Faced with concerns such as increased regulatory scrutiny, the increasing number and complexity of
clinical trials, post-marketing commitments, a narrowing drug development pipeline, resource
constraints and increased costs, all sponsors of clinical trials are looking to reduce drug development
costs by enhancing overall efficiency.
Clinical trial costs continue to spiral and often are the result of poor or ‘optimistic’ planning, which is
unable to take into consideration some of the real-life experiences. It is a common expectation that
most sites will fail to meet their enrollment rates and many studies will need to be extended way
beyond expected timelines. Failing to plan for such occurrences and have suitable mitigation and
corrective plans is often a critical failure.