QuartzBio Team, Author at QuartzBio

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Entries by QuartzBio Team

4 Strategic Imperatives for Clinical and Biomarker Operations

Keeping track of clinical trial samples across multiple sites and vendors can be manual and tedious — we have demonstrated how Sample Intelligence can streamline the day-to-day reporting of sample collections, shipments, and discrepancies.

Webinar: Monitoring Site and Vendor Performance Metrics Across Studies

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 […]

Streamlining vendor oversight: Monitoring site-level and laboratory performance across multiple oncology trials

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 […]

6 Critical Discrepancy Reports for Effective Clinical Operations

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, […]

From IHC to Immune Profiling: Managing Data Breadth and Depth to Inform Clinical Programs

With immuno-oncology assets progressing in the clinic, a growing biotechnology company we work with faces an increasingly common challenge: Their trials are generating large datasets across a wide range of assay modalities (Figure 1), but the data remains siloed. In addition to clinical data coming from the clinical research organization (CRO), the velocity of data […]

Monitoring Consent Status With a Novel Virtual Repository

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 […]

From Translational Teams to Biomarker Operations: The Cross-Functional Impact of a Fragmented Clinical Trial Data Ecosystem

Clinical samples are moving across an increasing number of physical/virtual locations and data is delivered in an expanding array of file formats as clinical trials become increasingly more complex and data-rich (report). Biospecimens are analyzed using a variety of assay technologies, each generating its own set of reportables, quality control metrics and data/file formats. Data […]

Connecting LIMS to a Master Sample Inventory to Provide Sponsor-Centric Visibility for Biomarker and Clinical Operations

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 […]

Translational Intelligence: Exploring Immunotherapy Response Signatures with Clinical Trial Genomics Data

May 5, 2021 — As the data generated during a modern clinical trial has dramatically expanded, sponsors must continuously evaluate novel approaches to help bridge the gap between millions of data points and breakthrough scientific insights (a goal we describe as delivering Translational Intelligence). One such example is assessing signatures of “hot” and “cold” tumors.

Translational Intelligence: Synthesis and Integration of Genomics Data in Clinical Trials

April 21, 2021 — A modern clinical trial, with well-characterized subjects studied over periods of time, presents unmissable opportunities for sponsors to characterize mechanism of action, prioritize target pathways for their pipelines, and generate as much data as possible to support regulatory filings.