Proactive management rapidly turns decisions into actions that reduce timelines and risk and increase efficiency. Only a proactive approach can ensure that each study meets goals for data quality and patient safety as well as optimizing use of sponsor resources. Retrospective activities remain important in trial management – error detection and correction are essential safeguards. However, a current understanding of study status at all sites regardless of location is far more important. Predictive modeling is another vital tool in the proactive PM’s toolbox, allowing anticipatory intervention to head off problems while they remain mere threats. Our study teams do not wait for periodic reports to find out what is happening in your study. Instead, our PMs and CRAs continuously track performance based on streaming LiveData and intervene to correct emerging problems.
The combination of LiveData, predictive analytics and comprehensive training in a proactive approach to trial management enables Health Decisions’ study teams to meet and exceed the goals of biopharma and device sponsors worldwide. Rapid and effective problem identification, problem solving, and problem escalation in accordance with a sponsor-approved communication plan are hallmarks of the Health Decisions approach to managing clinical studies.
The Health Decisions proactive management approach extends to all aspects of study execution, including enrollment, monitoring and site management. Proactive management of enrollment includes continuous assessment of enrollment strategies, messaging and media, referral sources and reasons for screen failures. Proactive management of monitoring includes data-driven scheduling of site visits and utilization of risk-based techniques to focus attention on data and procedures that matter most to the success of each study. Proactive management of site compliance includes close tracking of query incidence and resolution, protocol violations and variability in results of study procedures.
Sponsors often praise the proactive mentality, responsiveness and communications skills of Health Decisions’ clinical staff and their ability to integrate with sponsor staff in effective virtual teams. View sponsor testimonials about Health Decisions.