INC Research/inVentiv Health was initially contracted to prepare approximately 210 serious adverse event narratives for a leading global biopharmaceutical company. During this initial engagement the client received a demand by the FDA on its NDA submission and the need for additional patient narratives for serious adverse events (AEs), discontinuations, and AEs of special interest. Due to this critical, unanticipated request our scope of work with this client was expanded to provide approximately 1,500 patient narratives. The project scope included both new narratives and updates to existing narratives. The entire narrative project needed to be completed within 3 months.
To accommodate the work and meet the aggressive timelines involved, INC Research/inVentiv Health quickly expanded its original team from 3 to 6 medical writers and from 1 to 2 quality control (QC) reviewers. We leveraged our years of experience in building efficient teams to ensure consistency in the writing style and processes required for the project.