Clinical Study Report Medical Writing

I need an experienced medical writer who can take a completed Phase II data package and craft a full Clinical Study Report (CSR) that meets current ICH-E3 and GCP expectations. All statistical tables, figures, and listings are already generated; I need you to weave them into a clear, scientifically sound narrative, structure the document correctly, and ensure terminology is consistent throughout.

Scope for this first milestone
• Draft and revise the complete CSR, including synopsis, efficacy and safety results, and appendices.
• Align content with the supplied protocol, SAP, and all raw outputs.
• Reference current regulatory guidance so that the document is submission-ready for both FDA and EMA.

Looking ahead
After the CSR is finalized, I will move on to the Investigator’s Brochure. For that document I will only require a concise description of possible risks and side effects, kept at a high-level overview rather than an exhaustive data dump.

What I’ll provide
• Final protocol, SAP, annotated CRF, and all TFLs in Word/Excel/PDF.
• Previous agency correspondence that clarifies preferred phrasing for key endpoints.
• Style guide and company templates.

What I expect from you
• Proven track record writing CSRs for late-phase trials.
• Ability to cite and cross-reference source documents accurately.
• Fluency in AMA or similar style and strong command of plain-language summaries for lay readership.
• Turnaround of the initial draft within three weeks, with two revision cycles to follow.

If this fits your expertise, please outline your relevant CSR experience and confirm you can start immediately.