Data Management

Clinical Trial Management: Enabling Operational Efficiency

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Executive Summary

The way the biopharmaceutical industry conducts clinical trials is undergoing a remarkable transformation. Coupled with this much needed evolution are new challenges specific to the increasing role that information technology will play to enable the new clinical development landscape. Of the many challenges facing the biopharmaceutical industry today, the critical need for greater operational efficiency in clinical drug development is paramount. With flat and even declining productivity, rising Research and Development (R&D) costs, more complex pre-approval trials and large post-approval studies driven by the shift toward biological agents, and increasing regulatory demands, it is essential that clinical trials are managed more effectively and efficiently.

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