Agility and expertise combine to overcome late stage design issues in comparator study

There are multiple points of a clinical trial’s route-map where the success of the study can be derailed. When it comes to sourcing comparator products to effectively assess an Investigational Product’s (IP) performance against the current standard of care, there’s a lot that can go wrong.

For instance, the current global supply shortages in particular therapeutic areas can driveup procurement costs and supply complexity, by forcing sponsors to source product from multiple suppliers and regions. Likewise, if comparator drugs are unexpectedly discontinued, sponsors may be faced with leaving patients in limbo while they update and resubmit the Clinical Trial Authorisation (CTA) to relevant regulatory bodies.

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