Oncology Clinical Study Report

Accelerating submission timelines for a complex Phase III trial.

Regulatory Writing

The Challenge: Tight Timelines & Complex Data

A mid-sized biotech company completed a pivotal Phase III oncology trial and needed to submit the **Clinical Study Report (CSR)** to the FDA and EMA within an aggressive 12-week window to secure priority review.

The trial involved complex efficacy endpoints (PFS, OS) across multiple subgroups, and the statistical output was voluminous. The internal writing team was overwhelmed, risking a delay in submission.

Our Solution

MedicoWriter deployed a dedicated team comprising a Lead Medical Writer and a QC Specialist. We implemented a **parallel writing strategy**:

  • Shell Development: Drafted the report shell (methods, administrative sections) while the database was still locked.
  • In-Stream Review: Reviewed mock TFLs (Tables, Figures, Listings) early to identify data presentation issues before final run.
  • Rolling Review: Released sections for client review in batches rather than waiting for a full draft.

The Result

2 Weeks Early
0 Major Findings

The final CSR was delivered **2 weeks ahead of the deadline**, allowing the client extra time for their internal strategy meetings. The document passed the client's internal audit with zero major findings and was successfully included in the NDA submission.

"MedicoWriter's team didn't just write; they managed the timeline. Their ability to interpret complex oncology data saved us weeks of back-and-forth."
- Vice President, Clinical Operations