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Assignment Questions

The clinical trial administrators

Application: Outsourcing and Associated Contracts

You learned in a previous course that outsourcing is a growing trend in the administration of clinical trials. This week you will examine a hypothetical situation in which a new biotech firm outsources its trial to another firm in Central Africa. The clinical trialadministrators will be faced with a number of contractual issues.

To prepare for this Application Assignment, consider the following scenario:

You and a colleague, who own the patent rights to a compound that is potentially efficacious in the treatment of Alzheimer?s disease, have decided to form a new pharmaceutical company. Your colleague has the rights to the patent on the potential product, and you and your colleagues have the skills to do the research.

To complete this assignment, write a 1- to 2-page paper about the contracts associated with outsourcing this trial. Be sure to include your response to the following questions in your paper.

What services will you need to continue development?
What kinds of organizations will you need to contract with in order to succeed in your developmental activities?
Submit your Application Assignment to the Dropbox by Day 6.

Your written assignments must follow APA guidelines. Be sure to support your work with specific citations from this week?s Learning Resources and additional scholarly sources as appropriate. Refer to the Pocket Guide to APA Style to ensure your in-text citations and reference list are correct.

Save your Application as a “.doc” or “.rtf” file with the filename “APP4+last name+your first initial.” For example, Sally Ride?s assignment filename would be “APP4RideS”. Use the Submit an Assignment link, choose the Week 4: Application basket, and then add your Application as an attachment.

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