Health Decisions

Medical Device Research Services

The fact is, regulations are tightening on new medical devices entering the market. For device manufacturers, this could mean longer studies, more patients, increased costs, and longer time to market and revenue.

Due to these changes, it is becoming increasingly important for medical device companies to partner with a CRO that understands the device industry and has extensive medical device expertise. Health Decisions embraces the efficiencies needed for successful medical device development.

With more than 20 years of experience, our goal is to help sponsors create an efficient development program and conduct adaptive studies for Class II and Class III diagnostic, therapeutic and surgical devices, including studies to support  Premarket Approval (PMA) applications and 510(k) Premarket Notifications.  

Health Decisions’ Agile Clinical Development Methodology - a strategic three-pronged approach that combines adaptive design, adaptive operations and proprietary technology - shortens trial timelines and reduces risk in device studies.

Health Decisions’ Benefits

Adaptive Design - Through Health Decisions’ protocol consulting services, our team will identify and design a protocol that incorporates the appropriate Adaptive Design techniques that will drastically reduce trial timelines, and reduce operational costs of the study.

HD360° Clinical Management System, Advanced Electronic Data Capture (EDC) and Adaptive Operational processes provide instant access to data to improve study performance:

• High Enrollment Success - Health Decisions enrolls 85% of studies on time, compared to the industry average of 10 percent.
• Low Waste and Rework - Our query rates are 0.5-2/100 fields vs. industry averages of 5-7 for most webEDC systems and 15+ for paper.
• EDC – Advanced EDC technologies, such as the SmartPen, provide instant access to CRF data and eliminate source data verification, freeing up monitors to focus on site management.
• Fast Database Lock – Health Decisions averages two weeks, compared to the industry average of ~10 weeks, but our team can lock the database within days of Last Patient Last Visit (LPLV).

Adaptive Monitoring - Performance metrics within HD360° maximize the efficiency of day-to-day monitoring functions such as query management. Through real-time patient data and site performance metrics, Adaptive Monitoring replaces the fixed schedules and rigid adherence to pre-ordained plans used in traditional studies. This enables monitors to focus on building relationships with investigators focused on device functionality and performance.

Medical Device Services