Together, CDS and SAT are leveraging the latest mobile and wearable technologies to achieve remote, longitudinal tracking of biomarkers in clinical trials
Crucial Data Solutions, Inc. (CDS), a provider of software to advance clinical research, and SISCAPA Assay Technologies, Inc. (SAT), a biotechnology company focused on understanding longitudinal changes in health and disease, announced today they have formed a strategic partnership to increase the quality and quantity of data gathered in clinical trials. Infrequent data collection is a common problem that is solved by uniting CDS’ technology with SAT’s expertise to facilitate optimal and continuous remote patient monitoring.
SAT has implemented CDS’ TrialKit™ data collection and study management platform to collect, store, and analyze multiple streams of data. Because testing occurs infrequently, many health events go undetected during a trial. SAT’s LongitudeDX™ (LDX) directly addresses this challenge via high-frequency sampling, high-content biomarkers, high-precision measurements and high-resolution personalized models. LDX participants conduct their own at-home, daily blood collection, requiring just one to two minutes per day. The monthly 32-sample collection kit, SampleDiary™, enables routine, remote collection of high-quality blood samples. The blood sample data are then integrated with data from a variety of other digital sources, allowing researchers to arrive at more accurate conclusions, driving better outcomes.
“LongitudeDX relies on TrialKit to document the collection of dried blood samples and upload data from users’ mobile devices to secure storage in the cloud,“ said Leigh Anderson, CEO of SISCAPA Assay Technologies. “Collaborating with the experienced TrialKit team has been a very cost-effective method to rapidly design and test a capable and polished product. We look forward to adding additional mobile health data streams as we expand our partnership.”
Additionally, patients’ data are collected via Apple Watch® enabling SAT to integrate data into TrialKit. This ensures continuous data collection of a variety of health metrics, including heart rate variability, resting heart rate, sleep patterns, ECG, daily activity rings, and blood oxygen (SpO2) levels. TrialKit’s downloadable mobile app has allowed SAT to achieve 100 percent remote, real-time patient monitoring for LDX in a regulated environment.
“CDS is proud to collaborate with SAT to push the envelope and advance the pace of innovation and real-world, continuous patient data collection in clinical research,” said Jeff Rogers, President of Crucial Data Solutions. “Once considered unattainable, SAT has proven that TrialKit’s mobile app and out-of-the-box integration with wearables is a legitimate option for organizations considering the adoption of continuous, remote patient monitoring techniques to support their research.”
To date, over 4,000 blood samples have been gathered in the LongitudeDX project. CDS and SAT are now adding additional remote data sources by integrating with devices such as continuous glucose monitors, CPAP machines and blood pressure monitors that further expand access to patient data.
About Crucial Data Solutions
Founded in 2010, Crucial Data Solutions (CDS) provides data collection and clinical trial management technology on the market today. TrialKit, our cloud-based platform available via a web interface and downloadable native mobile app, enables end-to-end clinical trial management for pharmaceutical, biotechnology, and medical device companies of all sizes. https://www.crucialdatasolutions.com/
About SISCAPA Assay Technologies
SISCAPA Assay Technologies, Inc. (SAT) provides products and services for precise quantitation of protein biomarkers, drugs and drug targets using immuno-affinity mass spectrometry (https://www.siscapa.com). SISCAPA assays are used in clinical diagnostics and pharma R&D for particularly demanding applications, and in biomarker panels to characterize changes in health, disease and treatment in longitudinal user-collected dried blood microsamples. (https://www.longitudedx.com)
