Case Studies
CRU-GLOBAL sites are the worldwide top enroller in many multicentric studies in many different therapeutic areas and clinical phases. High and quick recruitment is supported by:
- CRU's dedicated, full time staff
- Active continuous pre-screening activities
- Big patients and healthy volunteer' databases
- Own patient pool and continuous flow from CRU's public medical services
- Well developed and maintained GP and specialist referal network
- Proper use of advertisement opportunities by CRU and/or via external vendors
Phase I Cases
Phase I study with moderate hepatic impairment patients and matching healthy volunteers.
Multinational study with 5 different sites. Target patient number in first part 10 patients and 10 volunteers. CRU Phase I Unit in Hungary screened all the 20 patients within 4 days, before any other sites received the regulatory approval and/or green light for study start. The study was completed within 3 weeks (19 Days from Site Initiation visit up to the last patient last visit) 1 months earlier than Sponsor’s best scenario!
Phase II Cases
Phase II study with NASH indication.
Multinational, multicentric RCT with 17 sites worldwide. Study is complicated due to special MRI requirements. One unique CRU site enrolled over 65% of all patients worldwide and with this high performance the study was completed many months earlier then originally planned. The study was audited. Neither major nor critical findings.
Phase III Cases
Phase III cardiovascular outcome study.
Enrolling over 22,500 patients in 800 clinical centers worldwide. CRU site was the worldwide best enroller with 177 randomized patients. The sponsor was able to submit the study results to the FDA on time and got market authorization just before all other competitors. The site was audited by the sponsor: neither critical nor major findings, and also inspected by FDA after study completion with NAI result.