Regulatory Affairs
Strategic Regulatory Consulting and Submissions
Clinical Trial Regulatory Affairs
Safety
Clinical Safety
Post-marketing Safety
Risk Management Plans
Endpoint Adjudication

 


Safety to meet market imperatives


Timely collection, analysis and reporting of accurate drug safety data from clinical studies and marketed products is not only a regulatory requirement but also a vital strategic need. Kendle’s team of 140+ safety experts crosses every global region, harnessing local safety expertise from doctors, nurses, pharmacists and degreed life scientists, as well as data-entry specialists. The team works closely with Kendle’s Medical Affairs group, reviewing adverse events (AEs) and providing our customers with comprehensive medical monitoring and safety services.

Because we are globally connected, we can help you overcome the geographical and language issues inherent with large international projects. We have centers of excellence in nine locations around the world and can localize a global strategy to meet individual country regulations and reporting requirements. Our local experts have a thorough understanding of the particular requirements for safety data reporting in their own regions and have access to Kendle’s global safety database, allowing them to process data anywhere in the world.



 

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