Our client needed a platform to process and store clinical trial data captured from many sources including heart rate (ECG), electroencephalogram (EEG), gaze tracking, facial actions, and clinical measures. The platform needed to support future trials across many trial sites. Quality assurance of data was a particular concern. Version tracking and compliant logging of the data was needed. The data needed to be structured for data science analyses to support optimized clinical trial outcomes.

We designed and implemented a platform to import, process and store clinical trial data. The platform supports data from all relevant sources (biosensors, metadata, etc.). The system includes data lineage and logging and is compliant with regulatory standards. All imported data is processed through quality assurance pipelines to clean and normalize. Graphical interfaces were built to support manual data review. The system enables visualization of clinical trial data sets and alerts scientists to data concerns. The platform provides data that is optimized for data science and biostatistical analyses, and is the foundational component for future planned clinical trials.

This case study references work that was co-published with Janssen in the 2022 ANCP poster abstracts "P395. Replication of the N170 Response to Faces for Use as a Potential Stratification Biomarker in Clinical Trials for Autism Spectrum Disorder" & "P396. Identification of Stable Clinical Subtypes in Autism Spectrum Disorder Using the Autism Behavior Inventory"