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. These diverse needs include data visualization, mock TLFs, materials for investor meetings, posters, and reporting for safety review, data monitoring, and dosing decisions.
- Enable deep exploration to generate translational insights. Biomarker data generated during clinical trials presents opportunities for sponsors to further characterize mechanism Read More →
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.Read More →
Webinar On Demand: Exploring IO Signatures in Clinical Trial Genomic Data
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 relate clinical response data and gene expression data to regions of genomic alteration.
- Correlate genomic data with known signatures of immuno-oncology (IO) response through integrations with public data, knowledgebases and sponsor data.
- Define patient subgroups to generate deeper Read More →
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.Read More →