In April 2020, a leading biotechnology company required the authoring of 3,000 narratives in approximately four months across four studies for its BLA. Historically, their statistical programming group had been able to generate the patient index and programmed template output required for drafting the narratives, which the writing vendor’s team then used to complete full drafting. This took weeks, even upwards of a month to produce. From the start, they felt the timeline was working against them and nearly impossible to meet.
The fact you could produce the first drafts so quickly was a key benefit for our timeline. And the fact that the QC review was built in was an additional factor that contributed significantly to meeting our timeline goal