Biomarker Operations Archives - Page 3 of 4

Join QuartzBio at the SCOPE 2022 Summit for the “Clinical Biomarkers Operations and Innovation” track on February 8-9.

PRESENTATION: “30 Days to an Annotated Virtual Repository — Without Changing DTAs”

Clinical and biomarker operations teams can create ongoing visibility into sample collection, processing and testing by linking biospecimen metadata, informed consent, and biomarker data across multiple LIMS and inventories.
Mike Waters will share how teams are using technology to access a single source of truth for sample inventory management.

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 arti c les, 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.

Join QuartzBio at the SCOPE 2021 virtual conference for the “Clinical Biomarkers Operations and Innovation” track on March 2.

PRESENTATION: “Centralizing PK, Clinical, and Exploratory Biospecimen Data to Streamline Trial Operations & Intelligence”

Clinical samples are frequently a logistical headache – managed too often in Excel files that are time-consuming to update, and quickly fall out of date. Modern biomarker-centric programs demand a focused strategy to provide timely visibility into sample availability and quality.

Dr. Tobi Guennel will share how clinical teams are leveraging technology to quickly and efficiently gain visibility into their clinical samples across sites, labs, and storage facilities.

May 14, 2020 — Modern clinical trials distribute samples to an expanding range of screening labs, specialty labs, and bio-banking facilities. Maintaining visibility into sample collection and data processing too often requires manually comparing inventories from each lab’s LIMS, and then checking against what is expected according to the protocol.

April 1, 2020 — The global pandemic caused by COVID-19 is presenting a public health crisis, and unprecedented challenges in the conduct of clinical trials. The quickly realized disruption has motivated FDA and EMA to issue guidance in direct response. As we continue to adapt to the new reality, we are seeing proactive monitoring of strained health care systems and potential for shipping disruptions as top of mind issues for Sponsors operating ongoing trials. This is especially true as Sponsors work to maintain R&D momentum and continue to serve patients – while adapting to an increasingly remote workforce requiring virtual collaboration.