The clinical development phase continues to represent the most challenging stage of drug development globally, critical to the successful commercialization of new products but posing multiple and complex considerations in terms of trial design, enrollment and outcomes. Failure can prove costly and even critical to the survival of smaller companies heavily reliant on relatively few pipeline assets.
It is crucial that companies get things right. Where do we perform trials to optimize speed and outcomes? Who should lead these? How do we ensure timings fit with our strategic plans and investor and patient expectations?
Against this background, this e-book looks at some of the key issues surrounding clinical development in the Asia region, highlighting several regulatory and policy changes that are influencing the operating environment. The one common thread that emerges is the pace and breadth of change.
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