonstrates that when sample data is unified, automated, and accessible in real time, teams can achieve 85% faster task completion, 100% missing sample detection, doubled study capacity, and more.

These savings emerge from reductions in manual reconciliations, vendor follow-up, data processing, sample inventory review, and cross-functional coordination. When scaled across multiple studies, this can create multi-million-dollar portfolio efficiencies, strengthen operational agility, reduce burnout risk, and enhance timelines for data-driven decisions.

Future case studies may explore additional downstream benefits, including reductions in manual errors, improved cross-functional collaboration, and faster overall R&D cycle times.

Learn how Sample Intelligence could amplify work for your team.

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Selected References

Protocol complexity and data volume scale up from Phase 1 → 3 (drives workload).

Operational footprint expands with study size (sites, recruitment, duration). 

  • Nature’s analysis of 2,140 Phase III trials shows how large Phase III programs extend across more sites and recruit at slower per‑site rates—hallmarks of higher coordination and data/biomarker ops effort than earlier phases.

Roles that touch sample data are cross‑functional and scale with complexity.

  • EMA’s GCP Inspectors’ Reflection Paper on labs analyzing clinical‑trial samples details required controls around labeling, receipt, storage, chain of custody, validation, and data/IT—work that expands with sample throughput and vendor networks typical of later phases. [ema.europa.eu]
  • UKCRC guidance for Clinical Trial Units (CTUs) reinforces oversight and documentation expectations for labs and sample workflows under GCP—again indicating more moving parts = more effort.

Biospecimen management best practices formalize the non‑negotiable work (independent of ‘analytics’). 

  • NCI Best Practices for biospecimens and ISBER Best Practices for biorepositories enumerate the end‑to‑end activities—collection, processing, shipping, storage, tracking, QA/QC, data management—required to keep sample integrity and traceability; as counts/timepoints/vendors increase by phase, so do these activities.

Workload/acuity models from the field validate the need to budget FTE by complexity, not just headcount. 

  • ACRP’s peer‑reviewed article argues for complexity‑adjusted productivity models (beyond ‘patients per coordinator’)—the same rationale used to frame phase‑based FTE bands. [acrpnet.org]
  • SWOG (NCI network) and Mayo Clinic posters show practical workload sizing and CRC effort tools—evidence that programs estimate effort as protocol/site/sample complexity rises.

Analysis of screening, treatment and follow-up expenses, biological treatment per-patient costs can exceed $100,000. 

QuartzBio Business Value Case Study
QuartzBio Business Value Case Study

The challenge: sample management and inherent data issues

Managing clinical trial samples is complex. Samples move globally across sites, labs and biorepositories, creating costly delays from site errors, vendor issues, or data entry mistakes. Our customers were experiencing thousands of data issues per clinical trial, on average, and 75% were being missed by traditional reconciliation processes.

The solution: 360° Sample Intelligence

Powered by our Precision Medicine AI Agent Platform, QuartzBio’s Sample Intelligence™ solution provided a 360° view of every sample across their lifecycle, from collection to long-term storage. Our biomarker operations and biospecimen operations users received timely insights and course correction, ensuring data quality, compliance, and cost savings without adding headcount.

With QuartzBio, our customers were able to:

Save Time & Amplify Resources

  • Increase productivity by 2x
  • Focus teams on high-impact tasks
  • Achieve 10x faster time to insights

Avoid Mismanagement of Samples

  • Reduce out-of-protocol collections by up to 100%
  • Eliminate duplicate sample testing / sample waste
  • Improve collaboration

Avoid Protocol Deviations

  • Drive ICH E6(R3) compliance and reduce overall compliance risk
  • Accelerate access to high-quality data
  • Reduce human error

Ready to save $150,000+ per trial?

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The client: Clinical operations team at a mid-sized oncology biotechnology company. 

The clinical operations teams at a mid-sized oncology biotechnology company approached QuartzBio as they sought ways to close sample information gaps that would appear during reconciliation. 

Gaps in this process typically included the inability to report in a timely manner on: 

  • Missed collections 
  • Unexpected samples 
  • The status of samples and derivatives as they move onto third-party testing labs 

The challenge: The sponsor team lacked global visibility into their expected sample schedule across all collection sites. Too much time was spent on manual reconciliation, with delays of three months costing the client significant time and resources. 

In their existing reconciliation process, clinical operations leaders were often frustrated in their attempts to maintain robust global visibility. Generating reports was a time-consuming process that involved complex spreadsheets manually linking key information from the EDC, central labs, testing labs, and biorepositories to illuminate critical information like discrepancies or missed collections. 

Without global visibility, the client had trouble generating reports continuously throughout the life of a study. New data was often unavailable, vendor-specific nomenclature was frequently inconsistent, and data structures were sometimes incompatible. Consolidated insight across sample collection and processing status, consent status, and sample and derivative quality information was difficult to obtain. 

The solution: The sponsor team used QuartzBio’s Sample Intelligence Software-as-a-Service (SaaS) solution to systematically monitor and identify:  

  • Gaps in sample data  
  • Issues with sample shipments 
  • Data discrepancies 
  • Consent violations 
  • Subject exclusions 

The client’s clinical operations team worked with QuartzBio’s biospecimen operations experts and data engineers to deploy the Sample Intelligence solution and create a centralized, reliable source of sample information. This single solution closed the gaps that were hampering the reconciliation process. 

QuartzBio’s data ingestion and harmonization pipeline continuously integrated sample information from multiple sources. As this sample information was generated over the course of the study, the Sample Intelligence solution automatically performed edit checks and highlighted any data inconsistencies. For instance, teams could now see any direct reconciliation issues between the EDC and inventories at central labs, specialty labs, and biorepositories (Figure 1).

Automated Reconciliation vs EDC - QuartzBio

Figure 1. Automated sample reconciliation between EDC and other sample inventories enabled the clinical operations team to identify discrepancies between data that resides in any two source files (central lab vs. EDC, testing lab vs. EDC, and central lab vs. testing lab) and make timely corrections.

The outcome: Eliminating manual reconciliation processes with sponsor-centric visibility across the sample lifecycle 

Reconciliation efforts typically have large gaps in sample information that is critical for sponsor teams to maintain robust global visibility across all collection sites. Clinical data management traditionally reconciles the EDC from other points of view (e.g., adverse events, concomitant medications, patient history, RECIST response evaluation, investigational product guideline (IP) compliance, and many others). The QuartzBio Sample Intelligence solution functioned as an additional tool pulling information together from the EDC, each lab, and each biorepository. The solution also incorporated the sample schedule from the protocol, including changes to the protocol as new patients were enrolled and the protocol was amended.

With reconciliation gaps reduced and closed, clinical operations teams now had sponsor-centric visibility into sample status across the lifecycle of collections, processing, testing, and storage. With a single day of delay in getting a new product to market costing $1-$8 million in sales (source), the benefits of more effective sample and biomarker operations providing a holistic view of samples on-study cannot be understated.  

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THE CHALLENGE: OVERWHELMING COMPLEXITY

The client: large biotechnology company.

Clinical samples traverse a complex path. Whether the samples originate from sites halfway across the planet or across the street, clinical research teams are faced with the challenge of monitoring the status of biospecimens across multiple sites, labs, and repositories at multiple phases of development. Complex sample operations, disparate vendors, and inconsistent metadata across labs are common challenges sponsors face when keeping track of samples across clinical programs. ​

Complexity was the challenge one large biotechnology company faced as its clinical operations and translational science teams sought to track clinical samples across dozens of studies, dozens of specialty labs, and multiple central labs. The client previously used a custom-built, internally developed solution that enforced a rigid deployment approach and was unable to accommodate a variety of data types and data structures.

THE SOLUTION: QUARTZBIO® vSIM SOLUTION

When the client began to search for a new platform to replace its homegrown solution, QuartzBio’s virtual Sample Inventory Management solution (vSIM)​ presented itself as a more capable alternative solution. The client partnered with QuartzBio experts to ramp up quickly and provide immediate results.

  • The vSIM solution enabled the client’s teams to evaluate the status of samples on study and easily track consent, collection, and processing of samples. This made it easier to manage queries and identify discrepancies or patterns of non-compliance.
  • The client was able to start studies with new levels of speed and efficiency. Because the vSIM solution was “source-agnostic” in its approach to data collection, the client now had the flexibility to accommodate a variety of data types, formats, and structures. Ultimately, this range of seamless data consumption and integration enabled the client’s teams to identify sample availability by patient, assay, and other parameters. The client no longer had to devote time and resources to anticipate and set up a multitude of data pipelines. Instead, teams were able to utilize a library of configuration-ready application programming interfaces (APIs) as well as connectors and data processing pipelines. This enabled teams to visualize and review key pre-analytical data, detect patterns of site-based noncompliance, and identify data discrepancies early.
  • The client was able to build versatile portfolio-level dashboards and provide unprecedented visibility into key performance indicators (KPIs) such as missing samples, samples with expiring/expired stability or consent dates, lab turnaround times, sample testing status, and other operational metrics to drive on-study decision making.
  • Because the vSIM solution alerted the client to samples with imminently expiring consent and stability windows, the client was able to use over 500 samples before expiration to support current and planned studies.

Where sponsor teams previously lacked centralized visibility, they now possessed insight into the collection, processing, and storage status across multiple siloed source systems.

This powerful centralized visibility also had bottom-line ramifications on the client’s overall growth. Senior executives, including the CEO and CFO, were conducting serious discussions with another company that had identified it as a potential acquisition target and began auditing their inventory of valuable clinical biospecimens. Where requests for sample collection data had previously required extensive lead-time and resource allocation to perform, senior executive users now had real-time metrics at their fingertips to drive decision-making.

THE RESULTS: THE vSIM SOLUTION BECOMES THE “SINGLE SOURCE OF TRUTH”

QuartzBio’s vSIM solution quickly became a true game-changer for the client. By ingesting lab sample inventories, relevant electronic data capture (EDC extracts), sample manifests, electronic sample requisition forms (SRFs), and informed consent forms (ICFs), the client was ultimately able to create a virtual master sample inventory to track samples across every site, lab, and repository over their entire lifecycle. New growth opportunities emerged because vSIM powered a new level of flexibility and scalability to support everything from a single clinical program up to an entire portfolio of hundreds of studies across all phases of development – a single source of truth for all sample-related data.​

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QuartzBio Genomics Fileviewer
QuartzBio Genomics Fileviewer

The client: Biologics company developing cell therapies for blood cancers, generating large amounts of genomics data across four clinical programs and preclinical research teams

The client’s bioinformatics teams approached QuartzBio seeking a better workflow for sharing insights obtained from their genomics data.

They were using complex, manual workflows to ingest and process next-generation sequencing (NGS) data. These workflows comprised multiple steps, including alignment processing, variant processing, annotation, and clinical interpretation in the context of clinical data and publicly available data.

The challenge: Complex data management workflows hindered decision-making and created bottlenecks

The company had made a large financial investment in their data-rich therapeutic development programs – approximately $150M across the portfolio to date.

However, the complexity of their bioinformatics workflows made it difficult to share reports, analyses, and other visualizations with these stakeholders to get necessary signoffs and approvals.

Other specific concerns included

  • Data integrity
  • Data security and regulatory compliance
  • User access management – not possible with existing workflows

The solution: Centralized visibility across a wide user base with QuartzBio® Biomarker Intelligence (SaaS) solution

The client’s bioinformatics and translational medicine teams worked with QuartzBio’s genomics experts and data engineers to deploy the Biomarker Intelligence (BI) solution.

QuartzBio® BI, an enterprise SaaS solution, provided intuitive data query and topline reporting on data availability, enabling seamless data consumption across a wide user base. Bioinformatics teams were able to give stakeholders access to a centralized data vault where they could search, navigate, and explore all raw and processed data related to their genomics workflows (Figure 1).

Genomics file viewer QuartzBio eBDM solution
Figure 1. Genomics file preview capabilities within QuartzBio® enterprise Biomarker Data Management solution provided stakeholders with centralized visibility across all source files, harmonized datasets, and various configuration files associated with a bioinformatics project. Vaults were access-controlled, with permissions controllable by the client’s administrative users. Shown here is an example of the .bam file preview tool within the eBDM solution.

To address the client’s concerns around data integrity, the BI solution included automated checks for data integrity and conformity with data transfer agreements (DTAs), providing transparent quality control of incoming data. All data workflow processes were set up in the BI solution with secure, 21 CFR part 11-compliant audit trails.

The outcome: Streamlined stakeholder approvals + integration with internal workflows = faster decisions

Deploying the QuartzBio® BI solution automated processes for cleaning and harmonizing the client’s genomics data and centralized it within a single solution.

The solution was further integrated with internal client workflows via API capabilities and native R/Python support, shortening the time from data acquisition to insight generation.

Most importantly, the bioinformatics teams could streamline stakeholder approvals by using a solution with both data security and fine-grained user access management.

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The client: Biopharmaceutical company conducting phase I/II clinical studies 

The biomarker operations and clinical operations teams at a biopharmaceutical company approached QuartzBio as they sought ways to streamline biomarker sample operations in order to find synergies across their portfolio.

The biomarker operations team was responsible for tracking samples across a complex ecosystem of physical sample locations and sample data streams:

  • 19 clinical trials across 5 therapeutic areas
  • 60 different vendors handling samples over the course of the biospecimen lifecycles
  • 6-8 vendors per study

The challenge: Time and resources spent chasing sample status information for ad hoc requests  

Spending over $1M annually across the portfolio for biospecimen shipping and logistics, the client nevertheless faced challenges in understanding where their samples were at any given time.

Whenever there were discrepancies, such as missing samples, samples not collected, or missing data, it was the biomarker and clinical operations teams’ task to find the samples, or at least, the reason for the discrepancies.

The team voiced multiple frustrations, such as:

  • “When we realize too late that there’s an issue with the sample inventory, reconciliation can be a rushed, manual process.”
  • “We’re unable to see sample data all in one place, vendors collect and report data differently, and it’s hard for them to change.”
  • “Our teams spend so much time on manual tracking and ad hoc reports, we don’t have bandwidth to analyze the big picture or to make important, patient-centric improvements that would have a real impact on the getting therapies to patients faster.”

The solution: Tracking samples with QuartzBio® Sample Intelligence Software-as-a-Service (SaaS) solution

The client’s biomarker operations team worked with QuartzBio’s biospecimen experts and data engineers to deploy the Sample Intelligence (SI) solution, which began delivering value just 4 weeks after kickoff.

This enterprise SaaS solution provided a master sample inventory that enabled the client to track all parent samples and derivatives — a single interactive hub for browsing, visualizing, and downloading harmonized sample data (Figure 1). All data, whether extracted from the electronic data capture (EDC) system or from other inventories, was systematically mapped to a common data dictionary using QuartzBio’s robust, scalable data ingestion pipelines.

Figure 1. The SI solution’s master sample inventory provides a roadmap of where a sample has been in its journey from collection to testing to storage. Each row of the master sample inventory represents a sample or a derivative aliquot of that sample. Columns contain all information associated with a particular sample, such as collection dates, time points, subject identifiers, testing status, accession information, and more.

The outcome: Eliminated manual tracking, reduced time spent generating status reports

Since deploying the QuartzBio® SI solution, the client’s biomarker operations and clinical operations teams have been able to eliminate all manual sample tracking processes from their workflow. Because the teams now spend 75% less time generating sample status reports than they spent before, they have been freed to focus on higher value tasks and pursue strategic initiatives, such as optimizing data generation plans and site training.

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Biomarker Intelligence Data Ingestion Harmonization QC Analysis - QuartzBio
Biomarker Intelligence Data Ingestion Harmonization QC Analysis - QuartzBio

The client: Clinical development and translational research teams executing phase I and II studies for precision oncology 

A clinical-stage biotechnology company developing precision oncology therapeutics recently worked with QuartzBio to tackle challenges facing execution of three phase I and two phase II biomarker-informed studies.

Challenges facing clinical development included:

  • Limited pool of potential patients to recruit for studies
  • Challenges facing patient screening and stratification – ideal biomarker profile not well-defined

Specific challenge: integrating siloed data

The clinical development team was challenged to solve the problems of patient qualification and stratification by integrating data from multiple streams, across multiple clinical programs:

  • Electronic medical records
  • Lab data
  • Biomarker profiling with indication data for patients
  • Immune profiling data
  • Publicly available data
  • Preclinical data: cell data and animal (cytokine and biomarker) data

The data sets being generated as a result of the clients’ clinical programs were scattered across multiple, disconnected cloud storage solutions. The team needed data to be integrated in a unified, query-friendly database that complied with regulatory requirements.

The solution: QuartzBio’s Biomarker Intelligence Software-as-a-Service (SaaS) Solution

The client’s clinical development team worked with QuartzBio’s informatics subject matter experts and data engineers to deploy the Biomarker Intelligence solution within weeks.

The solution enabled scalable, user-driven data management of the client’s entire ecosystem of biological data (Figure 1).

Figure 1. Overview of the Biomarker Intelligence solution as deployed across 5 clinical studies. Multiple data types were automatically loaded into the Precision Medicine Platform via various integration channels as required. After indexing, quality control (QC), and mapping in the landing, ingestion, and configuration layers of the Precision Medicine Platform, client teams could interrogate the data ecosystem using both the web interface and API access.

Because QuartzBio’s data platform is data type-, data source-, and vendor-agnostic, every one of the clients’ data streams could be acquired, ingested, quality-controlled, and harmonized within the platform.

  • Data type-specific templates were used to automatically harmonize and annotate data from different vendors at the time of or after data import
  • QuartzBio’s library of configuration-ready workflows spanned all assay technologies used by the client: genomics, high-content imaging, flow cytometry, immunohistochemistry

The outcome: freedom to explore and transform data via web-based UI

Once data was set up within the platform, users had the freedom to explore and transform data via a web-based user interface (UI) with data access controls, version history and audit trails.

The Biomarker Intelligence solution enabled collaboration among a diverse user base across the client’s organization. Not only did the clinical development team uncover insights to inform trial execution, but the clients’ bioinformatics, translational biology, and biomarker operations teams also used QuartzBio’s visualization, data analysis, and top-line reporting capabilities as follows:

Functional TeamHow the team used enterprise Biomarker Data Management
Biomarker OperationsOn-study reporting of data quality, data conformity, data availability, vendor performance, and turnaround times.
Data Integration, QC, and Validation
Bioinformatics / Computational BiologyGenerated visualizations (e.g., line plots, clustering, dimensionality reduction) and were able to connect data to existing tools (e.g., SpotFire, Prism)
Connect to Raw Data and Download Data
Translational ResearchObtained early insights into the ideal genomic profile of patients that showed response to the therapeutic candidate.
Genomic Profiling

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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 virtual Sample Inventory Management solution, powered by the QuartzBio® Data 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 virtual Sample Inventory Management 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 QuartzBio Data Platform 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-clinical-KPIs
translational-KPI-dashboard
Figure 1. Clinical Site Sample Collection Performance Dashboard. Using this and other clinical KPI dashboards on the QuartzBio Data Platform, the client could evaluate vendor and site performance within and across studies.

Watch our webinar, “Biomarker Operations KPIs,” to see these dashboards in action, as well as the latest reporting capabilities available to users of QuartzBio’s vSIM solution.

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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

Explore Biomarker Data Management

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?

Explore virtual Sample Inventory Management

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