One curiosity of the drug safety controversies of the past few years is the low profile of most of the software companies in the niche. One could read the newspaper or your favorite business magazines and imagine that the industry didn’t have people or systems to manage and predict adverse events, that Medwatch paperwork and other forms were just being put into shoe boxes and forgotten.

The media shyness of the clinical trial sponsor community is a factor. But so is a certain trepidation at attempting to discuss the math of drug safety.

So we were happy to have a conversation with Relsys, one of the oldest companies in the business. Founded in 1987, with 200 employees, it considers itself the leader in drug safety, with a variety of tools for managing safety reporting and pharmacovigilance. Bruce Palsulich is a safety guru and the Davis, California, company’s chief innovation and strategy officer. He tells us there’s been a change in the industry’s priorities around adverse events reporting.

Beyond the PSUR

Not that long ago, the main goal was simply submitting the most urgently mandated reports. “Compliance is still important,” notes Palsulich. “But that’s shifted to risk management and the benefit-risk profile of your product. Risk management has a lot of visibility.”

Relsys recently updated its core product, Argus Safety, to reflect some of the new obligations around post-marketing commitments and REMS, or risk management evaluation strategies. Here’s a release.

REMS, of course, are an outgrowth of last year’s FDAAA legislation.  Here is an FDA FAQ document on the topic. The first REMS are still being negotiated between sponsors and regulators, Palsulich says, and it’s too early to make generalizations about how they depart from RiskMAPS.

Other Stake holders

Palsulich says the company’s solutions are increasingly well understood beyond the pharmacovigilance department, helping other stake holders—people in regulatory affairs, legal, R&D or manufacturing. The global nature of the industry means the reports often must be coordinated to different international authorities. Finally, there’s the pressure to perform automated triage on safety reports to allow more laser-like attention on the ones that need to be carefully examined by physicians.

The people in drug safety are swamped, and software can help. Says Palsulich: “There is the ability to reevaluate the business process in place and reduce the involvement in medical review and physician-processing of individual cases. If there are 10,000 cases and 1,000 get signaled as alerts, and ten are of some importance, you want [medical professionals] focussed on the ten cases, not the 10,000 cases.”

The company doesn’t customize its software. But it will configure its systems to conform to any business process. “If you can draw it on the white board, and describe the business rules, we can work within that,” Palsulich says.

Audit Ready

Palsulich believes that executives in the sponsor community want ways to assure themselves that an agreed-upon risk management plan was implemented and followed to the letter. Software can provide a level of comfort that the policy was followed.

“Companies are looking toward systems to support their compliance with their risk management plan and be able to describe to an auditor that they have systems in place that allow them to look for specific alerting criteria” he says.

In larger companies, he reports, there is much less attachment to archaic paper and fax-based systems for managing adverse and serious adverse event reports: “At this point, just with the sheer volume of cases, certainly the larger pharmas are having to process, it would just not be feasible. The workload would be too significant.”

Shifting Science

But the shift to technology and electronic sorting of cases means that the safety officials need to place their faith in a system, not a harried physician. And that takes some tire-kicking and inspection of what the software does. “There is a paradigm shift that has to take place in the way they routinely do business,” says Palsulich.

The crux of the matter is fairly simple. To focus on the ten percent of cases demanding human attention, there is significant scrutiny of the algorithms and business rules in any system that handles the other ninety percent of the incoming stream.

Palsulich believes the forthcoming Sentinel system from FDA, which aspires to tap into federal and private databases with information about 100 million Americans, could change the safety landscape in the sponsor community. “If you can look at true exposure rates or look at actual outcomes, positive and negative, the science of evaluating the benefit-risks of drugs is going to shift,” he says.