The goal of regulatory compliance often hinders drug developers from creating a data management strategy that would provide them a financial return on compliance IT investment. But to realize such a return, decision-makers must first recognize the opportunity.
So says James Hendry, EU regulatory process specialist for submissions software maker ISI, in Scientist Live. Reporting to regulators need not be done "at the expense of enhancing the interrogation of valuable data for commercial advantage," he writes.
Drugmakers are beginning to catch on, he says, citing a 2009 survey that finds the biggest companies making changes to their submission management systems with an eye toward predictive planning. But the majority of survey respondents report gaps in their systems; more than 70 percent say they use manual tracking and spreadsheets to generate reports.
A common pitfall among drug developers, says Hendry, is failing to maintain tracking vigilance beyond the drug application or marketing authorization milestone. These should be the first steps, with post-approval process tracking another key component.
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