10 Considerations of Offshore Locations to Support Clinical Trials

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. 

1. Where is the appropriate talent located that is required for the activities under review?
2. How can off-shore resources be utilized?  In-house development or outsourcing strategy?
3. Can the lower FTE costs in lower cost regions be maintained in the mid-term?
4. What is the total cost of oversight of any activities being undertaken in other regions?  How can this be measured?
5. If all activities are moved off-shore, how will on-site / local talent be developed and will company knowledge become diminished?  What will the future look like for these roles in US and Europe?
6. Although off-shore rates may be lower at the moment, do productivity rates match those on-site or in high cost locations with longer experience levels?
7. Are there certain activities that would be better to keep on-site or local and others than can more easily be moved to off-shore locations?
8. How flexible are the various options given the peaks and troughs of clinical development?
9. Can contractors play a role and is this an efficient option?
10. How would this impact the current company structure or outsourcing strategy?

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?