Entries by raincastle

Webinar On Demand: Transcending Biomarker Data Chaos

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 […]

How to Use Technology to Contextualize Biomarker Data Within Decades of Experimental Results for Intuitive Biological Insight Generation

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 […]

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

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 […]

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

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 […]

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

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. […]

Webinar On Demand: Exploring IO Signatures in Clinical Trial Genomic Data

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 […]

Delivering CDISC-Compliant Submissions of Biomarker and Specialty Lab Data

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 […]

Folate pathway gene expression in metastatic colorectal cancer patients treated with arfolitixorin/5-FU-based chemotherapy

April 2, 2021 — Gene expression biomarkers can help predict clinical outcomes in response to treatment with pathway-targeting therapeutics, thereby helping to identify patient subgroups likely to respond. In a collaboration with investigators at Isofol Medical AB, the QuartzBio team analyzed the correlation between expression of folate pathway genes and clinical outcomes in response to […]