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Late-Stage Biostatistics Submission Services: Bridging the Gap Between Technical/Data Standards & Regulatory/Medical Writing in NDA Submissions

number-magnetsMany CROs currently offer two categories of services to sponsor companies preparing for an NDA or marketing application submission. The first category contains technical data standards services. These services include converting existing clinical datasets to CDISC compliant formats and generating the datasets for the integrated summary of safety (ISS) and integrated summary of efficacy (ISE). The second category includes regulatory and medical writing services associated with the marketing application submission.

This article looks at the gap that exists between these two categories and a need for a broader range of biostatistics services needed to fill this gap.