On-Demand Regulatory Intelligence.
Clinivation WorldView is the medical device and diagnostic industry’s most comprehensive, authoritative, and up-to-date enterprise solution for On-Demand Global Regulatory Intelligence.
Providing clear, step-by-step market clearance regulations, processes, and guidance for more than 150 countries, clinivation WorldView liberates revenue that’s trapped-in-process, enables submissions sooner, and empowers teams to win.
Ever-Increasing Challenges of Execution, Effective Governance, and Industry Consolidation.
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.
Clinivation WorldView: Optimized for MedTech to Accelerate the Market Clearance Cycle.
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.
LIBERATE TRAPPED REVENUE.
Timely resolution of market clearance process issues accelerates mission-critical decisions, submissions, approvals, and revenue.
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GET IT DONE RIGHT- THE FIRST TIME.
Overcome information conflicts from sales-focused distributors, newly-appointed foreign regulators, and legacy resources.
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EMPOWER YOUR TEAMS TO WIN.
Successfully challenge requests for extensive testing, trials, and samples with facts and statements directly from the regulators.
COMPREHENSIVE INTELLIGENCE FOR ROBUST SUBMISSIONS
To address ever-increasing challenges of execution, governance, and industry consolidation, clinivation WorldView enterprise delivers the industry’s most comprehensive, authoritative, and up-to-date regulatory intelligence into the day-to-day activities of global market clearance operations.
And for complex questions about your specific product situation, we offer clinivation WorldView Professional Support for Client-Directed Case Research.
The clinivation WorldView dossiers include a core Global Regulatory Intelligence Report- written in clear, step-by-step language- plus, as available, translated laws and regulations, forms, templates, and more.
- Comprehensive Regional and Country Coverage addressing more than 150 countries and >99% of the world medtech markets.
- Country-Specific Core Regulatory Intelligence Dossiers addressing: Governing regulatory authorities; Applicable laws and regulations; Product classification schema; Clinical trial requirements; Product labeling requirements; Key compliance requirements; Product registration processes; Submission content and format; Submission review processes; Post-market vigilance requirements; Adverse event reporting; Import and export requirements; Establishment registration; Upcoming regulatory events; Key regulator contact information; and more.
- On-Demand Means Simple Administration with no software to install or maintain.
- Individually-Licensed Downloads for Superior Productivity enable subscribers to work offline- while traveling, for example- and synchronize information when network access is most efficient.
- Seamless Integration with the clinivation Global Market Clearance Platform to unify global market clearance operations into a single management system that delivers comprehensive global regulatory intelligence into day-to-day activities- as required by contemporary corporate governance practices.
