Register for the webinar here Title: Transcending Biomarker Data Chaos: How Integrating Disparate PK, Clinical & Exploratory Data Enables Deep Translational Insights Duration: 30 minutes You will see how teams unlock translational intelligence: Navigate vast exploratory data – identify trends and data points of interest Surface insights – analyze biomarker trends in collaborative dashboards across subject […]
July 29, 2021 — Translational research teams producing large datasets from biomarker-rich trials quickly face the next challenge: generating actionable insights from their data. As we described in a previous case study, we have been working with many teams to enable deep mechanistic insight generation from their biomarker data to aid in signature development for […]
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 […]
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 […]
May 19, 2021 — Biomarker data generated to support clinical development has multiple roles: 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. Supporting on-study decisions. Data must be stored in an accessible, flexibly structured format to adapt to on-study needs. […]
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.
Watch the webinar on demand: Title: Translational Intelligence: Exploring IO Signatures in Clinical Trial Genomic Data Duration: 30 minutes You will learn how to: Visualize gene alterations and tumor mutational burden (TMB) using heatmaps and tables, with subject and time point granularity. Identify genes of interest and candidate signatures using visualization and statistical methods to […]
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.
April 9, 2021 — With the rise of biomarkers used in clinical trials (e.g., prognostic, predictive, pharmacodynamic) and biomarker assay modalities (e.g. flow cytometry, multiplex protein detection, gene expression profiling), biomarker and specialty lab data are increasingly incorporated into FDA submissions. This data provides insights into key clinical objectives, including pharmacological effects, and drug safety […]
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 […]
Precision for Medicine is the first biomarker-driven clinical development organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments. Precision for Medicine is part of Precision Medicine Group, with 3,000 employees in 40 locations.
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