There has been increased interest across the life sciences industry to use lower cost regions such as India, China, Eastern Europe, South America and South Africa to support functions including clinical data management, statistical programming, biostatistics, pharmacovigilance and medical writing within clinical development and safety monitoring areas.
As such, I have seen lots of discussion occurring within companies and at congresses around what tasks should be moved off-shore and which should remain either in-house or outsourced locally. Undoubtedly, there is a benefit to using optimal locations to support these functions given the growing focus on driving drug development cost savings, but the question is usually around what the best structure should look like.
In this first blog on the subject, I have provided a high level list of the items that I often see being discussed. I am sure there are many others. Whilst there are many different approaches, the following items usually come up in the development of a company specific solution in one form or another.
Quality is a common strand across all of these considerations. It is ultimately the overall cost to enable high quality outcomes, that will determine whether a given scenario works within a particular company. Determining the true cost is often the challenge as a review of just FTE hourly rates can be misleading. In future blogs, I will comment in more detail around each of these points but I would be interested in views and comments from others regarding the use of a multi-region approach and also thoughts around the importance of on-site / local expertise. What does the future hold? How do you see it?
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