The focus on technology as a driver of performance improvement in clinical trials is intense, but despite years of valiant efforts; study execution remains far from optimal. For study startup, the data are dismal: contract cycle times have doubled from an industry median of a month and a half in 2009-2011 to more than three months in 2014-2015, 37 percent of sites under-enroll, and 11 percent fail to enroll a single subject. Overall, poor site selection, the inability of sites to predict the rate of enrollment, and the subsequent need for study rescue may increase cost of trials by 20 percent or more.
The continual reliance on spreadsheets, multiple databases, and unsecured email without audit trails is inadequate to manage study startup activities. Overseeing activities from dozens or even hundreds of sites involves tracking and storing country-specific documents, ensuring regulatory and SOP compliance, and identifying bottlenecks as the startup process unfolds. The high degree of complexity results in valuable time wasted trying to find data buried in documents, along with subsequent analyses that are not readily available. In this environment, a multitude of status meetings to understand the results and key metrics that are driving startup performance is routine.
An end-to-end solution with workflows that aggregate data from disparate sources can identify the documents needed to conform to downstream regulatory requirements and can also signal bottlenecks or breakdowns in study execution. This approach helps to avoid rework, delays, and cost overruns, improves cycle times, and facilitates audit readiness. This approach can break down silos that have long performed in isolation with little understanding of what the next department needs to fulfill its regulatory obligations and achieve targets measured by performance metrics.
Oracle Health Sciences offers the only, complete, end-to-end suite of solutions for starting clinical trials, from site identification and feasibility assessment/selection through to activation, with comprehensive metrics to track adherence to timelines and budget. Oracle Health Sciences goBalto Select Cloud Service assists with the identification of high-performing investigative sites by providing a data driven approach to weighing selection and performance variables. This ensures that recruitment is completed on-time, on-budget and that the data is delivered with excellent quality. Study sites can then be seamlessly initiated for subject enrollment using Oracle Health Sciences goBalto Activate Cloud Service, which enhances real-time oversight to clinical operations management by tracking milestones on the critical path and providing document workflow management capabilities in a transparent, regulatory-compliant, and user-friendly way. Advanced and comprehensive reporting capabilities are provided by Oracle Health Sciences goBalto Analyze Cloud Service providing real-time visibility into study startup activities across multiple studies and regions, making it easier to quantify team performance and discover meaningful patterns in study data.
Oracle Health Sciences’ technology provides organizations with an opportunity to rethink the inefficiencies of silos and "think horizontally." This method uses automation and workflows to integrate operational data across all functions, making it easier to extract meaningful insights from those data. Bringing interdependent functions together using technology and critical teams helps to navigate the highly complicated global regulatory maze.
As the arduous task of dismantling silos begins, there is a growing recognition that technology is critical. Without it, sponsors and contract research organizations (CROs) will continue to experience the measurable ramifications of poor quality, including delays, cost overruns, poor communication, and lack of audit preparedness. These problems can be avoided with the expanded use of workflow-based tools and performance metrics. By embracing this approach, complemented by support from key decision makers, it is possible to move the needle on process change, increase the likelihood of more predictable cycle times, better adherence to study budgets, and audit readiness.