Of the many challenges facing the biopharmaceutical industry, the critical need for greater operational efficiency in clinical drug development is paramount. With flat and even declining productivity, rising research and development costs; more complex preapproval 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. While progress has been made in addressing these challenges, companies are increasingly turning to clinical trial management systems to improve trial efficiencies, cut trial costs, and enhance the productivity of trial participants.