On-Time Trials’ CEO Trevor Coughlan recently attended the WCG MAGI conference in Philadelphia in May 2023. One of the recurring themes was Staffing and Retention and the burnout experienced by Clinical Research Associates. On-Time Trials has a solution rooted in Lean operations that features a “Just-In-time” algorithm that accurately predicts future workloads that helps workload and improves morale.
Managing Staffing Difficulties in Clinical Trials
Addressing turnover in clinical research is crucial as trial backlogs increase and studies become more complex and diverse. In this regard, OTT (On-Time Trials) offers effective solutions to right-size the capacity of Clinical Research Associates (CRAs) and ensure comprehensive site support, while our Just-in-Time (JIT) algorithm helps balance workloads to reduce burnout and turnover.
How OTT Modules Optimize Capacity and Support for your team & while preventing burnout.
OTT utilizes headcount planning algorithms that consider various factors, such as protocol design, failure rates, timelines, schedule of events, CRF design, risk-based monitoring plans, and the expertise of CRAs in specific therapeutic areas and operational aspects. Additionally, OTT takes into account the regulatory complexities of each trial, enabling CRAs to confidently interact with sites, whether in person or remotely, and efficiently complete their tasks while leaving the site in good standing. This module allows for the appropriate sizing of monitoring capacity at the beginning of the trial.
OTT also incorporates information on the zip codes of sites and CRAs, enabling travel time calculations to optimize support. By providing comprehensive support, CRAs can enhance their ability to understand eligibility requirements and study conduct, thereby improving the site’s chances of success, patient safety, and data quality.
Currently, a significant amount of capacity in trials goes to waste due to delays. CRAs may spend excessive time at underperforming sites while also handling other unrelated projects. Conversely, some sites may exceed expectations, overwhelming CRAs with extensive data verification and regulatory challenges. Recognizing this industry-wide issue, OTT offers tools to dynamically adjust headcount from underperforming to overperforming sites. Through seamless integration with EDC/CTMS systems, OTT accurately forecasts future workload for CRAs at their assigned sites, both on-site and remotely.
Creating a balanced workload
When junior CRAs enter the workforce, OTT employs a skills matrix function to evaluate their therapeutic area and operational skill sets. This approach considers any skills deficit among junior or new CRAs, providing support and ensuring a smoother transition.
By optimizing capacity, including regulatory considerations, and utilizing the JIT algorithm for dynamic resource allocation, OTT significantly improves monitoring efficiency, enabling trials to stay on schedule and reducing costs. As workload distribution becomes more balanced, turnover rates will improve.
The Power of Proactive Measures: Strengthening Data Quality and Safety for CRAs
OTT’s Just-in-Time approach to monitoring surpasses current methods in terms of safety and data flow. Unlike traditional models where CRAs visit sites every 4-8 weeks and work with outdated data, OTT’s REST API integration ensures real-time monitoring and generates intelligent alerts. This proactive approach enables CRAs to address issues promptly, improving data quality and safety. OTT can also detect delays in data entry into the EDC system or the need for CRA verification, providing real-time visibility at the trial and site levels without utilizing any personally identifiable health information (PHI).
In summary, OTT’s modules provide optimized capacity management, comprehensive site support, and workload balancing to prevent burnout and turnover among CRAs. With its real-time oversight and proactive monitoring approach, OTT enhances trial efficiency, safety, and data quality.
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