Incorporating New Data Streams While Reducing Costs
Integrating digital biometrics from wearables and remote devices into clinical study data delivers a number of advantages to patients, sites, and sponsors of medical therapeutics. The continuous collection of biosensor data can support digital endpoints and a more compelling regulatory case. During the COVID-19 pandemic, the regulatory authorities have recommended contactless continuous remote monitoring using approved devices out of an abundance of safety. This approach is also supported by the professional rhythm organizations such as the Heart Rhythm Society and European Heart Rhythm Association, with continuous remote rhythm monitoring for cardiac safety.
From the viewpoint of drug development, the comprehensive data streams produced by digital biosensors impact study design, patient selection, and go/no-go decisions. Concurrently, patient recruitment and compliance improves, as patients welcome fewer office visits and adhere more closely to the trial protocol requirements, which reduces protocol deviations. Decreasing site visits by remote sensing devices also reduces site and resource burden which impact cost savings tremendously. Site coordinators and investigators now have deeper and more efficient insights into the patients’ overall health, compared with traditional data-limited approaches, and accurately track compliance for early re-engagement with those at risk of drop-out. The specific devices used are selected and vetted by Medpace’s therapeutically-aligned teams to meet tailored study design requirements, streamline vendor management, and accelerate study start-up.
The Medpace Advantage to Connected Devices
- Selection of trial-specific validated sensors
- Ensuring device logistics and availability to sites
- Secure data capture and storage
- Integration into clinical study records
- Review, analysis, harmonization, and visualization of trial data
- Transforming data to support regulatory review
Core Lab Integration
Medpace Core Labs provide another level of oversight and analysis for essential biometric data, such as ECGs , blood glucose, cardiac output, actigraphy, volume status, and vital signs. Our integrated core labs provide an end-to-end suite of global imaging and cardiac safety services to enhance and expedite biopharmaceutical and medical device development. Biosensors produce prodigious amounts of previously untapped health data for clinical studies, and Medpace is able to integrate these data into the overall study and harmonizes it to present strong regulatory cases. The diagram below illustrates the connection between sensor data and integration into the study.
The enormous amount of data from patient biosensors requires up-to-date security infrastructure and controls, data transfer protection, cybersecurity software, firewalls, and data breach and attack simulations (BAS), along with the expertise to review and analyze these digital biomarkers and report and visualize the results in a format that expedites regulatory review. Cyber contingency plans for data breaches must be detected immediately and corrected swiftly with mitigations to protect accurate data entry and collection, especially to achieve regulatory requirements for pharmacovigilance. BAS serve to test the security controls of the Medpace environment to guard against the latest threats to cyber and data security.
A Full-Service CRO that Provides Full-Service Remote Patient Sensing
Medpace seamlessly integrates the centralized collection and harmonization of data from wearables and remote devices into your clinical studies as part of our full service offering. The ability to coordinate all services under one roof provides an accountable and efficient platform – while reducing your need for duplicate management oversight. Benefits include:
- Streamlining vendor selection and management – one-stop shopping
- Faster and efficient execution by leveraging our existing relationships and experience with device manufacturers
- Early consideration during study design – devices selected and vetted to address specific endpoints
- Technology and expertise to support integration into overall study data and management
- Tailored & weighted algorithm to vet and select biosensor vendor with resultant customized device “catalogue” to be shared with sponsor
- Facilitated integration of sponsor-selected devices using our “Vendor-neutral Platform” to bridge the communication from device to database
- Medpace Core Lab expertise to monitor and analyze essential biomarkers