QuartzBio at SCOPE 2024
QuartzBio at SCOPE 2024

February 11-14, 2024 | Orlando, FL, USA

Curious if an AI-enabled solution is right for your clinical sample management? At this year’s SCOPE (Summit for Clinical Operations Executives) conference we’ll be presenting:

“Tell me what I don’t know: AI-enhanced decisions in biomarker-informed trials”
12:20 PM, Monday February 12, Operationalizing Biomarker & Precision Medicine Trials track

where you’ll learn about deploying generative AI in drug development.

We’ll demonstrate how conversational AI empowers users to extract insights from sample and biomarker information. Additionally, we’ll discuss how predictive features of GAI may enable novel insights by proactively surfacing information instead of passively waiting for input.

QB_Meet Katie Berola_11212023_V1
QB_Meet Katie Berola_11212023_V1

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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.
Brenda Yanak -- Biospecimens
Brenda Yanak -- Biospecimens

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!

QuartzBio enterprise Biomarker Data Management webinar Sept 2023
QuartzBio enterprise Biomarker Data Management webinar Sept 2023

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

Duration: 30 minutes

Sign up to watch the webinar:

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® 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 >>

QuartzBio Digitizing Biomarker Operations webinar June 2023
QuartzBio Digitizing Biomarker Operations webinar June 2023

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 processes in drug development by QuartzBio 202305
AI-ML processes in drug development by QuartzBio 202305

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.

QuartzBio SolveBio PR Social Image 20230123
QuartzBio SolveBio PR Social Image 20230123

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning, and R&D productivity.

Frederick, MD – January 24, 2023 Precision for Medicine, the first global, precision medicine clinical research services organization, today announced the strategic acquisition of SolveBio by QuartzBio.

SolveBio’s intelligent technologies and enterprise data management platform has integrated into QuartzBio’s suite of SaaS solutions, providing a single, scalable solution supporting clinical sample inventory management and biomarker data management for the biotech and pharmaceutical sectors.

The combined offerings under QuartzBio provide scientific and operations teams in drug development with an agile, user-friendly data management platform that enables enterprise-level visibility across the lifecycle of their sample and biomarker data.  Leveraging this expanded enterprise suite of solutions, scientists in translational research and clinical operations can more easily collaborate across functions, analyze and report on key datasets, and generate insights.

“We are excited to have SolveBio joining forces with QuartzBio,” says Scott Marshall, Ph.D., General Manager of QuartzBio. “As our industry continues to innovate, it is imperative that we continue to advance our portfolio of enterprise solutions to enable scale and connectivity in support of our ultimate goal – delivering therapies to patients. Integrating SolveBio’s technology with QuartzBio’s existing portfolio helps us accomplish that.”

QuartzBio’s fully connected, end-to-end SaaS solutions are engineered to enable seamless monitoring and tracking of clinical sample status, informed consent form (ICF) tracking/codification, and management of biomarker data across the enterprise, resulting in a unified solution for the management and delivery of both samples and their related biomarker data.  The platform is used to generate scientific and operational insights, while studies are in progress, after studies are complete, and across multiple clinical programs.

Combining the QuartzBio and SolveBio teams’ expertise and scale, QuartzBio can now better support clients’ strategic goals and day-to-day productivity by helping clinical and translational teams:

  • Save time with technology that maps data as-is, from any source, using the format provided by the lab, vendor, or other source systems with no changes required—increasing flexibility and speeding deployment.
  • Gain visibility into sample status with virtual Sample Inventory Management, a single source of truth linking samples and derivatives with clinical data, informed consent, shipping status, and more – across multiple sites, labs, and repositories.
  • Increase efficiency and reporting accuracy with enterprise-wide Biomarker Data Management, as all sample-related data will be centralized and harmonized in a unified data platform, thus eliminating the need to search for data in multiple storage locations.
  • Consolidate visibility to stored samples from all studies (active and inactive) with virtual Biorepository, across geographies, biorepositories, and central labs (long-term storage) to facilitate planning for future data generation.
  • Collaborate and connect by leveraging biomarker-specific visualizations (e.g., genomic and flow data modules), shareable dashboards, internal and external notifications, and application programming interfaces (APIs)/connectors that allow the QuartzBio solutions to empower decision making in the context of a complex data ecosystem.

“We’re very excited to join Precision for Medicine and become a part of QuartzBio,” says Mark Kaganovich, SolveBio’s Co-Founder and CEO. “It’s a big opportunity to continue improving our offering to our customers.” “QuartzBio’s acquisition of SolveBio is a major step forward in our goal to solve biomarker data management for the pharmaceutical and biotech industry,” says David Caplan, SolveBio’s Co-Founder and CTO. “By joining QuartzBio’s amazing team, we will be able to provide the comprehensive solution our clients need to get precision treatments out to patients faster. We are honored to be a part of this journey.”

About Precision for Medicine

Precision for Medicine is the first biomarker-driven clinical research services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Precision applies novel biomarker approaches to clinical research that integrate clinical trial design and execution with deep scientific knowledge, laboratory expertise and advanced data sciences. This convergence of trials, labs and data sciences is driving faster clinical development and approval. Precision for Medicine is part of Precision Medicine Group, with 3,200 people in 40 locations in the U.S., Canada, Europe and Australia. For more information, visit PrecisionForMedicine.com.

About QuartzBio

QuartzBio helps overcome the data chaos inherent in modern drug development. We serve clinical operations and translational research teams in oncology, autoimmune, CNS and other biomarker-rich therapeutic areas, whose progress hinges on navigating and connecting a complex data ecosystem. Our suite of fully connected, end-to-end SaaS solutions is engineered specifically to address the challenges of both sample data and biomarker data management – providing a single, scalable data platform solution to the biotech and pharma sectors. For more information, visit Quartzbio.com.

About SolveBio 

SolveBio is an industry leader in advanced precision medicine data analytics. Its technology platform enables biopharma customers to lower trial risk, create more effective therapeutics, and compress the time scale of clinical development. The core of SolveBio’s platform is technology to connect genomic data that comes from a rapidly compounding complex landscape of vendors, studies, and patients.

Media Contact

Ann Smith
Precision Medicine Group Media Relations
201-680-9447
asmith@coynepr.com

20230201 vSIM Webinar QuartzBio Clinical Sample Chaos On Demand
20230201 vSIM Webinar QuartzBio Clinical Sample Chaos On Demand

Duration: 30 minutes

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.

Read more

October 31, 2022 – Translational and clinical teams spend more than 70% of their time managing, cleaning, and harmonizing data generated in biomarker-rich clinical programs.

In a recent webinar, Adam Brown demonstrated how the QuartzBio® enterprise Biomarker Data Management (eBDM) 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.

The QuartzBio eBDM 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 QuartzBio 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, the QuartzBio eBDM 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 team can also further preprocess raw assay data directly and apply quality control metrics as well as normalization techniques. We can also extract relevant data and metadata from PDFs, such as omics reports and informed consent forms.

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 Data Management application 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.

ICF Codification QuartzBio
ICF Codification QuartzBio

September 21, 2022 — Biospecimens collected as part of biomarker-informed clinical programs are precious resources for precision medicine research and development (R&D). However, the complexity of tracking and linking informed consent data at the sample and derivative levels limits the use of these biospecimens.

Most informed consent data exists in uncodified informed consent forms (ICFs) and ends up in silos spread across multiple databases. It can be manual and time-consuming to compile information and surface insights.

In this post, we’ll explore how clinical teams can benefit from QuartzBio’s flexible approach to ICF codification to reduce complexity, gain more value from their stored samples, and help turn their biorepositories into drug development engines.

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.