The European Medicines Agency (EMA) has released a concept paper proposing changes to its current guidance on first-in-human clinical trials.
A recent FDA Advisory Committee vote could allow researchers to use continuous glucose monitoring (CGM) systems in place of traditional methods, providing “a myriad of customized data,” says Quintiles.
According a recent survey, while there is a disconnect between Sponsors and Providers in some areas, the industry as a whole agrees that there is room for improvement.
The acquisition of Compass Research expands Bioclinica’s access to several specialized populations with neurodegenerative disorders and other diseases.
The EMA is recommending the suspension of several medicines after inspections revealed flawed studies at the India-based contract research organization (CRO), Semler Research Centre.
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In globalising the pharmaceutical industry oversight and control has increasingly become a challenge in managing product quality, consumer safety and organisational risk.