We are a multidisciplinary team of clinicians, research scientists, and biomedical engineers focused on the clinical development and process automation of evidence-based, person-centered medical technology innovation, such as: non-invasive digital devices for vital sign monitoring, digital therapeutics, medical decision-support systems or patient health gamification (AI, SaaS, or IoT), and other virtual care assistive technologies that benefit vulnerable patient groups. Our team’s expertise aligns well with medical history taking and monitoring that informs the decisions and actions of care providers. Examples include vital signs (such as heart rate and blood pressure) that can be monitored by a patient or with the support of an informal care provider from their home to facilitate preventative medicine, lifestyle modifications, medication titration and adherence as well as for early detection or worsening of a disease. Advances in healthcare technology are changing the standard of care to reduce healthcare costs and to be more convenient for physicians and patients to effectively improve health outcomes.
If you are interested in learning more about our work to clinically calibrate, validate, and assimilate health care technology innovations into a real-world setting, please contact us: firstname.lastname@example.org.
What Do We Offer?
The Good Clinical Practice (GCP) clinical research services that we provide include:
- Literature reviews
- Clinical trial design and implementation
- Guidance with federal regulatory filing and compliance
- Research Ethics Board (REB) submissions
- Study participant recruitment
- Research data management & Statistical analysis
- Grant writing support
- Knowledge Translation (KT)
- Peer-reviewed publications
- Intellectual property (IP) diversification
- Translational medicine market review
Meet Some of Our Collaborative Industry Partners:
A national, multicentre study to calibrate and validate a non-invasive device for the early detection of coronary artery disease. The CAD-det device records the blood flow sounds of turbulent flow in blocked or partially blocked arteries of the heart.
Current Clinical Trial:
- Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease (The CADdet Study) https://clinicaltrials.gov/ct2/show/NCT03914079
We are conducting clinical studies to calibrate and validate the breathing rate and blood pressure measurements of the Pulsewave Health Monitor PAD-2A wrist cuff blood pressure device. The non-invasive, automatic device estimates the vital sign measurements via the pulse pressure of the radial artery.
Current Clinical Trials:
- Calibration & Validation of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device
- Calibration & Validation of the Cloud DX Pulsewave Health Monitor (PAD-2A) Oscillometric Wrist Cuff Home Blood Pressure Monitor, According to the Association for the Advancement of Medical Instrumentation/ European Society of Hypertension/ International Organization for Standardization Universal Standard
- Melville S, Teskey R, Philip S, Simpson JA, Lutchmedial S, Brunt KR. A Comparison and Calibration of a Wrist-Worn Blood Pressure Monitor for Patient Management: Assessing the Reliability of Innovative Blood Pressure Devices. J Med Internet Res. 2018 Apr 25;20(4):e111. doi: 10.2196/jmir.8009.
Routinify is developing a remote care management telecare platform, WellAssistTM for scheduling daily routines and vital sign monitoring via validated devices that includes access to electronic health records and regular communication with health care teams.