From CPHI India
Eager-to-please Indian manufacturers creating GMP chaos says expert
Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.
Archives for December 8, 2014
INC Research expands partnership with Society for Clinical Research Sites
INC Research has expanded its partnership with the Society for Clinical Research Sites (SCRS) through the end of 2015 to become the first organization to support SCRS' new member Scholarship Program as well as the first CRO to establish a Site Advocacy...
FDA to allow paper or electronic transaction info transfers under DSCSA
New draft guidance from the US FDA related to track-and-trace legislation facilitates the transfer of both paper and electronic accounts of transaction info, history and statements for manufacturers, repackagers and wholesale distributors.
Biorasi pushes into Western Europe with ABR acquisition
CRO Biorasi has acquired fellow CRO Advanced Biosciences Research (ABR) to expand its operations in the UK, Germany, Switzerland, and Sweden.
Germany suspends drugs trialled by GVK Bio due to ongoing data falsification concerns
The EMA may withdraw marketing authorisation for generic drugs trialled by GVK Biosciences next month, after German regulators suspended several products and launched a review of alleged data manipulation by the CRO.
CRO employee turnover rate falls as industry matures, survey finds
Over the last three years US turnover in clinical monitoring has dropped from 29.4% to 16.4% and globally overall company turnover has dropped from 27.2% to 14.2% on average, according to the 16th annual CRO Industry Global Compensation and Turnover Survey.