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earlier. An early launch will win you more patent protection and get in front of more of your competitors. The second program will be no later than if you had run them at the same time. |
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Admittedly the clinical project manager rarely has the freedom to make such decisions and, instead, has to manage conflicting resource demands by developing his/her own rules for deciding priorities. The answer to give when a new project is imposed by top management is not No, but Yesbut we can't start until . |
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G.
Progress InformationCan We Believe It? |
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If you have read this far, you will see that project management software can be far more than just a planning tool. You can be updating your plans to give you ongoing control of your clinical trials (although it has been said that software does not manage projects, only people do). To do this, reliable information on study progress is needed, and the word reliable is vital. The most commonly-used measure is patient recruitment, but this is only of value if it is clearly defined. Do we mean number of patients screened, number randomized, number valid for efficacy analysis, or any of a host of other definitions? Unless these definitions are clear from the outset, progress will be impossible to control properly. The best way to define progress points is by using items which can be proven ( deliverables)Is there physical evidence of the clean case report forms (CRFs) in-house, for example? Unproven information may still be useful for giving early warning of problems but should not be relied upon for reporting progress to senior management. |
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H.
Senior Management Revisited |
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Reports to management tend to consume huge amounts of effort. One country affiliate is required to send a clinical research report to its overseas head office, and this report runs to at least 80 pages every month. Much of the information is repeated from previous months, and all the multitude of details cannot be read by all the recipientsthey would never have the time. The key to effective reporting lies with the project manager, who must get agreement on what information is necessary and when. Much the same applies to progress meetings, which are usually used to report progress. If concise, easily understood reports have already been issued, why repeat the exercise during the meeting? It is far better to use the time for decisions based on information already available, so here is another role for the project manager, catalyzing effective meetings. |
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