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IV. Project Implementation |
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The technical functions that CROs carry out, such as project management, clinical monitoring, drug safety reporting, biostatistics, medical writing, etc., are typical of the pharmaceutical development process and are well known by professionals in the field. These activities will not be addressed here, but it is of utmost importance to recognize that all required functions and activities must be appropriately integrated into the sponsor-CRO project team. |
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Keeping in mind the keys to success that are summarized above, it is essential that the CRO and sponsor work together as a team that has common goals. This requires that the team clearly understands all of the project's specifications and expectations, and in some extreme instances, it might be necessary to help the pharmaceutical sponsor identify specific expectations. Virtually all clients differ to some extent, some requiring only process support while others look to the CRO for leadership and guidance. |
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Each member of the team must not only be competent to carry out specific tasks, but must also buy into the concept of teamwork. Importantly, the project leaders, one generally at the CRO and a counterpart in the client company, must coordinate the activities of the entire team and must facilitate communication among team members. Fortunately, the advent of a myriad of electronic communication tools for video, voice, text, and data have dramatically facilitated this vital exchange of information. The technology per se, however, will not ensure communication success; rather a commitment to utilize these tools is key. |
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As study data are often key deliverables in a CRO-sponsor relationship, and since data management technology is often being enhanced through the cooperation of these two parties, a review of key issues in data management follows. |
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A. Data Retrieval and Review |
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The interface between clinical monitoring and data management is blurred and overlapping rather than a distinct line. Most studies use paper to capture original or source data. The appropriate data are then transferred manually to paper case-report forms. Study monitors visit clinical sites to verify, among other things, that source data were accurately transcribed from one document to another. Currently, the primary transfer point between clinical monitoring and data management is the delivery by or through monitoring of paper-based case-report forms. However, advances in data capture and transfer technology are changing the ways clinical monitoring and data management are being performed, and CROs are playing a major role in the change. In some instances CROs are taking the lead in developing new approaches while in others, par- |
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