Health Decisions' Clinical Research Services
What is the benefit of finishing a clinical trial one month or even one year early?
Clinical research is plagued with inefficiencies. Traditional clinical research organizations (CROs) are entrenched in an outdated, inefficient model that wastes money, extends timelines, creates seemingly endless change orders, and delays market entry.
Unlike other CROs that profit from their own inefficiencies, Health Decisions acts as a strategic development partner, with proven processes that ensure the most effective pathway to market while cutting trial timelines and operational costs by 30% or more. For the past 20 years, Health Decisions has consistently delivered long-term value through our unique approach to research, Agile Clinical Development—a strategic three-pronged approach that combines adaptive design, adaptive operations and our proprietary technology.
With decades of experience conducting full-service Phase I – IV trials globally, Health Decisions sets itself apart from other CROs by our continued effort to shorten trial timelines and maximize efficiency through our approach to clinical research:
As a pioneer in adaptive design techniques and the first CRO to receive FDA approval for an adaptive study in oncology, our team works with sponsors to identify and implement FDA-approved techniques that allow for interim modifications based on data collected during the trial, for much greater efficiency.
Health Decisions’ proprietary HD360° Clinical Management System amplifies the capabilities of a study team by providing real-time study performance metrics necessary for making key decisions throughout the course of the trial. Advanced reporting, customized by role, gives all parties involved complete visibility into study progress and gives control back to the sponsor, enabling every member of a study team to work more efficiently while substantially reducing overall costs, timelines and risks.
Adaptive Enrollment - Through advanced reporting within HD360°, sponsors, sites and the team at Health Decisions receive real-time updates on how enrollment is tracking toward goals. At the first sign of poor performance, our team works with sites to eliminate delays and future repeat errors. Real-time access to site performance metrics combined with our experienced team of CRAs enables Health Decisions to enroll 85% of studies on time and 65% early, compared with the industry average of 10 percent.
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 with a data-driven, needs-based approach to site visits.
Regardless of therapeutic area, the combination of decades of experience with adaptive design and our cutting-edge adaptive operations techniques allow Health Decisions to drastically reduce trial timelines and eliminate budget-draining inefficiencies.
Health Decisions offers a full range of clinical research services to biotech, pharmaceutical and device companies, including:
- Study Development
- Site Selection
- Patient Recruitment
- Project Management
- Site Management
- Data Management
- Data Validation and Verification
- Statistical Programming, Analysis and Reporting
- Regulatory Oversight and Compliance