Why is Clinical Research Becoming More Bureaucratic?

Why is Clinical Research Becoming More Bureaucratic?

Simon Rule and Steven LeGouill recently authored “Bureaucracy is strangling clinical research.” They note that despite no material change in the law or general GcP practices, there has been an exponential growth in the administrative burden, paperwork and regulation...
Australia TGA Plans GCP Inspection Program

Australia TGA Plans GCP Inspection Program

Australia’s Therapeutic Goods Administration (TGA) plans a GCP inspection program to support Australia’s position as a high quality worldwide hub for clinical research.  TGA is Australia’s regulatory body for therapeutic goods (medicines, medical devices, gene...

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