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Internal, external collaboration helps ensure global coverage
Clinical trials occurring across the globe "have blown up into the most enormous headache for risk managers in the pharmaceutical industry," says Scott P. Borup, Johnson & Johnson's director of corporate risk management.
Efforts to soothe the headache for the New Brunswick, N.J. -based company require close collaboration between Johnson & Johnson's risk management department, its liability broker and insurer, and its clinical trial department to ensure the timely issuance of about 2,000 insurance certificates annually across several continents.
"If the clinical trial is taking place in the Ukraine, the certificate of insurance has to be written on a Ukraine clinical trial certificate form," Mr. Borup said. "It has to be through an insurance company licensed in the Ukraine and the certificate needs to be in the local language."
Producing insurance certificates is a complex process because governments have established "extremely rigorous" requirements for clinical trial...