CRO Theorem Clinical Research, based in King of Prussia, Penn., has formed a strategic partnership with Emergo Group to provide global regulatory consulting services, including reimbursement consultation and in-country regulatory representation services, to the medical device and in vitro diagnostics community.
“Emergo Group complements our own global strategic regulatory affairs and clinical trial capabilities,” said D. Lee Spurgin Jr., Ph.D., Theorem’s senior vice president and general manager of medical device and diagnostic development. “Working together we can provide more services and a bigger global footprint, so our strategic relationship helps us to be a one-stop provider for our clients.”
Emergo Group is a regulatory consultancy with more than 2,500 medical device and in vitro diagnostic device (IVD) clients and offers a range of compliance and market access services in 25 countries, including global regulatory strategy, device registration, quality management system compliance, in-country regulatory representation and distributor qualification.
With offices in more than 30 countries worldwide, Theorem Clinical Research specializes in the management of complex clinical trials for biopharmaceuticals, medical devices and drug-device combination products.
“The right strategic relationship strengthens both companies,” said Emergo Group president and CEO Rene van de Zande. “We believe the synergy we achieve with Theorem is a benefit to all concerned.”