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2012年01月05日

‘Process, Risk, and Outsourcing’

With two big deadlines approaching, I should currently be up to my neck in a pilot project and literature review for my doctoral programme. At the moment, I am only up to my knees in it, which means that my New Year will be busy! Anyway, as I waded through the transcript of a very recent interview with a Japanese repatriate, I was struck once again by an excellent example of cultural attitudes to a) risk, and b) outsourcing. In the interview, the repatriate (who works for a pharmaceutical company) said, “When I worked overseas, I learned a lot about the differences between Japanese clinical organisations and Western ones. In a nutshell, Japanese clinical development means working in detail and in a meticulous way with a CRO [clinical research organization]. On the other hand, in the West, the main responsibility is to manage the CRO, not to work closely on operations. It is about vendor management.”

The repatriate went on to say, “In the Western organisation, we had a plan about how to use the clinical organisation, its roles and responsibility. The final deliverable from the CRO was the final report, so we reviewed the final report and data. We double-checked case reports. Then we picked up ten percent, fifteen percent, to see if there was any problem, and then if it was OK, well, it was OK. Yes. However, once we made our submission to a regulatory agency like the FDA [Food and Drug Administration], the regulatory agency checked as well and then if they pointed out an inconsistency in the data, that was our responsibility as the study sponsor. Western people, US people, they seem to feel that people will make mistakes, it’s a human thing, that’s the basic concept, so it’s OK, but in a Japanese clinical organisation, there’s almost always very careful monitoring of consistency between raw data and reports by the sponsor. It’s not just the CRO.”

This difference can certainly be explained in terms of the process orientation of many Japanese organisations, as opposed to the action orientation of many of their American counterparts. In addition, appetite for risk differs between countries due to cultural, historical, and structural issues. America is more entrepreneurial than Europe, for instance. Japanese people and their companies are famously reluctant to embrace risk. This is perhaps because the Japanese world view tends to be that there is enough uncertainty in the world anyway (which requires rinki ouhen) without actively encouraging it. In comparison with that Polychronic attitude, Monochronic people in more risk-friendly cultures such as the USA have more confidence in their contingency plans, and perhaps most crucially, in the idea of a second chance.

In an individualistic society that preaches forgiveness, that is not surprising. If you make a mistake, you apologise sincerely and then receive absolution. A second chance is harder to come by in a Polychronic culture in which people know one another’s business. Failure almost certainly seems more threatening collectivist cultures. It is no surprise that venture capital is more common in the United States than in Japan (http://www.economist.com/node/13216037) or Singapore or the UAE. There are complex pricing models to assess risk, such as the Capital Asset Pricing Model. In the USA, venture capitalists are often said to be sympathetic to entrepreneurs who have failed in past, as they have (presumably) learned from their past mistakes and so are more likely to be successful this time. On the other hand, the governments of Singapore and the UAE have famous investment funds - that is more collectivist than individualist.

Meanwhile, the High Context, Ameba (Polychronic) business approaches that are common in Japan often do not work well with outsourcing. One reason is that High Context people may have trouble specifying in an explicit manner what it is that they need from their business partner, whereas Low Context and Tetrispeople are more comfortable negotiating an explicit scope of work and then auditing the result rather than the process. Furthermore, Ameba tendencies will mean that people involve themselves in matters that are beyond the strict scope of their explicit responsibility, such as data consistency.

This reminds me of a story told to me by a manager in a Singaporean CRO. The parent company is North American. When an Ameba client asked her to go beyond the boundaries of the scope of work because of an unexpected development in the clinical trial, her first instinct was to comply. When she mentioned it to her North American, Tetris supervisor, however, she was told to stick to the scope of work, or to negotiate a new one and charge more money. She decided that it was in the best interests of her company to do as the client requested and ignore her supervisor. In her next performance review after the project had finished, her supervisor congratulated her and asked her how she had managed to both complete the project so smoothly and get such a high evaluation from the client. She told me that her response was necessarily very vague - she couldn’t talk to her North American supervisor about the things she had done outside the scope of work!

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