More and more Language Services Providers (LSPs) are entering the regulatory area who, in turn, outsource this work to their in-country network. The people who actually do the label review are removed from the pharmaceutical company or CRO by up to four degrees and the end-client has no visibility at all of who is doing this work.
Read MoreThe complexity of the regulatory approval process for labels increases with each clinical phase, as patient numbers increase, from 10-20 patients in Phase 1 to 100-200 people in Phase II, to as many as 10 000 patients in a Phase III trial. As many Phase III trials are conducted across an increasing number of countries, the complexity of dealing with multiple regulatory agencies is magnified.
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