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Services
quote_vsmall.pngAs a highly experienced medical writer, I am often asked to work on unusual documents. If you have a document or project that is not covered below, please don’t hesitate to contact me to discuss it in further detail, and I may be able to help. quote_close_vsmall.png

Document Preparation

  • clinical study reports (ICH standard; Phases I, II and III)
  • protocols (for Phases I, II and III, and QT interval for ICH E14)
  • investigator brochures
  • informed consent documents
  • regulatory submission documents (CTD modules)
  • standard operating procedures
  • manuscripts and abstracts
  • training materials
  • case report forms

Editing and Quality Control

In addition to medical writing, I offer detailed editing and QC checking services.

Training Services

I have trained a number of different individuals, including junior medical writers and clinical research associates. Please contact me if you would like to discuss training in more detail.

Standard Operating Procedures, Style Guides and Document Templates

I can easily work to a client’s own Standard Operating Procedure and style guide. In addition, I am very comfortable working with document templates that are provided by clients or I can provide my own templates if you do not have an in-house template. I am an expert user of Word, and I can use macros.

Publishing

Some clients also require a publishing service, and I have the capability to provide complete published documents, fully bookmarked, as pdf files.