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.

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