High-Throughput Data Pipelines for Clinical Research

Digital health technologies integrated into the clinical trial workflow

Digital biomarkers that predicted specific symptom profiles within a neurological disease
The challenge

A biopharma sponsor was running a series of phase 1 and 2 clinical trials targeting a neurological disease. Their protocol involved gathering a large battery of biosensor data from ECG, EEG, and eye trackers in response to social tasks.

Their goal was to identify measures that distinguish case from control groups and further stratify the case group into smaller, clinically-meaningful subgroups in a reproducible way across studies.

These analyses required handling and quality assuring complex data from the biosensors before the sponsor’s biostatistics team could perform the analyses in the statistical analysis plan (SAP).

Our Solution

Our library of high-throughput data processing and quality assurance workflows enabled the sponsor to complete all trial data analysis in a matter of days including all manual review steps. The resulting clean data was readily used by the biostatistics team to perform all analyses outlined in the SAP.

Our solution also provided the sponsor with a dashboard showing the results of a collection of automated statistical calculations, enabling them to monitor their study populations as data arrived.

Beyond the SAP, our team also identified biomarkers that predicted specific symptom profiles within the neurological disease. These were found to exhibit different behaviors between treatment and placebo populations.

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