News & Insights2021-02-08T17:22:09-05:00

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

Trends & Insights|

July 12, 2021 — 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.

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

Conferences & Events, Trends & Insights|

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

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A Technology-Driven Solution for Optimized Statistical Analysis of Clinical Trial Biomarker Data

Trends & Insights|

May 19, 2021 — Biomarker data generated to support clinical development has multiple roles:

  1. Inclusion in end-of-study regulatory submissions. As such, data must conform to FDA data exchange standards and need SDTM programming for analysis and submission.
  2. Supporting on-study decisions. Data must be stored in an accessible, flexibly structured format to adapt to on-study needs. These diverse needs include data visualization, mock TLFs, materials for investor meetings, posters, and reporting for safety review, data monitoring, and dosing decisions.
  3. Enable deep exploration to generate translational insights. Biomarker data generated during clinical trials presents opportunities for sponsors to further characterize mechanism of action and prioritize additional target pathways for their pipelines.

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New Asset for Precision Oncology: Source Biospecimens with Specific Mutations of Interest Using QuartzBio-Supported Repository

Trends & Insights|

May 18, 2021 — Identifying biospecimens with specific genetic alterations can be a significant challenge for research, particularly as teams target variants that occur at extremely low frequencies.

Now, translational researchers have a new resource for exploring the functional impact of genetic alterations. As recently announced, Precision for Medicine’s Biospecimens Solutions group has launched the Precision Oncology Sequencing Initiative (P.O.S.I.), supported by QuartzBio’s industry-leading biomarker data management and computational biology capabilities.

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

Trends & Insights|

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.

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