With the exponential growth in biotechnology product development, it follows that there is a corresponding increase in biotech clinical trial experience. However, despite this increase in experience, biotech clinical development continues to be a challenging exercise, particularly anticipating the regulatory requirements for gaining approval to conduct a trial and later the clinical requirements for marketing approval.
Stuart Mudge, Emmanuelle Voisin
2003 – Applied Clinical trials
Biotech Clinical Development in European Union : Anticipating the regulatory hurdles