February 2021 - QuartzBio

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frequently a logistical headache – managed too often in Excel files that are time-consuming to update, and quickly fall out of date.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.

February 12, 2021 — Integrating clinical and biomarker data enables both operational insights as well as scientific insights that can help teams make clinical trial decisions on-study.

Our last article defined the synthesis of these insights as translational intelligence, with the potential to illuminate key insights in drug development just as business intelligence is used to optimize business performance. We showed that, for example, having all the biomarker and clinical data linked together enables sponsors to quickly explore the relationship between drug response status and specific biomarkers of interest.

In this post, we further illustrate how translational intelligence works in practice with example applications. Translational intelligence not only illuminates key trends that may be missed through manual data review, but it also facilitates the seamless exploration of interlinked clinical, PK, and exploratory biomarker data assets.

Sign up to watch the webinar on demand:

You will learn how to:

Expand your use of exploratory biomarker data in combination with clinical metadata for on-study analytics
Centralize integrated biomarker and clinical data as a single source of truth to expedite drug development decisions and enable translational exploration
Leverage dashboards to support collaboration and quickly surface actionable insights

Abstract of the Webinar

Today’s clinical trials have global footprints to reach targeted patient populations and rely on specialty labs running complex assays to assess safety, characterize patient response, and provide insight into efficacy.

These biomarker-centric programs demand a focused strategy to provide timely visibility into sample availability and quality, data availability and quality, and critical on-study measurements.

Much of the information necessary to deliver biomarker intelligence exists today – though it is dispersed across workstreams (e.g. sample, assay, clinical, consent) and stakeholders (e.g. CROs, sites, labs, sponsors) and systems (e.g. EDC, CTMS, LIMS).

Just as EDC adoption accelerated the centralization of clinical data, our team will highlight the opportunity to integrate and centralize biomarker data, the unique challenges that have historically faced the industry, and how overcoming these challenges can unlock transformative insights.

In this on-demand webinar, “Critical On-Study Biomarker KPIs for Modern Trials: Integrating Data Silos to Unlock Scientific Insights and Empower Translational Teams,” we will discuss the opportunity to expand the use of exploratory data for on-study insights. Topics to be covered include:

Centralizing integrated biomarker and clinical data as a single source of truth to enable insights into PK/PD effects as well as translational exploration
Leveraging dashboards to support collaboration and quickly surface actionable insights

Throughout the discussions, our team will highlight how smart technology, consisting of sophisticated connectors and scalable data workflows, enables the rapid assimilation and synthesis of historically disparate data. This use of technology enables insights today – rather than as the product of years long enterprise investments – and reduces the burden, frustrations, and delays associated with manual data reconciliation and a patchwork of homegrown solutions.

Watch the Webinar

February 3, 2021 — In this brief, we explore Translational Intelligence – that is, navigating the vast biomarker data ecosystem to quickly uncover insights that would be missed by visual inspection alone, and which enable translational teams to focus on the right pathways, biological mechanisms, and / or patient populations.