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E. Some Examples of CRO Studies |
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How do you know which opportunities are good ones for contracting in a CRO? Here are some examples of instances in which contracting in offers important advantages at different points in the drug development process. |
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New Therapeutic Class: Phase I and/or Early Phase II. Contracting in a CRO with experience in a new therapeutic class speeds up development and brings the sponsor up on the learning curve quickly with a minimum investment. |
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Phase IIIB. By having a CRO do the study while the sponsor completes Phases III and regulatory submission, two key activities happen simultaneously, saving valuable time. In some companies, it would be extremely hard to resource both at once. |
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Large Global Phase III. The CRO works with a small team from the sponsor to plan and implement studies while the rest of the sponsor's resources accelerate completion of Phase II and development of output tables and final report outlines for global submissions. |
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Global Product Development via Virtual Corporation. A small team from the sponsor works with two major CROs to pursue an aggressive development timeline even when few in-house resources are available for the project. |
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V. Choosing to Contract in: Strategies for Successful CRO Selection |
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Although the characteristics of a close CRO-sponsor relationship would indicate that choosing to contract in may offer a relationship of potentially far more value, it is still a relatively new approach and, as such, may be considered with understandable trepidation about the risks of such close involvement with an outside source. |
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While contracting in may extend the capabilities of the sponsor far beyond what would ordinarily be possible, it remains of considerable importance to question how the sponsor can minimize the risks involved in the process. |
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This section is given over to specific steps the sponsor must take to ensure that the company enjoys the full advantages of contracting in and, at the same time, avoids the potential pitfalls. |
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The key concepts throughout the process of risk management are preparation, information, communication, clarity, and trust. The strategy associated with these concepts is threefold: define specifications clearly, choose the right CRO to meet them, and manage the relationship appropriately. |
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A. The Importance of Study Specifications |
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Study specifications identify the activities required to initiate, conduct, analyze, and report the results of a clinical study [8]. An accurate list of study |
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