Two leading contract research organizations based in the Triangle, Quintiles and PRA Health Sciences, independently announced new analytics technology Monday that they tout will improve the efficiency of clinical trials of experimental drugs.
Quintiles, the world’s largest CRO, said its new Predictive and Advanced Analytics technology will take a holistic approach, looking at numerous factor to help predict how well clinical trial sites will perform and also identifying potential safety issues involving patients.
CROs help drug companies test experimental medicines and analyze the results.
“Our customers need to optimize the development process,” Margaret Keegan, senior vice president of data sciences and strategy at Quintiles, said in a video that the company released in conjunction with its announcement. “Predictive and advanced analytics will bring them the confidence that they can pinpoint where the issues are in their programs and their studies.”
Knowing those issues in advance, said Quintiles spokesman Phil Bridges, will enable drug companies to “make any necessary changes.” That could lead, for example, to a patient being removed or excluded from a clinical trial based on the potential risks identified, although that decision would be made by the clinical trial investigator, who would also take factors such as their clinical assessment into consideration.
The predictive models can aid in making decisions of subject exclusion on studies. The advanced and predictive analytics will highlight patients at potential risk of adverse events or serious adverse events. However, the decision to exclude / remove patients from a trial is based on additional factors including the clinical assessment by the clinical trial investigator.
Keegan said that the technology will be offered in conjunction with Quintiles’ risk-based monitoring services and “really takes risk-based monitoring to the next level.”
Risk-based monitoring is a nontraditional approach to monitoring clinical trials, which is growing in popularity, that calls for allocating resources to where the risk is greatest in clinical trials. Monitoring clinical trials at investigative sites, such as doctor’s offices and hospitals, is one of the most important — and most expensive — pieces of the drug-development process.
Durham-based Quintiles has more than 33,000 employees worldwide, including about 2,500 in the Triangle.
Raleigh-based PRA hailed its new Predictivv platform as a “fully integrated solution for designing, planning and optimizing the management of global clinical studies.”
Predictivv is a series of applications. Among the first is Predictivv Connect, which will enable data analysis “that provides real time insights into every phase of clinical trial management,” PRA said in its announcement.
Upcoming applications will focus on key components of clinical trials such as site selection and patient recruitment.
“Through a proprietary analytics engine,” PRA said, Predictivv will not only provide transparency into all key processes and their statuses, but it will be capable of proactively identifying processes and protocol deviations, enabling course corrections before risks occur.”
PRA officials weren’t immediately available for additional comment on Monday’s announcement.
PRA has more than 11,000 employees worldwide, including more than 450 locally.
The Triangle is the epicenter of the worldwide CRO industry. Three of the world's largest CROs are headquartered here: Quintiles, PRA and INC Research.