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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

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

Duration: 30 minutes

Sign up to watch the webinar on demand:

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’s team has deep experience in technology-enabled solutions for the life science industry. In this blog series, we invited you to get to know a member of the QuartzBio team.

This month, we are delighted to talk with Katie Berola, Director of virtual Sample Inventory Management. After learning about Katie here, please feel free to connect with her on LinkedIn.

In your own words, what do you do?
I build tools that take a process that is necessary and time-consuming and make it better and faster.

Subjects in clinical trials are volunteers. Some patients consent without knowing if the treatment will help them. Others consent knowing the treatment will likely not help them, but they volunteer anyway. At the end of the trial, the samples and the data are all that is left. Building tools to take all that knowledge gained, even in failure, and make it useful for the future is a part of respecting the patients’ sacrifice. For some patients, that sacrifice can be precious hours in the last weeks and months of their lives.

I am passionate about data quality, making research better, and helping patients have better outcomes.
What is your fondest memory of working at QuartzBio?
My fondest memory was when I came to this company and realized they encourage innovation and creativity.

The priority to deliver our clients’ expectations is high, but equally high is the expectation to continuously improve and develop our tools. It is inspirational to know that if improvement is possible, I will be encouraged to pursue that improvement even if a different method already exists.
Complete this sentence: QuartzBio is _________ because _________.
QuartzBio is cutting-edge because we do not stop creating solutions. The team here faces new challenges frequently and strives to solve them.
Complete this sentence: QuartzBio customers are _________ because _________.
QuartzBio customers are an opportunity to enhance or expand our tools because there are always new challenges and different needs. Some of the best product features we have developed originated from QuartzBio customers, and those features have then been used to benefit all customers.
What piece of art – book, movie, music, artwork, etc. – inspired you the most and why?
It was very hard to choose as I am inspired by many things!

My favorite example is the Lord of the Rings trilogy. Taking what is one of the best fantasy stories ever written and blending artistry and technology to bring it to life is truly amazing. It’s a beautiful combination of human creativity and scientific advancement.
What’s the best piece of advice you have ever been given?
There are ten solutions to every problem. The first solution, while functional, may not be elegant. It is our responsibility to keep working to find the other nine solutions to achieve both functionality and elegance.

Connect with Katie on LinkedIn

In a recent article titled, “The Criticality of Specimen Management to Precision Medicine,” Brenda Yanak warned drug developers against minimizing the importance of biospecimens, so often overlooked during biomarker development.

Dr. Yanak is known in the Biospecimen and Biomarker Operations field for her transformative work in translating scientific strategy into clinical operations, via technology and innovation, across both biopharma and central labs. Her efforts have succeeded in drawing attention to biospecimens, which are central to diagnosis and treatment.

However, as she points out in this article, transparency in biospecimen chain of custody is frequently lacking, with responsibilities split among multiple organizations, leading to unclear processes, extended timelines, and inefficiencies.

Dr. Yanak’s article highlighted both challenges of current processes and specific ways to improve biospecimen management:

Challenges Present in Traditional Biospecimen Operations:

Roles and responsibilities among various teams, both internal and external, are often unclear.
Lack of transparency in biospecimen chain of custody contributes to extended clinical trial timelines.
Manual tracking using Excel spreadsheets is common, leading to inefficiencies and potential errors.

Improving Biospecimen Management:

There is a need for Quality Management System (QMS)-level specimen management processes.
Technology solutions, such as QuartzBio’s virtual Sample Inventory Management (vSIM) solution, can streamline biospecimen management.
Minimize manual tasks for fewer errors and increased speed.
Standardization and collaboration are proposed to accelerate biomarker research and clinical trials in the precision medicine era.

Read the full article on LinkedIn!

Read Article

Duration: 30 minutes

Register to Join the Webinar:

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.

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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.

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About the presenter:

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

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.

Register for the Webinar

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.

Key Takeaways from SCOPE Summit for Clinical Operations Executives

Sponsor teams need faster answers from disconnected data streams.

How is the current system holding businesses back?

Generative AI overcomes data challenges

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

QuartzBio Precision Medicine AI Agent Platform

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

Sign up to watch the webinar on demand:

Watch the Webinar >>

Challenges Present in Traditional Biospecimen Operations:

Improving Biospecimen Management:

Register to Join the Webinar:

Summary:

Register Now >>

Register to Watch On Demand:

Summary

Register Now >>

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

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