Emerging leader in medical devices for gastrointestinal and metabolic diseases selects clinivation enterprise solutions for accelerated global market access and comprehensive global regulatory intelligence.
NATICK, MA – April 2, 2012 – Clinivation, Inc. is pleased to announce today that Enteromedics has selected clinivation enterprise solutions for accelerated market access and comprehensive global regulatory intelligence.
Ever-proliferating and changing global regulations generate complex challenges of execution in global market clearance operations.
Mission-critical decisions are delayed, trapping new international revenue until market clearance process issues are resolved. Workflow is confounded as information conflicts from sales-focused distributors, newly-appointed foreign regulators, and legacy resources are reconciled- and as definitive answers are sought. Governance is compromised as information gaps reduce assurance levels and impair risk management of clearance-related penalties, fines, and legal costs.
And the high level of business performance required to create value from ongoing medtech industry consolidation is not achievable, since global market clearance operations are incapable of rapidly completing new market clearance submissions for newly-acquired product lines.
Unlike repackaged RI databases designed for the pharmaceutical industry, the clinivation WorldView Enterprise Solution for On-Demand Global Regulatory Intelligence accelerates the market clearance cycle.
This is because clinivation WorldView is designed, optimized, and proven to accelerate the processes and workflow specific to the global market clearance operations for medical devices, diagnostics, hospital supplies, and dental supplies.
And the industry results are outstanding. In multiple customer impact studies, clinivation WorldView customers consistently report accelerating submissions by 30 to 90 days, compared to recent experience without clinivation solutions.
For more information on the clinivation Enterprise Solution for On-Demand Global Regulatory Intelligence and Client-Directed Case Research Solutions, please visit the clinivation WorldView homepage.
For more information on the clinivation Enterprise Solution for Global Market Clearance Management, please visit the clinivation Global homepage.
EnteroMedics® Inc. (NASDAQ: ETRM) has developed VBLOC® vagal blocking therapy, a unique, broadly patented therapeutic approach designed to treat a range of gastrointestinal and metabolic diseases. VBLOC Therapy is a first-in-class weight loss treatment designed to help address the growing global health crises associated with obesity and its co-morbidities, such as diabetes and hypertension.