Drug Information Journal - March 2009 - (Page 168) 168 MEDICAL INFORMATION Hyveled, Karpur, Nakskov FIGURE 8 Continual data evaluation and correction reduced the overall time from symptoms of intracerebral hemorrhage to dosing with NovoSeven. 100 80 60 42 40 20 0 Before Corrective Action Taken 74 95 Symptoms of ICH to admission Admission to CT scan CT scan to dose Admission to dose 66 85 Minutes 53 53 32 After Corrective Action Taken closely with international trial managers, CRAs, and external vendors, and is responsible for keeping track of every piece of information and also for disseminating the relevant information to the right people at the right time. The information logistics manager had a range of roles including helping to ensure that CRA information was processed on time, acting as a complaint center for possible delays and quality issues, and warning international trial managers or senior managers of potential issues so that corrective action could be taken. For CIOMS reports approximately 10 iterations of the tracker were created, and a new process for scanning and posting information to the study website was created for effective CRA site management. As expected for a critical care study, multiple departments provided patient care at each trial site (eg, local laboratory, radiology, emergency department), creating additional management requirements. Hence, protocol and study awareness was needed across all departments involved, and in some hospitals separate contracts were required for each department affected. Overall, there are multiple benefits of this new approach to clinical operations. There is limited data delay, and continual data flow analysis provides multiple opportunities to optimize the process flow. The time from study end to results (last patient last visit to database release) was shown to be reduced by 50–75% (Figure 9). Indeed, the value curves for standard clinical trials versus the trials in an unpredictable setting are considerably different (Figure 10), clearly illustrating the need for implementation of new methods. Thus far, Novo Nordisk NovoSeven Key Projects have managed to establish an optimal environment for exchange of knowledge (knowledge leadership) and implementation of continuously evaluated actions to produce desired results. P E R S P E C T I V E F O R O R G A N I Z AT I O N S Information management in clinical development operations is generally based on predefined processes that assume that a series of events will take place. This, however, presupposes a very high degree of predictability. Standard operational procedures are founded upon this nonchange approach and expectations. Problems arise when the organization is placed under pressure both from an unexpected increase in the amount of data generated and an increase in the range of possibilities in the information. In a linear and deterministic system (eg, production economics), the outcome of a given input is expected and a limited amount of fluctuation is the goal in itself. In knowledge economics, there is substantial variation as a natural consequence of the proliferation of data and
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