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Early Phase Medical Writing Specialists

Personalized Approach

Signa Medical Writing is a personal and dynamic medical communications company providing medical writing, electronic publishing, quality review, and consultation services for the pharmaceutical and healthcare industries. Our clients range from large international pharma companies and clinical research organizations to small start-ups bringing their first drug to market. Specializing in early phase clinical research, our skilled and experienced medical writers work closely with clients and sponsors to develop regulatory-compliant documents of the highest quality.

Knowledge and Expertise

  • Protocols and protocol development

  • Investigator brochures

  • Full or synoptic integrated clinical study reports (CSRs) and CSR addendum documents

  • Subject safety narratives

  • Electronic publishing

  • Quality review and document editing

  • Consulting

  • Training

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Experience and Professionalism

Signa Medical Writers have extensive knowledge of International Conference on Harmonisation (ICH) E3 guidelines and AMA style. Our ICH-compliant document templates allow efficient document development, and can be easily customized to meet a client’s needs. We have writing experience in more than 90 different therapeutic indications. We guarantee that we will meet your timelines and provide an outstanding quality product.

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