Health Decisions provides medical device developers with capabilities for streamlining clinical trials and reducing timelines and risk in a challenging area. The challenges of device development are substantial and growing. Uncertainty about the type of evidence required, perceived inconsistencies in regulatory review, increasing data requirements and long timelines are frustrating for device developers.1 Health Decisions offers the design and operational excellence and regulatory expertise required to overcome frustrations and accelerate development while also collecting high-quality data to eliminate the risk of delays in the 510(k) clearance or PMA review process. Our capabilities for conducting large subject-based IVD studies are the best in the industry.
Medical Device Development Services
- Protocol Development
- Project Management
- Site Feasibility and Selection
- Site Management
- Site Monitoring, including Risk-Based Monitoring
- Patient Recruitment and Retention
- Data Management
- Statistical Programming, Analysis and Reporting
- Interim Analyses
- DSMB Oversight and Coordination
- Regulatory Oversight and Compliance
- Supply Management
- Medical Writing
- Quality Assurance
- Safety Management
- Medical Monitoring
Medical Device Clinical Trials: Strengths in IVD Studies
Health Decisions has exceptional strength in large subject-based studies of IVDs. For example, Health Decisions established the gold standard for subject-based studies of HPV and other molecular diagnostics. Experience with such studies has made Health Decisions the CRO of choice when transitioning to FDA-required subject-based studies. Our gold standard best practices include:
We have expertise in sample handling and provide guidance to investigational sites on preparation, stability, shipment and other specific requirements for proper performance of each diagnostic under test.
Our LiveTrial CTMS has integrated capabilities for tracking samples from kit distribution to final storage, including tracking multiple samples and different types of samples for each subject.
Our clinical team has experience and expertise in technical monitoring of test laboratories from qualification and training through analytical and clinical validation.
Collecting and Monitoring Pathology Data
We have extensive experience collecting and monitoring clinical and surgical pathology data for consistency with inclusion/exclusion criteria and comparison with results from the test diagnostic.
We have capabilities for tracking enrollment in IVD studies by subtypes of results, enabling us to ensure enrollment of the required number of subjects for each category and stop enrollment upon reaching that number — a far more efficient approach than first enrolling a very large overall population and then identifying appropriate subjects. View the case study, “HPV Diagnostic Study Wins Race to Market by 2.5 Years, Saves $30M.”
Regulatory and Design.
With over 25 years’ experience designing studies and providing clinical and statistical data, Health Decisions has a proven track record of obtaining early regulatory agreement on control groups (concurrent or historical), objective endpoints (eliminating bias), quantitative cut points on positive and negative results, and handling of indeterminate results in the statistical analysis.
Agile Risk-Based Monitoring+
Health Decisions uses real-time data that enables remote, centralized monitoring while also ensuring higher data quality. With our Agile RBM+ approach, we have demonstrated the ability to simultaneously reduce SDV% and increase data quality. We work with sponsors to determine whether risk-based monitoring makes sense for each device study. We schedule monitoring visits dynamically based on conditions at each site, often reducing travel costs. View the white paper, From Here to Risk-Based Monitoring: A Framework and Checklists for a Successful Transition.
The LiveTrial Global CTMS
LiveTrial provides full visibility on each study and consistently delivers information appropriate to each role to all members of the study team, including both Health Decisions and sponsor staff. Learn more about LiveTrial.
1A Comprehensive Analysis of FDA 510(k) Process: Industry Practice and Implications for Reform. Institute for Health Technology Studies. May 24, 2011.