Crohn's Disease Case Study
A Korean biopharmaceutical company urgently needed biospecimen from subjects with Crohn's Disease to complete data collection for a rapidly approaching regulatory filing deadline. This study was particularly challenging as it started over the end-of-year holidays, a notoriously difficult time for subject recruitment, and was compunded by the fact that as few as 1 to 16 out of every 100,000 people in the US have been diagnosed with Crohn's Disease.
The research lab initially needed a single draw of 60 million PBMCs from each of the 30 Crohn's patients, which equates to approximately 75 ml of blood. Furthermore, the lab would go on to request an additional 2-3 redraws of the same volume from each subject with minimal notice, thereby requiring expedited IRB changes.
Sanguine was able to offer the shortest lead-time among all potential vendors, thereby winning the bid for the project. Sanguine developed an online advertising patient recruitment strategy that successfully recruited all 30 donors in just 1 week! Impressed with the speed of delivery and quality of the cells from this cohort, the lab immediately requested redraws of the same volume from each subject, giving Sanguine only 1 week's notice, and requiring Sanguine to file extensions to their approved IRB protocol to accommodate this volume. After receiving all specimens from the second round of collections in 2 weeks, the client again requested an additional redraw. Sanguine quickly filed another extension and completed the collections in another 2 weeks!
Ultimately, 2-3 redraws from 30 subjects were completed in 6 short weeks. In addition to delivering on such a short timeline, there were two patients that were unavailable for the short notice redraws due to relocation or travel; however, thanks to Sanguine's nationwide mobile phlebotomy network these subjects were able to complete the longitudinal collections in their new locations, ensuring that no new subjects would need to be enrolled. The entire collection was completed in time for the company to analyze the data and meet the regulatory filing deadlines thanks to the efficiency of Sanguine's mobile phlebotomy network.
Developed and successfully recruited 30 qualified Crohn's subjects
First draws completed!
First round of redraws requested
First round of redraws completed!
Second round of redraws requested
Second round of redraws completed!
Multiple IRB amendments for high volume collection
Two subject relocations mid-collection yet maintained enrollment
On time for regulatory filing requiring 90 draws in 40 days