How can a company that specializes in drug labeling gain insights from a financial-services or manufacturing company?
It may seem unlikely, but the special sauce of the Columbus Region's IT community allows for unexpected collaborations.
New Albany-based Auditgraph, which drives global patient safety by ensuring drug labels are updated in a timely and accurate manner, has partnered with a wide variety of area organizations: Columbus 2020, Rev1 Ventures, The Ohio State University, Innovate New Albany, Cardinal Health Fuse, Otterbein University, Ohio Northern University, TechOhio and the Lachey Company.
“The advantage is a network of IT collaborations which help us grow our product focus,” CEO Mauricha Marcussen says. “Columbus is a community where people are willing to share ideas and information about IT operations.”
That local network has allowed Auditgraph to grow its business to a global scale.
The company's local team supports operations in four locations in North America and two in Europe.
Beyond simply the ability to collaborate, the Columbus Region offers best-in-class financial and mentoring resources for quickly growing companies. Auditgraph, for example, scaled at a business incubator in New Albany, Inc@8000.
The drug labeling company provides expertise for managing all aspects of a company's labeling program, for prescription drugs, generic drugs, medical devices, consumer products and related patient information.
Various countries and regions of the world have different templates and requirements for local and corporate labeling.
“While US regulations currently require the labeling on generic medicines to be identical to their brand-name equivalents, in reality the vast majority of generic drugs carry labels that differ from the branded products,” Auditgraph notes on its website. “There are critical safety concerns of disparate labeling between the branded and generic labels.”
Labeling is important because it describes proper use of the product and describes safety and efficacy to humans, ultimately improving global patient safety.
Drugmakers have to make sure they are up to speed on the latest emerging regulations. If labeling isn't globally compliant, it will be hamstrung.
“Our experts will provide key considerations for developing a strategic approach to implementing the Company Core Data Sheet safety changes into country-specific labeling submissions,” Auditgraph says on its website.
Auditgraph uses its proprietary ComplianceView software to handle global product labeling compliance. The platform efficiently assesses, reports and tracks critical safety differences between the Company Core Data Sheet—essentially a drugmaker's own product description—and thousands of local country labels. It identifies labeling deviations quickly to both improve internal efficiency and to meet stringent government requirements.
Marcussen says the privately held Auditgraph, founded in 2003, will have to leverage new technologies to assist clients in the future.
“Our challenge going forward is to determine how machine learning and artificial intelligence can be incorporated into our ComplianceView technology to further drive our goal to improve global patient safety,” Marcussen says.