ArisGlobal, with offices in the U.K. and Connecticut, has a new release of its SafetyMart product. SafetyMart, a data mining and signal detection system, sits on top of a data warehouse. Aris believes its product will shrink the time required to analyze safety data, allowing users to work with their own data, performing drill-down analyses and test hypotheses without calling up a statistician.
Simon Sparkes is the VP of global sales and marketing at ArisGlobal. He notes that regulatory changes, not just lawsuits, are driving demand for drug safety software. European and U.S. regulators are issuing guidelines or regulations that may have substantial effects on the minimal systems needed to monitor drug safety.
In Europe, since last November, the operative regulation is 726/2004/EC. In the U.S., FDA guidelines about Risk Minimization Action Plans (RiskMAPS) are also taking shape. In both regulatory landscapes, the pharmaceutical industry may be obligated to undertake both reactive and prospective safety analyses that were once anything but routine. Says Sparkes: " You can have all the plans in the world, but what you really need is tools to support the data."
Which is where SafetyMart fits in. Using software "wizards" that easily anticipate the most common tasks, SafetyMart lets epidemiologists, physicians, and other nonstatisticians drill down into their safety data and try to figure out if there is a signal amid the din. "You don't have to be a SAS programmer to analyze the data," Sparkes notes. "You can predict potential signals even if there are low volumes of data."
SafetyMart runs atop of a data warehouse-a warehouse that might or might not also have been built by ArisGlobal. SafetyMart easily generates ad-hoc queries, creates reports, and writes summary annual safety reports (ASRs) and periodic safety update reports (PSURs). That could mean faster responses in a crisis. The assumption, of course, is that this is your own organization's data. But as an option, SafetyMart can also be configured to analyze the FDA's own data, available via the Freedom of Information Act.
As impressive as modern drug-safety-analysis tools are, Sparkes says, the industry has not adopted them in general: "It's very early days. Many companies have not undertaken or implemented tools. They have very basic rudimentary signal detection practices."
In some ways, Sparkes says, drug safety applications and databases are similar to insurance policies, mitigating the downside risk of a drug safety issue at a modest cost. If you have crisis without such a system, it's too late. ArisGlobal has been growing nicely, not just because of flagship customers like Pfizer and Boehringer Ingelheim.
Sparkes, like many industry observers, feels that safety data has a higher profile and that such a profile may not diminish soon. "A lot of companies are expecting a significant increase in the number of safety reports because of all the proactive safety reports that have to happen. In order to manage that, we are being pushed to support electronic data capture (EDC) and integrate those with our safety systems."
But Sparkes dismisses the notion-expounded by some in the EDC industry-that EDC tools might eventually make safety applications obsolete. He thinks managing cases-individual reports of a suspected issue with a drug-is too important, and too complex.
But even Sparkes is quick to stress the importance of the judicious use of human intellect to resolve drug safety issues. "Our tools can present data to the users," he says. "It's still up to the users to analyze the data. The tools will highlight potential areas of concern that potentially require further investigation."