Convincing regulators to approve drugs has never been easy, with billions of dollars spent each year to generate the clinical evidence required to clear the multiple safety and effectiveness hurdles. Many people have hailed the era of big data as a turning point for pharma, with the latest technology allowing for an increasingly granular and detailed readout of a drug’s performance in clinical trials. But with great insights comes great quantities of data and managing the vast amount of information generated by a study can be difficult.
In a recent interview with Pharmaphorum, Cytel's Executive Director of Data Management Paul Fardy discussed the importance of establishing a clinical data strategy, an element of planning that is all too frequently decided too late in development - putting the investment in the trial at risk.
In the article, Paul explained the changes that needed to be made to the way sponsors think about their clinical data, by defining what data is being collected and the kind of standards that must be applied as early as possible.
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