Sopharma AD is a leading manufacturer and distributor of high-quality pharmaceuticals in Bulgaria. It also exports to 30 countries, including Russia, the Ukraine, other countries in the Commonwealth of Independent States (CIS), and the European Union (EU) via subsidiaries or partners. Generic medicine accounts for 75% of the company’s revenue and 25% of its sales come from Sopharma-branded products. Sopharma’s product portfolio includes approximately 110 products that span virtually all pharmaceutical and therapeutic groups.
Sopharma wanted to ensure compliance with EU pharmacovigilance legislation after Bulgaria joined the EU in 2007. The company selected Oracle Argus Safety to streamline the collection, monitoring, and evaluation of adverse drug reaction (ADR) data and to share data seamlessly between internal groups, as well as with global license partners, distributors, and regulators.
With Oracle Argus Safety, Sopharma improved its ability to capture ADR data from multiple sources—including patients, doctors, and physicians conducting clinical trials. In addition, the company reduced from 30 minutes to two minutes the average time required by an EU Qualified Person for Pharmacovigilance (QPPV) —an individual responsible for ensuring that a company meets its drug safety monitoring obligations—to generate a report that is ICH E2B-compliant (internationally accepted format for transmitting drug safety data electronically) or a Council for International Organizations of Medical Sciences (CIOMS)-compliant ADR report . Further, Sopharma used Oracle Argus Safety to streamline regulatory approval, enabling it to reduce time to market and increase profitability.
Sopharma chose Oracle Argus Safety for its robust functionality, industry reputation, and ability to scale as the company grows. In addition, Oracle Argus Safety has a modular nature that enables Sopharma to incrementally add new capabilities, such as multidimensional analyses of drug safety data, business intelligence, and management information.
“Pharmacovigilance requirements are the same for all companies, whether they are large multinationals or midsize organizations,” said Dilyana Karaivanova, senior expert medical affairs and pharmacovigilance, deputy qualified person responsible for pharmacovigilance, Sopharma AD. “We selected the market-leading solution to avoid the false economy of purchasing a tier-two product that would not meet our future needs.
“Oracle Argus Safety will also enable us to comply with pharmacovigilance legislation in new European and Asian markets where we plan to extend our presence.
Sopharma AD implemented Oracle Argus Safety and rolled it out to its team of qualified pharmacovigilance experts. The solution’s intuitive functionality ensured rapid adoption by the QPPV team and helped improve productivity.
“Oracle Argus Safety’s easy-to-use interface enabled all team members to get up to speed quickly. The solution’s best-practice processes allow us to focus on analyzing and sharing ADR data, as opposed to spending all of our time processing information,” Karaivanova said.