From Translational Teams to Biomarker Operations: The Cross-Functional Impact of a Fragmented Clinical Trial Data Ecosystem
August 31, 2021 — Clinical samples are moving across an increasing number of physical/virtual locations and data is delivered in an expanding array of file formats as clinical trials become increasingly more complex and data rich (report).
Biospecimens are analyzed using a variety of assay technologies, each generating its own set of reportables, quality control metrics and data/file formats. Data is delivered through multiple, disconnected pipelines (Figure 1).
This complexity creates obstacles for many functional groups within sponsor organizations:
Read More →
Webinar On Demand: Transcending Biomarker Data Chaos
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 IDs, time points, response status, and treatment groups
- Access data rapidly – point and click navigation to underlying data files to interrogate the raw data behind the summary values
- Interrogate cross assay – map to a common data Read More →
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 selecting patients, predicting therapeutic response, and informing key development decisions.
Read More →
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 →
