QPS has been assisting an international Sponsor to perform a global, late-phase study to investigate the safety, efficacy, and pharmacokinetic behavior of a newly formulated investigational drug in subjects with advanced prostate carcinoma.
The original enrollment goal was 133 patients to be enrolled in approximately 18 months. The QPS Global Clinical Operations team enrolled 137 patients at 30 sites in 8 countries in 13.5 months, beating the enrollment goal by 4.5 months!
The US team enrolled approximately 47% of patients at 8 sites and the EU team enrolled approximately 52% of the patients at 16 sites.
The first patent was recently completed in Europe! This represents an important milestone towards a successful study completion.