Why use A4P to manage outsourced bioanalysis
It may seem counter-intuitive or even wasteful to further outsource an already outsourced activity. After all isn’t outsourcing the way to completely remove your resource and expertise problem by engaging and pay for an end to end service. So why indeed appear to pay twice for what looks like the same thing?
Sponsors outsourcing drug development activities are obliged by regulatory authorities to demonstrate oversight of those activities. The sponsor is judged to be solely responsible for the work and whilst outsourced providers have accountability to the sponsor, this has to be demonstrated, most often by documents and records.
Often, it takes a lot more resource than sponsors first or subsequently realise to actually manage and deliver this oversight. Recent analysis off this area suggests only 1 in 5 sponsors believe they actually completely fund and resources their needs. In our experience, gathered over many years and numerous programs that failing will often lead to issues that are, at best costly to fix at a later date or simply just not possible. This can be especially true in those first critical steps in a regulatory development programme. So, avoiding that consequence can and does protect investments.
Equally, importantly if you are outsourcing bioanalysis, it is critical to ensure that the oversight is performed by people that have expertise and experience in this area.
Using our extensive experience A4P provide the resource, processes and expertise to deliver demonstrable oversight and effective management of outsourced bioanalysis.