Theorem Clinical Research, Emergo Group Form Strategic Relationship

Theorem Clinical Research

and

Emergo Group

have formed a strategic relationship 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 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 leading regulatory consultancy with more than 2,500 medical device and in vitro diagnostic device (IVD) clients and has offices offering a wide range of

compliance and market access services

in 25 countries. Emergo Group assists companies with 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 is a leading contract research organization specializing 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.”