Biomarker Operations Archives - Page 2 of 4

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!

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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 Caitlin Cook, QuartzBio’s Director, Customer Success. After learning about Caitlin here, please feel free to connect with her on LinkedIn.

In your own words, what do you do?
Modern drug development is a collaborative process involving a multitude of stakeholders – from scientists and researchers to data analysts and regulatory professionals. My team’s role is to foster and maintain strong, trust-based relationships between our company and our clients while also encouraging collaboration among all those various teams. In essence, we’re the glue that binds these elements together and ensures that the exchange of knowledge, expertise, and data flows seamlessly.

As the Director of Customer Success, my mission is crystal clear: to empower our clients with the knowledge, tools, and support they need to thrive in an increasingly data-driven world. This role is at the intersection of technology and human connection, bridging the gap between innovation and its real-world impact. My team and I provide solutions to help pharmaceutical and biotechnology companies accelerate the development of new treatments for the patients that need them. We encourage our customers to think differently about the way they currently approach sample and biomarker data management.

One of the most exciting aspects of my work is the opportunity to guide our clients through the dynamic and ever-evolving realm of data management. We work hand in hand with pharmaceutical companies to design custom solutions that align perfectly with their needs. This journey involves identifying challenges, setting clear objectives, and creating a roadmap to success.
What is your fondest memory of working at QuartzBio?
I was fortunate enough to be part of an amazing milestone for QuartzBio: our inaugural User Summit in November 2022. The Summit was a testament to the strength of community, shared vision, and commitment to the advancement of clinical biomarker sample and data operations management.

The challenges in the industry are manifold, and we wanted to hear directly from our clients to understand their unique perspectives. As Clinical Biomarker Sample and Data Operations Managers, they are the unsung heroes navigating a complex ecosystem. Common industry challenges echoed loudly, and the Summit included discussions around data integration, data quality, and the need for more efficient and scalable solutions.

The discussion at the Summit validated the need for a reliable partner to alleviate these burdens. It provided a platform for our clients to voice their current challenges, but more importantly, it served as a catalyst for solutions. The main takeaways from our clients were both inspiring and invigorating. The clear message I took away from our time together was that our products are pivotal in lessening the manual labor that often leads to resource burnout and attrition. By providing the right tools to do their jobs, we’re contributing to a healthier, more sustainable work environment. We empower our clients to define success within their organizations by providing data that contributes directly to the creation of Key Performance Indicators (KPIs). This alignment between our technology and their vision is a driving force behind their success. The resonance between our company culture and our clients is a testament to the mutual commitment to progress and innovation.

We’re not just partners; we’re collaborators in a shared journey. Our clients value us for our efficiency and flexibility. In an industry marked by constant change, these attributes ensure our solutions evolve with them.

I couldn’t help but be excited about the future. After attending that event and talking with our clients, I knew I made the right choice to join the QuartzBio leadership team.
Complete this sentence: QuartzBio is _________ because _________.
QuartzBio is pioneering because of our innovative and groundbreaking role in the field of biomarker data platforms.

Describing QuartzBio as ‘pioneering’ captures the company’s commitment to both push the boundaries of what is possible and lead the way in a field that is critical for the future of healthcare and clinical research.
Complete this sentence: QuartzBio customers are _________ because _________.
QuartzBio customers are resilient and creative because they are caring and innovative.
What piece of art – book, movie, music, artwork, etc. – inspired you the most and why?
Living in Atlanta, Georgia for more than 10 years has given me insights and fresh perspectives to a melting pot of creativity. I spent much of my time during the pandemic quarantined in the north-end of the city where violent riots, looting, and vandalism destroyed most of the shops in the area. In one shop, though, there was a sculpture of a silver woman standing resilient and untouched. This metal composite figure turned out to be the work of Martin Dawe, a sculptor famous to local Atlantans for his giant historical pieces around the city such as the World Athletes Monument and the Dr. Martin Luther King Jr. monument.

The silver woman, also known as ‘Repose’, inspired me and is in my home today. She is a testament of strength and grace, and a reminder to me to be unwavering in how I show up in the world every day.
What’s the best piece of advice you have ever been given?
“Every day for the rest of your life you will find yourself at one of three phases: aspiration, success, failure. You will battle ego in each of them. You will make mistakes in each of them. You must sweep the floor every minute of every day. And then sweep again.” – Ryan Holiday

My interpretation: The work to improve never stops. You can sweep your floors and yet they are dirty again tomorrow. Effort isn’t a one-time thing. You must commit to yourself and others each day, over and over again.

Connect with Caitlin on LinkedIn

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.

Register Now >>

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

AI/ML can be a powerful, error-reducing tool for managing clinical sample data as well as biomarker data.

AI/ML-based tools should not replace human judgment, particularly for insight generation, at least until AI/ML-based tools are extensively and rigorously validated (as any piece of critical software would be). Furthermore, regulatory compliance and data privacy are of utmost importance and must be considered when building and using solutions that leverage generative AI frameworks.

However, near-term applications of AI/ML can dramatically improve any tedious process involving a human inspecting data. We list some of these processes in the box below, along with steps we recommend taking to reduce risk in each case.

Register to watch on demand:

Complex sample operations, disparate vendors, inconsistent metadata across labs are common challenges sponsors face when keeping track of samples across clinical programs.

Join our webinar to learn how sponsor teams are creating consistent, portfolio-level approaches for tracking sample status and location and uncovering insights into vendor/site/country-level performance.

The Challenge: Siloed, Uncodified ICF Data

The challenge many sponsors face is not one of quantity. Instead, it is one of complexity. Sponsors may have many thousands of biospecimens from many different clinical trials sitting in multiple long-term storage locations, each having varying ICFs and sample destruction dates. This makes it difficult for clinical teams to address questions such as

“Which FFPE samples in Biorepositories A, B, and C are consented for genomic analysis?”
“Which samples will be destroyed within the next 6 months per sample destruction date listed on the ICF?”
“Which samples need to be destroyed because the subject has withdrawn consent?”

The Approach: Tailored, Sponsor-Centric ICF Codification

The ideal virtual biorepository is a searchable master inventory of the vast array of samples from both open and closed clinical trials. With this much data on hand, R&D teams must be able to search and filter that inventory based on consent data fields such as:

Consent status – including withdrawal of consent
Consent restrictions and approved uses
Sample destruction date based on ICF linked to sample type
Links between multiple different ICFs (for example, a master ICF, future-use ICF, and a genomics ICF for subset of samples) at patient, site and country levels

In addition to these critical types of consent data, QuartzBio clients often seek to interrogate and visualize ICF data to suit specific applications. For example, a client may wish to explore codified ICF data linked to appropriate sample type, with parent/child linkages, filterable to find samples of interest, annotated with approved and restricted use cases.

By linking biospecimen metadata, informed consent, and biomarker data across multiple laboratory LIMS and inventories, clients can create a flexible virtual biorepository that is ready to use for a wide range of R&D needs.

The Results: More Codified Consent Data, More Power

Armed with a master inventory annotated with codified informed consent data, clinical and translational teams are empowered to

Save resources and time, using stored samples to advance research beyond this current study
Rapidly respond to requests for additional testing
Ensure regulatory compliance with retention, use, and destruction requirements based on informed consent
Facilitate efficient discontinuation or transfer of studies/programs
Perform risk-based monitoring to determine, at a distance, whether every sample has an appropriate consent status

At QuartzBio, we deliver solutions that advance our clients’ pipelines today while remaining future-proof for tomorrow. This resilient approach is critical, especially in the face of evolving scales, regulatory requirements, and complexity of clinical programs.

QuartzBio is rigorous with regards to regulatory compliance, yet flexible to sponsors requirements, both in terms of which information to extract as well as how to visualize, filter, and search it.

Some sample inventory management systems are limited as to which data structures can be imported, or even place data structure requirements on vendors. QuartzBio technology maps data as-is, from any source, into the QuartzBio® Data Platform using the format provided by the lab, vendor, or other source system with no changes required. The result: increased flexibility and faster deployment.

Further, while some ICF codification solutions limit users to filter using 7-9 rigid terms, QuartzBio’s virtual Biorepository solution enables clients to configure the platform to enable filtering, searching, and visualizations using sponsor-defined parameters.

How is your team thinking about making the most of your biospecimens? Connect with the QuartzBio team to discuss the structure your consent data and get a closer look at the QuartzBio data platform.

Contact Us to Continue the Conversation

4 Strategic Imperatives for Clinical & 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.

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.

Register Now >>

About the presenter:

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

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 — 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.

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.

Sign up for 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.

Register for the Webinar