Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question – this month it’s a look at INFECTIOUS DISEASE, regulatory issues and patient enrollment:
We asked ourselves:
Scenario: A Phase III study required by the FDA for approval was stalled at its North America sites and regulatory processes in South America prevented significant contribution to these studies. There were multiple rejections because this infectious disease study required a placebo control. The study recruitment by another CRO was not met in the previous two seasons.
Criterium offered an experienced team in the Southern Hemisphere to get approval by the regulatory authorities of this placebo-controlled respiratory infection study, to extend the recruitment to 10 months of the year and to enroll at a higher rate per site than the previous seasons’ site enrollment rates.
Criterium’s team averaged more patients per site than the Northern Hemisphere at a high compliance rate for the target micro-organisms.
What If: The client could have continued recruiting patients in the Northern Hemisphere winters, thereby further extending the length of the study.
Results: Criterium managed the regulatory process to receive approval for the study on the first agency reviews and accelerated enrollment with its experienced team in South Africa and New Zealand.
Read more of our successful case studies: http://www.criteriuminc.com/case_studies.php
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