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 Mike Waters, QuartzBio Vice President of Sales. After learning about Mike here, please feel free to connect with him on LinkedIn.

In your own words, what do you do?
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.
What is your fondest memory of working at QuartzBio?
It is not a single memory, but rather the culture of the organization that inspires me to do the best work I possibly can for our customers, my colleagues, and the patients that we serve. We do our best work as a team. There is mutual respect for all who contribute whatever it takes to deliver a world class customer experience.
Complete this sentence: QuartzBio is _________ because _________.
QuartzBio is best solution in the market because we say what we are going to do and then we do it. You can count on us.
Complete this sentence: QuartzBio customers are _________ because _________.
QuartzBio customers are innovators because they seek new solutions to address existing challenges.
What piece of art – book, movie, music, artwork, etc. – inspired you the most and why?
I get great pleasure from all forms of art, especially music. The Beatles are my favorite band. Not only because they composed some of the greatest pieces of pop music of the late 20th century but because their music and perspectives evolved and matured over their amazing 10-year career. Curiosity and growth inspire me in all endeavors.
What’s the best piece of advice you have ever been given?
You can’t make more time. It is the most precious resource we have. Use it wisely.

Connect with Mike Waters on LinkedIn

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.

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 for Clinical & Biomarker Operations - QuartzBio

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).

Duration: 30 minutes

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

Register for the webinar here

Title: Critical Biomarker Operations KPIs Across Clinical Portfolios

Duration: 30 minutes

Clinical and biomarker operations teams face challenges with global site footprints, complex sample lifecycles, and inconsistent naming across sites and vendors.

Watch our webinar to learn how teams are monitoring key performance indicators (KPIs) for clinical sample status, quality, and data availability – on-study and across clinical portfolios.

Adam S. Brown, PhD of QuartzBio will share how teams are assessing key deliverables:

Site performance including collection rates, collection quality metrics, and automated reporting for consent and protocol violations.
Vendor operational performance such as adherence to contracted turnaround windows and time to analysis.
Results data availability across assay modalities at study, cohort, patient, and sample levels – with comparisons of actual vs expected events, and forward-looking projections.
Sample and derivative availability across active and completed studies, including in-depth profiling of viability and volume, consent status, and expiration dates.

Watch the Webinar

February 18, 2022 — At our first in-person conference in over a year, the QuartzBio team had a chance to connect with biomarker operations and clinical operations teams in Orlando, Florida, earlier this month.

In the “Clinical Biomarkers Operations and Innovation” track, we joined discussions on the latest approaches to structuring clinical sample management to best support complex biomarker-informed clinical trials.

Here are three recurring challenges we heard about at SCOPE this year:

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.

Register for the webinar here

Title: Keeping Track of Clinical Samples in Biomarker-Rich Clinical Trials

Duration: 30 minutes

Learn how clinical operations and translational teams are creating “sponsor-centric” visibility to reconcile sample status and location on-study.