Tell me what I don't know - SCOPE 2024 recap - QuartzBio
Tell me what I don't know - SCOPE 2024 recap - QuartzBio

Key Takeaways from SCOPE Summit for Clinical Operations Executives

Tobi Guennel, PhD, QuartzBio’s Senior Vice President of Product & Chief Architect, energized the Biomarkers & Precision Medicine track at the SCOPE Summit for Clinical Operations Executives by showing how generative AI can address challenges faced biospecimen and biomarker operations teams, as well as clinical and translational teams, when gathering insights on samples across all parts of a complex biomarker data ecosystem.

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Sponsor teams need faster answers from disconnected data streams.

Sponsor teams want more clarity. The current chaotic state of biospecimen management hinders speedy decision-making. Because of the influx of specimen (and their associated data) coming from hundreds of varied locations (in just as many varied formats), teams can feel overwhelmed with the sheer volume of information to manage.

“What’s the status of today’s shipments?” “Where is this sample’s location?” “How is Site 53’s sample collection performance?” “What’s the current turnaround time for genetic testing?”

How is the current system holding businesses back? 

Quality data is the foundation of precision medicine but most of this critical data is siloed, inconsistent, and inaccessible. In fact, half of all translational scientists in our industry struggle to access the insights they need to complete their work effectively. Further, many of these scientists report only 60% confidence in the accuracy of this data when manual data entry is considered, and the revenue loss due to data ecosystem challenges is over $31B annually. But, for the companies who can overcome these data and technology ecosystem challenges, the reward is great: these companies are 23x more likely to be profitable than those who cannot.

Generative AI overcomes data challenges

As discussed at the SCOPE Day 1 plenary panel on generative AI, there is now broad awareness of the potential for AI to accelerate drug development. Specifically, we heard how AI is already enabling universal data structuring, harnessing large language models to tackle clinical research tasks, and integrating multimodal data.

Generative AI empowers drug development teams to overcome data and technology ecosystem challenges because it can automate data management tasks and break down data silos, helping businesses gain a holistic view of their operations, and free teams to make more informed decisions, faster. Instead of requiring an extensive understanding of coding and statistical modeling, generative AI now allows users to ask requests in plain language. Ask a question, get an answer.

Generative AI applied to both data management AND business intelligence drives precision medicine at scale

With the Precision Medicine AI Agent Platform, QuartzBio is giving sponsors a smart and scalable platform for deploying generative AI to enhance decision-making throughout the precision medicine R&D lifecycle. This platform is built on a foundation of high-quality data, because insights mean nothing if you don’t first ensure quality data. QuartzBio’s AI-powered data management tools are tailor-made to streamline data ingestion, QC, and mapping for drug development workflows, helping to improve data quality and reduce errors by leveraging automation to surface data issues to stakeholders.

Layered on these data management tools, the platform contains a suite of business intelligence tools that we call biomarker intelligence tools because they were purpose-built to address the challenges in biomarker-guided drug development. These tools are designed by subject matter experts to improve business agility through data exploration, dashboards, analytics, and reporting.

QuartzBio Precision Medicine AI Agent Platform

Leveraging AI across the platform makes our data management and business intelligence tools smarter, easier to use and more efficient to configure. To create a true force amplifier and decision accelerator, we’ve built our Agent Intelligence Solution, powered by our Precision Medicine Virtual Assistant. This assistant transforms the way users interact with our platform to shorten the time from having a question to receiving easily consumable information. The Virtual Assistant is your personal guide through our Precision Medicine AI Agent Platform, allowing you to quickly navigate to the right tool and streamline your data management and business intelligence.

The presentation highlighted four common use cases of the AI Virtual Assistant as applied to QuartzBio’s Sample Intelligence Solution:

  • Sample monitoring for collection, testing, shipping and storage
  • Monitoring vendor performance
  • Tracking clinical trial site performance
  • Monitoring query trends in real time and surfacing root causes
QuartzBio Taming Sample Chaos Webinar Featured Image
QuartzBio Taming Sample Chaos Webinar Featured Image

Talk to your data to get fast answers across the entire sample lifecycle​

Duration: 30 minutes

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What you’ll learn:

Every day, you are pressed to make decisions based on chaotic, disconnected flows of biospecimen status and consent information. ​

Learn how conversational AI enables you to talk to your biospecimen data. Ask a question, get an answer, and begin your journey from chaos to insight across the entire biospecimen lifecycle.​

Join Bill Hall for a demo of our Sample Intelligence solution, powered by our Precision Medicine AI Agent Platform and enhanced with the new Agent Intelligence solution:

  • Access, interrogate, and conversationally derive valuable insights from sample data across clinical trials​
  • Proactively surface discrepancies and act on trends as they emerge​
  • Gain insights into vendor and site performance​
  • Get answers in seconds on status of sample shipments, testing, stability and expiration

Bill will be chatting with the QuartzBio Virtual Assistant, the intuitive new guide to the QuartzBio platform!

Who should attend:

  • Biomarker and Biospecimen Operations
  • Clinical Operations
  • Translational Researchers
  • Biosample Management Teams

Watch the Webinar >>

QuartzBio Webinar_Unify Clinical Biomarker Data
QuartzBio Webinar_Unify Clinical Biomarker Data

Explore patient biomarker profiles across assays and vendors with a single solution

Duration: 30 minutes

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What you’ll learn:

Biomarkers, when used to guide clinical programs, could mean the difference between success and failure. 

But exploratory biomarker data can be a headache to manage. Translational and data science teams struggle with disconnected data flows from specialty labs, sponsor data processing pipelines, and clinical data stores.

Join Bill Hall for a webinar demo of the QuartzBio® Biomarker Intelligence (enterprise Biomarker Data Management) solution. 

We’ll show you how to

  • Generate patient profiles to view tumor burden over course of treatment
  • Explore multi-marker views of patient profiles
  • Review ancillary data (e.g. images)
  • Evaluate patient profiles on a cohort level
  • Cross-reference biomarker measures across file types; e.g., compare ctDNA profiles of interest with clinical efficacy biomarkers such as immunohistochemistry

Who should attend: Translational Research teams, Biomarker Operations teams, Clinical/Biomarker Data Science teams, Clinical Development teams, Bioinformatics and Computational Biology teams, Office of the CIO/CTO, Data Management teams

Watch Now >>

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!

QuartzBio Connecting Raw Processed and Ancillary Data
QuartzBio Connecting Raw Processed and Ancillary Data

Translational and clinical teams spend more than 70% of their time managing, cleaning, and harmonizing data generated in biomarker-rich clinical programs.

In a webinar now available on demand, we demonstrated how the QuartzBio® Biomarker Intelligence solution addresses one set of frequently intractable challenges: connecting raw, processed, and ancillary data across multiple clinical studies.

We invite you to sign up for on-demand access to the recorded webinar.

Multiple Assay Modalities, File Types, Data Storage Locations

As we have previously described, research teams are generating biomarker data from a wide variety of assay modalities, and this data can be housed in multiple, disconnected storage locations. In the example use case described in the webinar, data was being generated from targeted assays like flow cytometry and immunohistochemistry to high-throughput omics assays.

QuartzBio’s solution is specifically engineered to ingest, standardize, visualize, and analyze this data. The unified data platform connects raw and processed data to ancillary files, such as the images used for immunohistochemistry quantification or PDF omics reports. All of the raw files are available for download individually or in bulk. They can also be previewed directly within the user interface.

As shown in Video 1, the QuartzBio enterprise data platform can centralize and harmonize data from multiple file types across clinical programs, including:

  • Image files
  • Tabular files
  • Omics files, e.g., BAM or VCF files
  • Sequencing reports for particular mutations or genomic regions of interest
Video 1 (Click image to view video): The enterprise data platform can centralize and harmonize data from multiple file types across clinical programs. Video demonstrates access to images, PDF files, and genomics data.

As shown in Video 2, QuartzBio’s solution can combine processed files with harmonized clinical annotations, with both subject and sample level data, as well as the relevant quantified reportables for a specific assay modality. These reportables are very configurable and can be changed according to the needs of a sponsor, a program, or even a specific study.

Video 2 (Click image to view video): Processed files combine harmonized clinical annotations with both subject- and sample-level data.

The QuartzBio platform can also further preprocess raw assay data directly and apply quality control metrics as well as normalization techniques.

In summary, the webinar demonstrated how the biomarker data modules of the QuartzBio platform can enable easy access to both key raw and processed data assets through the user interface, in addition to robust visualization and data exploration capabilities.

Flexible Biomarker Data Management Means Faster Deployment

QuartzBio’s enterprise-grade Biomarker Intelligence provides a flexible, scalable solution for transforming biomarker data into consumable information across a sponsor’s entire study portfolio.

This resilient approach is enabled by a robust enterprise data platform with a library of pre-built, configuration-ready pipelines for data ingestion.

Contact us to learn more about data management SaaS solutions and let us know which additional features and capabilities you’d like featured in our next webinar.

Contact Us to Continue the Conversation
Monitoring Vendor Performance Webinar
Monitoring Vendor Performance Webinar

Duration: 30 minutes

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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.

Register Now >>

About the presenter:

QuartzBio, part of Precision for Medicine, delivers software-as-a-service (SaaS) solutions to accelerate drug development.

Critical On-study biomarker KPIs - QuartzBio Webinar
Critical On-study biomarker KPIs - QuartzBio Webinar

Watch on Demand: Integrating Data Silos to Unlock Scientific Insights and Empower Translational Teams

Duration: 45 minutes

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You will learn how to:

  • Expand your use of exploratory biomarker data in combination with clinical metadata for on-study analytics
  • Centralize integrated biomarker and clinical data as a single source of truth to expedite drug development decisions and enable translational exploration
  • Leverage dashboards to support collaboration and quickly surface actionable insights

Abstract of the Webinar

Today’s clinical trials have global footprints to reach targeted patient populations and rely on specialty labs running complex assays to assess safety, characterize patient response, and provide insight into efficacy.

These biomarker-centric programs demand a focused strategy to provide timely visibility into sample availability and quality, data availability and quality, and critical on-study measurements.

Much of the information necessary to deliver biomarker intelligence exists today – though it is dispersed across workstreams (e.g. sample, assay, clinical, consent) and stakeholders (e.g. CROs, sites, labs, sponsors) and systems (e.g. EDC, CTMS, LIMS).

Just as EDC adoption accelerated the centralization of clinical data, our team will highlight the opportunity to integrate and centralize biomarker data, the unique challenges that have historically faced the industry, and how overcoming these challenges can unlock transformative insights.

In this on-demand webinar, “Critical On-Study Biomarker KPIs for Modern Trials: Integrating Data Silos to Unlock Scientific Insights and Empower Translational Teams,” we will discuss the opportunity to expand the use of exploratory data for on-study insights. Topics to be covered include:

  • Centralizing integrated biomarker and clinical data as a single source of truth to enable insights into PK/PD effects as well as translational exploration
  • Leveraging dashboards to support collaboration and quickly surface actionable insights

Throughout the discussions, our team will highlight how smart technology, consisting of sophisticated connectors and scalable data workflows, enables the rapid assimilation and synthesis of historically disparate data. This use of technology enables insights today – rather than as the product of years long enterprise investments – and reduces the burden, frustrations, and delays associated with manual data reconciliation and a patchwork of homegrown solutions.

Watch the Webinar
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Precision for Medicine is the first biomarker-driven clinical development organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments. Precision for Medicine is part of Precision Medicine Group, with 3,000 employees in 40 locations.

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