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when. This ensures that data integrity and version control are properly maintained. |
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In the late 1980s, the FDA initiative to promote Computer Aided New Drug Applications (CANDAs), suggested strong movement towards integrated systems with a final electronic deliverable. For a variety of reasons, progress has not been as fast as originally hoped. Today, the compilation and submission of clinical trial data alone is often termed a CANDA. Without integrated systems, compiling an electronic submission can be as manually intensive as the paper process. |
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Beyond these developments in document management and groupware, use of integrated systems has been limited, particularly within project management. Project management in drug development has been treated, primarily, as a separate administrative function with little autonomy or authority over financial, personnel or time-line issues. This function is generally focused on dealing with project planning and tracking. The IT which supports it is another example of a stand-alone system. In reality, it is little more than an additional personal productivity tool on the desktop, sitting next to the word processor or graphics package. In some organizations where the requirement for more integrated project management has been identified, more sophisticated and specialized (and significantly more expensive) packages have been used to provide vertical integration. These packages provide roll-up capabilities to integrate different project plans. This gives an overall picture of the organization's drug development pipeline. Unfortunately, these systems are not renowned for their user-friendliness or level of functionality compared with the more generic, mass-market, stand-alone project management tools. The more sophisticated systems often provide project tracking information for senior management but are of little use to the project manager. This often means that the project manager maintains information on two systems, leading to significant inaccuracies and data integrity issues. |
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Compounding this problem further, the exchange and collection of information is frequently carried out manually. Many organizations use isolated project management teams to collect and enter the data. The quality of information supplied to these teams is generally poor and the processes of data collection, input, and production can be lengthy. Consequently, the collated information is often out-of-date, inaccurate, and cannot be relied upon for critical management decisions, and this has a crucial impact on project management. Any inaccuracies are further compounded when roll-up is used to provide a broader R&D picture. |
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