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Press Release: ArisGlobal Software and Technologies Enhance Pharmacovigilance Compliance and Efficiency at Merck KGaA

ArisGlobal continues to support Merck KGaA, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in providing software and technology upgrades that further enhance pharmacovigilance compliance and efficiency. These upgrades reflect the commitment of Merck Serono to patient safety as a core priority.

Recently, Merck KGaA launched ArisGlobal’s E2B(R3) compliant solution and safety software suite, moving from ARISg 5 to ARISg 7, which offers the latest level of compliance as well as new process and productivity features for affiliates and headquarters alike. Merck KGaA has also been a pivotal member of the ArisGlobal Industry Standard Practice initiative, which has resulted in improved tools and standardized configurations, implemented in ARISg 7.

Merck KGaA also newly implemented ArisGlobal’s module Inbound Receipt and Tracking (IRT). IRT provides a secure and efficient mechanism for global collection of data from call centers, affiliates, CROs, healthcare providers, patient support programs, etc. IRT has improved Merck KGaA’s efficiency, as the company can now take safety reports directly from the call center via their customer relationship management (CRM) software and send them through IRT to ARISg. This allows Merck Serono to process reports within minutes of receipt, which helps further improve compliance.

With ArisGlobal software, Merck KGaA also integrated directly other sources of safety information: Merck KGaA partnered with their largest clinical research organization (CRO) and started a pilot for electronic exchange from their electronic data capture (EDC) system: Data entered by the investigators for their pivotal clinical trials now transfers directly into ARISg. Similarly, Merck KGaA connected their largest patient support program (PSP), MS LifeLines, to ARISg, via a direct data exchange.

Dr. Hans- Jörg Römming, Senior Director, Head of Global Drug Safety Operations at Merck KGaA noted, “We anticipate extraordinary benefits, including significant cost savings, relating to case processing and data reconciliation, especially once these solutions are applied to all clinical trials and patient support programs worldwide. Local drug safety offices in USA, Canada, Brazil, France, Japan and Sweden have already been connected and the full roll-out will continue through 2015.”

“Pharmacovigilance is a business-critical discipline in a heavily-regulated environment. Change management in such an environment always demands the strictest adherence to project planning and professional levels of execution. It was a pleasure to be involved with Merck KGaA,” said Sonia Veluchamy, Managing Director at ArisGlobal.

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