|
|
|
|
|
|
|
Fig. 11
Key relationship: the solid ellipse shows the laboratory in a central position
interfacing with several teams, both at headquarters and with Pharma personnel. |
|
|
|
|
|
|
|
|
Advisors and CRAs, the difference being reflected in the number of individuals being employed. Most of the major Pharmas also have a Quality Assurance Unit. Good working relationships with these individuals are essential in order for the laboratory to effectively support pan-European clinical trials. As illustrated in Figure 12, all regions of Europe are covered by these Pharma offices with the major Pharmas being located in France, Germany, Spain, Holland, Belgium, Scandinavia, Italy, and the U.K. |
|
|
|
|
|
|
|
|
The Pharma Medical Advisors directly resolve most issues raised by the investigator or they function as a local intermediary for the laboratory to provide the appropriate information. There are no language difficulties to hinder communication and the Medical Advisors are familiar with the local customs and working practices. It is the local Pharma CRAs who are responsible for the conduct and monitoring of clinical trials in Europe. At the start of a trial the laboratory provides the CRA with an investigator brochure, customized |
|
|
|
|
|
