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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

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 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’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

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.

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.

Contact Us to Continue the Conversation

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.

Contact Us to Continue the Conversation

4 Strategic Imperatives Biomarker Operations image_2

Keeping track of clinical trial samples across multiple sites and vendors can be manual and tedious (recent post) — we have demonstrated how virtual Sample Inventory Management can streamline the day-to-day reporting of sample collections, shipments, and discrepancies (webinar series).

November 12, 2020 — In this article, QuartzBio Managing Director Scott Marshall discusses critical steps to integrating clinical, PK, and exploratory data on-study to advance operational and translational insights (without all the manual effort that has become all too common). With our experience working across dozens of clients and hundreds of studies, we’ve identified four key components necessary to efficiently centralize.