Premier Research was contracted by a global pharmaceutical company to manage all aspects of a large seven-year Phase 3b pan-European trial to study if an angiotensin II receptor blocker can prevent the onset of microalbuminuria in subjects with type II diabetes.
Working with 283 sites in 19 countries throughout Europe, Premier Research was able to meet the patient recruitment timeline and successfully recruit 4,557 patients in 21 months. While only 60% of the sites were located in CEE countries, over 80% of the patients were enrolled at these centers, with the highest enrollment rates yielded from the sites in Ukraine, Hungary, Romania and Bulgaria.
One particular challenge for this study is that more than 1,000 SAEs are expected. Premier Research has provided centralized medical and safety support in Germany through an assigned medical and drug safety advisor with reporting requirements supported by local drug safety representatives in our local offices. We have been successfully managing the SAEs by ensuring the SAE processing is completed using a chronologically ordered template system and employing an automatic fax distribution system for SUSAR distribution. To date, more than 500 SAEs have been processed by Premier Research.
This profiles one study in a series of 27 trials where Premier Research provided services during the development of the investigational medicinal product. For 24 of these clinical trials, Premier Research provided full clinical services. This represents the majority of the trials leading to successful authorization in many European countries and the United States.