Biomarker Operations Archives - Page 3 of 4

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.

November 19, 2021 — As we discussed in our recent webinar, QuartzBio’s virtual Sample Inventory Management (vSIM) solution empowers clinical operations and translational research teams by integrating multiple sources of sample information, both within and across studies.

The platform enables users to interact with harmonized data from multiple sources, gain critical insights via KPI and data issue reporting, and manage queries resulting from those data inconsistencies.

Register for the webinar here

Title: Advancing Clinical Sample Management with a Virtual Sample Repository

Duration: 30 minutes

You’ll see how a virtual repository delivered via QuartzBio’s translational hub provides visibility into clinical sample status:

Sample visibility across studies, central labs, third party vendors, biorepositories, and disparate source systems
KPI dashboards that report sample status including collection, processing, testing, consent, expiration – while highlighting collection gaps and discrepancies.
Dynamic visualizations to quickly review expected vs actual sample status by patient, time point, and assay type

October 8, 2021 — Sponsors are challenged to keep track of complex sample inventories, both on study and for samples collected as part of completed studies that might be later mined for translational research needs. We frequently hear that teams spend significant time manually cross-referencing spreadsheets of inventory data, to answer questions such as:

“How many whole blood samples with a particular mutation do we have across all phase I studies?”
“Can we report sample expiration status across all of our contracted biorepositories?”
“When we identify a sample of interest, how can we confirm consent status?”

Register for the webinar:

Title: Overcoming Clinical Sample Chaos: A Critical Step in Biomarker-Rich Trials

Duration: 45 minutes

You’ll see how a technology-enabled approach to clinical sample inventory management delivers:

Sample KPI dashboards for clinical, translational, & data management teams
Visibility into sample collection, processing, and consent status
Dynamic visualizations to quickly review expected vs actual sample status by patient, time point, and assay type

Complex biospecimen operations are inherent in modern clinical trials. For recent protocols, biospecimen collections are designed to be broad and to enable flexible selection from the variety of biomarker assay technologies that are available. Biomarker clinical operations are critical to realizing the potential of biomarker data generation plans.

Multiple Labs, Multiple LIMS; Lack of Sponsor-Centric Visibility

In previous webinars and articles, we have analyzed key challenges facing biomarker operations. Given the expanding footprint of sites, labs, and biorepositories, there is no sole source where sponsors can find information on biospecimens and get insights into the whereabouts of a given specimen within its complex journey across sites, labs, and biorepositories.

In this post, we explore the relationship between “lab-centric” and “sponsor-centric” sample inventory reporting, and how connecting these inventories can keep data generation on track.

March 8, 2021 — At last week’s SCOPE 2021 virtual summit for clinical operations executives and their partners, an overarching theme was the increased speed of clinical operations in response to the COVID-19 pandemic.

“Speed — is this the new normal? Can we as organizations support that ramped-up speed … with the resources that we all have?” asked moderator Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck & Co., at Tuesday’s panel discussion in the Clinical Biomarkers Operations & Innovations track.

QuartzBio’s SVP of Data Management and Systems Integration, Tobi Guennel, joined leaders from Bristol-Myers Squibb, Eli Lilly, AbbVie, and Covance for this live panel.