Addressing Site Issues in Near Real-Time

Gain visibility and make data-backed decisions with our site performance dashboard

Running a clinical trial is a long and tumultuous process requiring trial sites and sponsors to sift through various challenges. Identifying, preempting and overcoming emerging issues and bottlenecks, reducing site burden, and improving the overall efficiency of a trial through continued improvements are just a few examples.

Preventing these issues is difficult without proper clinical trial monitoring and visualization. A solution that generates deeper insights to guide the research process and inform decision-making at the study and site levels is critical.

PPD Preclarus™ lab solutions do just that. The Preclarus central lab database, our proprietary enterprise and information management system, provides integrated data to project teams in real time to inform decisions. Preclarus dashboards deliver unprecedented reporting scope that exceeds functional-based study reporting and integrates data collected from three main areas — the laboratory, the operations team and the clinical trial site.

Challenges faced by sponsors and sites running clinical trials

Clinical trials are a complex, high-stakes game. Sponsors and sites may run into a multitude of challenges that can significantly hinder clinical trial progress.

A site’s ability to accurately screen and enroll clinical trial patients can significantly affect the progress of a clinical trial. Clinical trial staff should be well-versed in protocol requirements set by sponsors. But these vary based on the site and study, adding to the complexity of running a successful clinical trial. As such, identifying and correcting issues at the study and site level is critical.

Using lab data to help sponsors proactively manage their sites can identify opportunities to improve performance early in the trial that could slow down the drug development process, which would otherwise cost the sponsor both time and money. With the right tool, clinical trial sites, sponsors, clinical research associates (CRAs) and clinical trial managers (CTMs) can more efficiently monitor clinical trials.

The Preclarus Site Performance Dashboard helps sponsors monitor and drive compliance at the study and site level

Preclarus dashboards offer interactive visualizations of operational, patient and lab data that are powered by advanced analytic capabilities to give research teams the ability to identify trends and drill down into the data for more detailed information. Business logic embedded within the dashboards make visible the essential decision-making criteria to conduct a successful trial. Preclarus users create customized dashboard views to filter and mark specific data points and see the details behind data visualizations.

One of the many components of the Preclarus solution is the Site Performance Dashboard, developed and refined based on customer feedback. This clinically focused, best-in-class tool enables clinical teams to visualize and monitor site activities through a comprehensive, data-driven approach, intended to improve site performance. The insights provided will enable CRAs and CTMs to quickly identify inefficiencies, compliance issues associated to data entry, kit utilization and sample collection/handling resulting in test cancellations, while trending the data to measure improvement.

More specifically, the Site Performance Dashboard:

• Provides an opportunity for near real-time monitoring, allowing CRAs and CTMs to gain visibility of sites, communicate with sponsors and resolve issues before they arise, which results in more proactive data resolution, improved data quality and clinical trial efficiency.
• Helps sponsors gain visibility to identify problem areas (preempting further problems downstream), bolster compliance, track performance metrics and improve site performance.
• Helps sites make informed, data-backed decisions and identify trends in query types.
• Track electronic requisition (e-req) usage which significantly reduces the number of queries and site burden.
• Enables teams to assess where additional training (or retraining) is required.
• Helps trial managers effectively distribute workloads, identify areas of improvement, discover worrying trends (like shipments consistently being delivered at the wrong temperatures) and streamline processes.
• Identifies trends to improve clinical trial efficiency.

CRAs and CTMs will be able to leverage the analytics provided to retrain sites and use the trending data to measure performance improvement. The dashboard helps trial sites aggregate, analyze and present data to manage site burden and optimize sample oversight.

Gain near real-time visibility of clinical trials with PPD Preclarus Site Performance Dashboard

The Preclarus Site Performance Dashboard allows comparative evaluation of sites in real time, enabling sites and sponsors to continually refine processes and ensure current and future clinical trials run as smoothly and efficiently as possible.