Medical Writing Services

Comprehensive solutions for your regulatory and clinical documentation needs

End-to-End Medical Writing Support

From early-phase clinical development through regulatory submission and post-marketing, ESW Communications provides expert medical writing services that meet the highest quality standards. Our experienced team delivers scientifically rigorous documents that comply with ICH guidelines and regional regulatory requirements.

Clinical Study Reports (CSRs)

ICH E3-compliant CSRs for Phase I through Phase IV studies. Complete report development from shell to final.

  • Full CSR Development
  • Abbreviated CSRs
  • CSR Amendments
  • Legacy Reports
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Regulatory Submissions

End-to-end support for global regulatory submissions including CTD summaries and briefing documents.

  • NDA / BLA (FDA)
  • MAA (EMA)
  • CTD Module 2
  • Briefing Documents
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Patient Narratives

Comprehensive patient narratives that clearly present individual patient safety data.

  • SAE Narratives
  • Death Narratives
  • Discontinuation Narratives
  • Protocol Deviations
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Integrated Summaries (ISS/ISE)

Comprehensive integrated summaries of safety and efficacy that synthesize data across your clinical program.

  • ISS Development
  • ISE Development
  • Cross-Study Analyses
  • Pooled Data Presentations
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Scientific Publications

High-quality manuscripts, abstracts, and posters for your publication strategy.

  • Journal Manuscripts
  • Congress Materials
  • Review Articles
  • White Papers
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Clinical Trial Documents

Essential documents for clinical trial conduct, from protocols to investigator brochures.

  • Protocols & Amendments
  • Investigator Brochures
  • Informed Consent Forms
  • Development Plans
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Our Process

1. Discovery

Understanding your requirements, timelines, and strategic goals

2. Planning

Developing document shells, outlines, and writing plans

3. Development

Writing, internal review, and iterative refinement

4. Delivery

Final QC, client review, and on-time delivery

Ready to Get Started?

Contact us to discuss your medical writing needs and how we can support your next project.

Contact Us Today