
20 Seagoe Industrial Estate
Craigavon BT63 5QD
United Kingdom
+44 (0) 28 3833 2200
http://www.almacgroup.com
Validation and execution of biomarker assay using qPCR
Date: November 28, 2014
Service Description
Almac was contracted to transfer in an internally-developed qPCR assay, validate that assay on FFPE samples we provided, then execute that assay under CAP/CLIA guidelines on novel samples from a clinical trial.
What Went Well
Almac provided rapid turnaround on a quote and study design, and managed the project to the quoted budget. Their scientists worked with ours to confirm that the assay was validated to our specifications, and provided thorough documentation of their work. Their sample handling was flawless, and they even identified a discrepancy in our logistics and suggested a workaround which didn't compromise the data from a study with a limited number of samples. Their data quality was robust.
What Could Be Improved
Although the service was generally excellent, there were a couple of delays in their execution. Having stated that, they were forthcoming about the reasons for those delays (technical issues, partly within and partly beyond their control), and the delays were relatively short (<1 week each). Otherwise, there were no noted areas for improvement.
Lessons Learned from the Experience
Almac was a pleasure to work with. One of our goals for the project was to determine the feasibility of engaging them for a larger study, and we were sufficiently impressed with their execution that we have since worked with them on multiple larger projects. The logistical issue they identified and for which they proposed a solution was very helpful to the success of the project, and while the solution was relatively straightforward, noticing the problem in the first place was not trivial.