YOUR GOAL: Get new drugs to market faster

Jun 17th, 2015
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Alfred University
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In the competitive race to market, pharmaceutical companies are continually looking for better ways to reduce the time between end-of-study and FDA submission. Accomplishing this requires that you address the issues that cause delays in collecting,

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SUsing SAS, a top-10 pharmaceutical companyhas reduced a 45-day processingand reporting cycle to two days.Challenges Reduced time on patent. Costlydelays reduce time on patentbefore generic production begins. Changing regulatory demands.Compliance with current guidelinesand CDISC standards (ODM, SDTM)is difficult. Data discrepancies. Inconsistenciesthat need to be reconciled withsource data cause time delays. Multiple data formats andsources. Study data submitted indifferent formats from multiple globalclinical sites is hard to integrate andstandardize. Unpredictable end-of-studydemands. Last-minute issues andunforeseen problems necessitate thesupport of unscheduled datamanagement resources.YOUR GOAL: Get new drugs to market fasterIn the competitive race to market, pharmaceutical companies are continually lookingfor better ways to reduce the time between end-of-study and FDA submission.Accomplishing this requires that you address the issues that cause delays in collecting,verifying and auditing the accuracy of your data and in converting that datainto the right format for statistical analysis.Combining disparate data from multiple sources and systems can result in errors,discrepancies and a backlog of queries that require unplanned time and resourcesto resolve. In addition, as pharmas and CROs manage increasing amounts of clinicalinformation, ensuring data integrity and complying with industry standards are more

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