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regulatory position (product problems or recalls, FDA inspection results, etc.). |
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Information on all of these items is generally available from multiple sources. Some can be verified via direct interaction with the potential partners, and all will give you an overall sense of what the company is like, what their problems are, areas of concern, and possible areas of need. In all cases, as was mentioned previously, both parties in any long-term relationship need to feel that they are wanted, needed, trusted, and will benefit from the joint venture/alliance. A clear understanding of each other's needs, goals, and expectations will enhance the ability of both parties to realize how both can benefit from what kind of alliance. |
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One aspect often given inadequate attention is the issue of geographic and ethnic cultural differences. We are all aware or have heard about the cultural differences associated in dealing with Japanese companies, but do we really understand them, prepare for them, work through them, or do we simply acknowledge them and hope that we can work through them when the time comes? |
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The Japanese/Western difference is an obvious one, but there are just as many cultural differences between the U.S. and the U.K., or Germany, France, Switzerland, Sweden, Australia, or Canada. One of the most frequently overlooked issues is one of language. From a U.S. perspective, we often feel that if a company speaks English, we will have no problem in communicating. However, we often forget that we speak American English not British English or proper English which is taught in the local schools. Therefore, many problems are created unknowingly based on a perception that each understands the other when both have very different vocabularies and interpretations of the words used. |
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However, this phenomenon is not unique to companies of different countries. It has also been found between companies of the same country. For example, a discussion between two American companies regarding milestones about a clinical study start and stop could lead to problems. Unknowingly, both companies may have different definitions of these points. For example, to one company, study start means when a protocol is signed, to others, when clinical supplies are shipped or when the first patient enters the study, still in others, it is when the first patient actually takes drug. The same kind and number of differences can be seen with definitions of study stop. Stop can mean when the last patient finishes the study, when all supplies and CRFs are retrieved, when the data base is locked, or when a study report is signed. This is a simple example, which |
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