Article | May 19, 2015

Late-Stage Biostatistics Submission Services: Bridging The Gap In NDA Submissions

Source: Rho
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RobWoolson

By Rob Woolson, Chief Strategist Biostatistics and Data Standards for Regulatory Submissions, Rho

Many 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.