Project Management  »  Management Approach April 24, 2018

   Our Study Management Approach

The diagram below typifies the study management approach which has proven so successful for American Ag for the past 22 years.

  • Most typically the sponsor company will serve as the study monitor. The overall function here is one of truly monitoring the study and providing planning and management direction and communication with American Ag. This may be one person or it may be several people depending upon the volume of work which is contracted to American Ag and the study monitor's experience with certain chemistries, etc. This does not preclude the sponsor from having an analytical chemist work with American Ag and the analytical laboratory on certain chemistry issues. Nor does it preclude quality assurance personnel from working directly with American Ag and providing QA inspections of American Ag and the various field, processing, and analytical contractors.

  • Most typically American Ag functions as the Study Director. The primary function here is one of direct interface with the sponsor for the planning and management of the study and communication related to the study as well as the true GLP function of the Study Director. This may be one or more persons at American Ag, again, depending upon the volume of work and nature of the individual studies. It may well also include one or more project managers internal to American Ag which insures that each study is given adequate attention.

    Reporting separately from the Study Director but certainly inherent in the structure is an internal Quality Assurance Unit at American Ag which plans, manages, coordinates and conducts quality assurance inspections of the various contractors as well as the internal American Ag operations.

  • The field contractors are quality, GLP compliant, private field researchers located throughout the United States, Canada and Europe. For Latin America and Asia, we identify quality, cooperative biologists and American Ag provides on-site management support and Quality Assurance. We will not contract to one or two large organizations which profess to be able to provide everything. Rather, we will select from among our large base of field research contractors to insure that we have selected the best field researcher for the particular geography and crop in question.

  • As appropriate, large bulk samples of crop commodities will be shipped from field contractors to various processing laboratories for processing into eatable food fractions. American Ag has extensive experience with all the major processing laboratories. Each of these is GLP compliant and, depending upon the crop commodities, can provide the required processed food fractions and necessary report of their activities.

  • American Ag also has extensive experience with all the major analytical laboratories in the US and Europe. These will be selected in concert with the sponsor based on a favorable working experience, available timeline to conduct the study, experience with the various analytical methods and chemistries, and cost.

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