Quintiles, the world’s largest life science services company, is adding predictive analytics based on proprietary algorithms to its risk-based monitoring suite for clients seeking to develop drugs less expensively and faster through software solutions that can predict outcomes and potential safety issues.
The Durham-based company is unveiling its new tools at the Drug Information Association conference today in Washington, D.C.
Quintiles (NYSE: Q) believes it is the first company to offer risk-based monitoring, or RBM, that includes predictive analytics capabilities. It’s calling the addition “Predictive and Advanced Analytics.” Quintiles has to date conducted more than 130 drug development studies utilizing RBM, involving 260,000 patients.
“To our knowledge, no other biopharmaceutical services provider currently offers a risk-based monitoring (RBM) solution that includes functionality to predict clinical trial site performance and identify potential patient safety issues before they occur,” says Phil Bridges, senior director for Corporate Communications, an Quintiles.
“Currently, risk mitigation in any RBM model is triggered after an event occurs. The integration of Predictive and Advanced Analytics capabilities into Quintiles’ risk-based monitoring (RBM) solution will help increase the efficiency of drug development while improving quality and patient safety.”
Quintiles is incorporating the new capabilities into its Infosario technology platform for drug development.
The new tools are intended to “improve precision in risk identification by better understanding underlying ‘white noise’ from safety trigger processes,” the company says.
“The ultimate goal of risk-based monitoring is to increase the efficiency of drug development while improving quality and patient safety,” said Margaret Keegan, senior vice president of Data Sciences & Strategy at Quintiles. “The ability to cut through all the noise and predict potential risks before they occur means we can target the right action at the right place at the right time. It is a major step forward in improving quality and productivity in the next generation of RBM execution.”
Inside the new service
In a Q&A with Quintiles, WTW sought more details about the new service and why it’s being offered now.
- What were the “pain points” to address for clients that led to this?
As clinical trials continue to become more complex and technology continues to evolve, risk-based monitoring (RBM) adoption continues to increase across the industry as biopharmaceutical companies want to increase data quality and reduce the costs associated with on-site source data verification (SDV).
According to a recent industry survey*, upwards of 50 percent of respondents were using RBM across their clinical trial programs or on a pilot basis supported by centralized data analytics, compared to 33 percent of respondents in 2009. In addition, 10 percent to 30 percent of respondents in the 2014 survey that are not currently implementing any of the various RBM strategies claimed that they are planning to do so within 12 months.
In addition to gaining time and cost efficiencies by deploying RBM and a centralized monitoring approach (versus regular onsite clinical trial monitoring that is more time-consuming and can be more costly), the new Predictive and Advanced Analytics component provides the ability to predict potential risks before they occur. As a result, customers can target the right course of action at the right place at the right time. This is a major step forward in the evolution of RBM to help speed drug development while improving quality and patient safety.
(*:Taking the Risk: An Examination of Current Organizational Approaches and e-Data Sources Driving Risk-Based Monitoring Programs. Risk Based Monitoring Full Report, 2014. Metrics Champion Consortium. 2014.)
- Is the service a response in part to customer requests Why do this now?
We have begun implementation on RBM studies. We have done initial modeling through prototypes and have seen significant positive results. We will be implementing Predictive and Advanced Analytics on more RBM studies in the coming year based on specific customer preferences.
Clinical trials are becoming more and more complex and technology continues to evolve. The adoption of risk-based monitoring (RBM) continues to increase across the industry as customers have a need to increase data quality and reduce the costs associated with on-site source data verification (SDV). The ability to cut through the white noise and predict potential risks before they occur means we can target the right action at the right place at the right time.
The proprietary analytics and algorithms help study teams better predict clinical trial site performance and identify potential patient safety issues so they can intervene before a less typical pattern of adverse event occurs. These interventions can help to protect the patient as well as the study.
Once the results from the predictive algorithms are validated, Quintiles renders a dashboard in a visualization tool to provide customers with the insights they need to make swift, informed decisions. The dashboard also includes the advanced statistical monitoring data