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Adopting label change best practice to promote clarity and compliance
Globalised clinical trials are quickly becoming a pre-requisite for success. This enables sponsors to spread the risks associated with unpredictable patient enrolment by taking advantage of the larger patient pools and population diversity on offer, while simultaneously driving down costs and expediating study timelines.
The benefits of extending clinical trials outside of traditional study locations in favour of emerging regions are obvious. Yet the complexity of assuring compliant and timely supply to patients across hundreds of clinical sites, spread over multiple countries, can result in additional burden for sponsors to shoulder. The penalty of failing to appropriately manage this additional complexity not only limits sponsors’ ability to capitalise on the potential benefits of global trials, but also increases the risk of negatively impacting patients and compromising compliance.
A by-product of operating global trials is the constant evolution of study protocols, as sponsors grapple with accommodating new countries with specific demands. The knock-on effect such changes and updates have on clinical labelling functions can be significant.
As one sponsor recently discovered, without effective processes in place or capable suppliers to hand, failing to manage label change appropriately against challenging timelines can quickly become an unwelcome reality.
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