Case Study 3
Diabetes Trial
A US-based, rapidly developing bio-pharmaceutical company needed to conduct a study with about 80 Type 1 and Type 2 diabetes patients. The company was under an extreme pressure to enroll these 80 subjects in less than 60 days in order to keep to the internal NDA submission timelines. Due to the study design, the number of countries and sites needed to be kept to the minimum.
ClinStar successfully obtained all necessary regulatory approvals and import/export licenses, and conducted the trial within the promised timelines. Despite the logistical difficulties due to prolonged Russian national holidays in the beginning of the year, ClinStar facilitated enrollment of 76 patients at only 2 sites in Russia; 74 patients were enrolled at one site and 2 patients at the second site.
Timeline:
- Day 1
- ClinStar receives the first request from Sponsor.
- Day 16
- ClinStar receives documents from Sponsor.
- Day 19
- ClinStar and Sponsor submit proposal to FEC and Pharmacological Committee.
- Day 64
- ClinStar and Sponsor receive approval from Pharmacolocial Committee.
- Day 70
- ClinStar and Sponsor receive approval from FEC.
- Day 79
- ClinStar and Sponsor receive final approval from Ministry of Health.
- Day 85
- ClinStar and Sponsor obtain the required import and export licenses.
- Day 145
- ClinStar completes LPLV and sends all CRF pages to database and samples to lab.
- Day 156
- Database locked.
At the end of the study, we received the following e-mail from the client:
“…I wanted to thank you and the entire [Study] team for a real excellent job well done. I think I'm not exaggerating when I say, we have accomplished the impossible. By far, the fastest and cleanest study in [Sponsor] history. Everyone at [Sponsor] was truly amazed we were able to complete the study and how fast and well we did it…” - Clinical Trial Manager
