To centralise or not to centralise. That is not only the question now, but has been for a very long time. There was a trend for a while among some large pharma companies to centralise all product data. It seemed to make a lot of sense: data would all be in one place and the problems companies encountered with their affiliate groups doing their own thing could be alleviated.
There is a problem with this model. Pharma companies are geared up to deal with the EU and U.S since that’s where traditionally headquarters were based and people’s expertise lies. But the emphasis on emerging markets has placed a real crunch on the need for Russian expertise, Middle East expertise, Pacific region, Africa, and so forth. With the detail of information health authorities are demanding, insight into these markets is important. And how can someone sitting in an office in the UK be an expert in, for example, Saudi Arabia? As a result, some companies that had moved to a more centralised model are reverting to a regional model.
But, of course, legislation such as the EVMPD throws a spanner in the works because companies need to be able to easily access product data. There is a tendency to downplay the significance of this. Someone at a senior level in the company will decree that everybody must follow a certain strategy and use a particular system. But that doesn’t necessarily make it happen at a regional level. The powers that be do need to understand the strains the affiliates are under, particularly those in the smaller regional offices. These personnel can often have two different reporting lines, two different focuses. They often report into a country head, whose focus is commercial, not R&D, and this splits the affiliates’ levels of responsibility and adds to their workload. As a result, these affiliates might not do the level of data collection central office needs. That is a big problem when it comes to inputting data into central systems.
To find more information please click here: CSC: A Central Dilemma – the Complexities of Managing Data - By Gillian King
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