Emerging leader endoscopic treatment solutions for Barrett’s esophagus and other gastroenterological diseases selects clinivation enterprise solutions for accelerated global market access and comprehensive global regulatory intelligence.
NATICK, MA – February 18, 2011 – Clinivation, Inc. is pleased to announce today that BARRX Medical 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.
About BARRX Medical:
BARRX Medical, Inc. develops endoscopic treatment solutions for Barrett’s esophagus and other gastroenterological diseases such as esophageal squamous cell neoplasia, bleeding associated with radiation proctopathy, and bleeding associated with gastric antral vascular ectasia. Barrett’s esophagus is a precancerous condition of the lining of the esophagus (swallowing tube) caused by gastroesophageal reflux disease, or GERD, and can lead to esophageal adenocarcinoma. Esophageal squamous cell neoplasia is the precursor to the most common type of esophageal cancer (squamous cell carcinoma), which results in over 400,000 deaths per year worldwide. The company’s HALO90, HALO90 ULTRA and HALO360+ ablation catheters, powered by the HALOFLEX ablation system, provide a uniform and controlled ablation effect, which removes diseased tissue and allows re-growth of normal cells.
Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is privately-held.