Written by Seamus Kelleher.
Misrepresentation or inaccurate pharmaceutical labeling is a complex issue with serious consequences for patients and pharma companies alike. The implications can be severe, and may lead to deaths, hospitalizations or at the very least, costly lawsuits and fines. Ensuring global regulatory compliance by making sure labels are accurate is a daunting challenge to global pharmaceutical companies. Auditgraph in Columbus, Ohio, developed a technology solution to simplify and streamline this complex and extremely vital process.
“Regulatory compliance is a vital process with serious implications for everyone involved, and there really was no effective solution,” said Mauricha Marcussen, CEO of Auditgraph. “Before, it would take an average of 200 hours to compare one company’s core data sheet, the place where they publish drug information and relevant clinical studies, to a single local label. So that’s 200 hours for Japan’s label, another 200 hours for Brazil’s, and so on. The biggest drugs are in over 100 countries, so you can do the math. This process was extremely inefficient and we saw an opportunity to improve it.”
ComplianceView™ is Auditgraph’s flagship software, described by Marcussen as a “Compliance Intelligence as a Service.” The cloud-based software applies rule-based, mathematical algorithms and methodologies to compare and contrast compliance content, such as labeling info and country-specific regulations, and spot any discrepancies. Discrepancies are then automatically flagged, assessed and ranked in order of severity and importance. That information can easily be shared with the pharma company, who can take action and prevent compliance or health issues.
Marcussen founded Auditgraph in 2011 to address an issue she had become very familiar with during her career as a biologist at the FDA, and then later in electronic publishing for a pharmaceutical company. Today, the innovative software is employed by many of the biggest pharmaceutical companies in the world including Abbott, Auditgraph’s flagship client. Big pharma companies value its ability to sift through big data in a fraction of the time it takes compliance officers to perform the same task manually. With this increased efficiency, users can shift their focus to optimizing other processes, representing huge cost savings.
Auditgraph is a member of Innovate New Albany, a startup incubator run by Rev1 Ventures and a central Ohio regional partner of Ohio Third Frontier. Innovate New Albany provides assistance to high-growth companies by way of mentorship, office space and access to a broad network of venture capital and other funding opportunities. Auditgraph has been part of the incubator since 2013, and Marcussen is an active member. She’s spoken frequently to entrepreneurs and university students about her experiences starting and growing a successful company in Ohio.
“The advice I always give to people looking to start a business is to dive head first into a problem you’re close to, something you’re familiar with and develop the solution to that problem,” said Marcussen. “When you invest your effort into something you’re familiar with and passionate about, plus you’ve got a support system like the one we have in Ohio, you have a great chance to succeed.”