Combining eCOA and Ground-Breaking Movement Disorders Digital Biomarker Platform to Evaluate and Predict PD Severity.
Horsham, Pennsylvania; December 14, 2022 — Clinical ink, a global life science technology company, has partnered with a leading biopharmaceutical organization focused on Parkinson’s Disease research to deploy remote technology that captures study participants’ symptoms at home and clinical sites in the United States and Europe.
This late-phase clinical development program follows patients over the course of eighteen months and aims to identify measures that can detect Parkinson’s disease progression before the onset of significant symptoms. By adopting Clinical ink’s BrainBaseline platform, researchers are now able to access essential insights into Parkinson’s disease progression via remotely monitored sensor biometrics and wearable data collected passively and during fit-for-purpose active tasks.
The BrainBaseline™ Movement Disorders Platform has been enhanced by over 10 years of high-dimensional data collection and research, becoming the premier digital biomarker platform in the field. Through advanced data analytics, Clinical ink has derived over 3,000 data features from voice, movement, cognitive, and behavioral tasks.
By incorporating these clinically and behaviorally selective features into our models, Clinical ink data scientists can accurately distinguish healthy volunteers from patients with early-stage Parkinson’s disease 92% of the time, with 90% sensitivity and 100% specificity. In combination with Clinical Ink’s advanced eCOA capabilities, this project will generate additional clinical data to correlate traditional outcomes assessments like the MDS-UPDRS, MoCA, CGI, PGI, and PDQ-39 with the advanced sensor-driven biomarkers of Parkinsonian symptoms. “The team is now able to gather richer, more nuanced, and accurate data to enhance and support our models and advancement of digital biomarkers for clinical use,” says Joan Severson, Chief Innovation Officer at Clinical ink. “The outcomes of this project will improve diagnosis, tracking and treatment of Parkinson’s while making clinical trials more efficient, leading to faster drug discovery not only for Parkinson’s, but potentially for a range of neurological conditions.”
Ed Seguine, Chief Executive Officer at Clinical ink, said: “As the leaders in amassing Parkinson’s patient data (passive and active), we will be able to predict disease severity, progression, and therapeutic responsiveness. We are honored that our mobile and wearable technology plays an integral role in this study of Parkinson’s disease and to advance our development of digital phenotypes and biomarkers.”
This work follows Clinical ink’s groundbreaking initial findings in the WATCH-PD study, part of the Critical Path Institute’s 3DT and Parkinson’s initiatives, which provides preliminary support for the generation of digital biomarkers associated with Parkinson’s status.
More information about the passive and active assessment foundational in the BrainBaseline Digital Biomarker platform can be found here.
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About Clinical ink
Clinical ink is the global life science company that brings data, technology, and patient science together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience.