May 13, 2016 | The Clinical Informatics News Best Practices Awards program recognizes outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations that manifestly improve the clinical trial process. This year, a team of expert judges evaluated submissions to the program and announced ten finalists. Three grand prize winners were named at the 2016 Summit for Clinical Ops Executives event in Miami, Florida. We have invited the 2016 finalists to present the projects that so impressed our judges in hopes that these best practices can make wide-reaching impacts on the industry. 

--Allison Proffitt, Editor

PPD developed Preclarus with a cross-functional team of in-house experts from its clinical development, operations, technology and process improvement departments. Our team addressed a key challenge of clinical trials — the collection of large amounts of data often housed in different systems that do not integrate easily. PPD created Preclarus to empower study sponsors to rapidly explore and share information to generate deeper insights to guide the research process.

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 15,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

As a global leader in clinical development, PPD is advancing clinical research with Preclarus, its award-winning, comprehensive clinical data portfolio solution that consolidates and standardizes data from multiple sources. It is also the people, the process and the organization behind the data. Researchers at PPD wrote an article for Drug Discovery and Development explaining how the visualization tools of Preclarus allowed researchers to significantly reduce the review time of medical monitoring. Preclarus brings real-time access to study data, together with the transparent reporting and analytic capabilities needed to make critical study decisions. Preclarus gives PPD teams and clients transparent, real-time access to all clinical trial, patient, and laboratory information. Preclarus dashboards provide interactive visualizations and sophisticated analytics that enable innovative research approaches, driving informed decision-making and facilitating efficiency. It turns data into actionable intelligence.

When observing adverse events in a clinical trial, clinical researchers engage in an ongoing process of detection to protect patients. Traditional clinical trial safety assessment requires time-consuming data collection and review. Manual actions and review may add additional labor-intensive steps, and the cross-functional process often creates multiple listings.

In comparison to the traditional way of conducting safety surveillance, utilizing Preclarus requires minimal additional programming, data management or biostatistical issues. In terms of medical monitoring, the review took 50 percent less time than if the review had been done utilizing multiple listings.

During drug development, it is critical that pharmaceutical companies closely review and recognize the safety of their products. Moving from time-intensive, traditional methods to the use of a visualization tool to review standardized data ensures that companies are better able to focus on the essential goal of quickly delivering safe, life-saving therapies to patients. Using a data visualization tool can cut review time in half, saving time and money.

Preclarus is a powerful tool, providing data integration, predictive analytics, transparency and an unprecedented reporting scope that exceeds functional-based study reporting. Business logic is embedded within the dashboards and online portals to make visible the essential decision-making criteria needed to conduct a successful trial. The tools within Preclarus function as highly efficient workspaces to analyze and share vital information among clinical sites, PPD, clients, vendors and PPD Laboratories. Preclarus consolidates large amounts of trial data and allows users to explore data more quickly and generate deeper insights to guide the research process. 

The dashboards: 

• Address the needs of sponsor staff engaged directly in study level oversight
• Allow holistic oversight of study, country and site startup, and patient recruitment and monitoring activities
• Provide visibility into startup, maintenance and closeout progress
• Present progress within the context of contracted expectations
• Surface potential risk factors
• Consolidate and standardize patient data from multiple sources
• Provide study teams access to all clinical patient data
• Present data in real-time
• Allow evaluation of safety profiles across a project; highlight data trends
• Provide comprehensive review of key performance indicators
• Report detailed, executive roll-up metrics and provide granular detail views
• Reveal metrics on milestones and progress on contractual requirements
• Offer ability to export data and visualizations

Combining the use of analytical data reports with efficient processes for turning those reports into actionable findings, Preclarus provides early recognition of trends, early identification of risks, and more immediate, effective decisions and actions to improve study quality and efficiency. Preclarus dashboards offer real-time, interactive visualizations and analytics that let users drill down into data for detailed information. Preclarus users can filter and mark specific data points and view the details behind data visualizations through the interactive dashboards.

This transparency supports greater operational efficiency as well as closer, more strategic collaborations across teams. The range of expertise and viewpoints contributed by team members during the collaborative process contributes to the development of more profound insights, more effective problem-solving and more overall operational efficiency.

From PPD’s comprehensive data package to specific applications based on Preclarus, PPD tailors data solutions to deliver the right information to the right people at the right time to inform decisions and optimize clinical evaluation.

Capturing, sorting, mining and utilizing data across multiple levels of clinical research — in real time — is at the forefront of technology trends. Ongoing access to scientific and operational data helps our biopharma customers address issues quickly and efficiently to make faster strategic and tactical conclusions about studies. As the industry trends toward adaptive trial design, risk-based monitoring, and mobile health deploying real-time data and analysis capabilities is vital to successful execution of those strategies.

Preclarus allows the seamless flow of integrated, real-time data through all stages of clinical research, providing clients with real-time accessibility. This — and the improved interactive dashboards — enables enhanced, timelier decision-making during the clinical development process, driving efficiencies for important research initiatives.