Medical Writing and Plain Language Summary

Develop accessible, compliant documentation, and communicate with patient and scientific communities.

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Xogene has the right resources to communicate with the right audience

We craft clear, concise plain language documents using expert knowledge, industry best practices, and best-in-class technology. Designed to be visually engaging and patient-centric, our documentation meets the highest standards of scientific accuracy and compliance—powered by AI for fast, precise results.

Clear, informative, and non-promotional summaries of trials

Plain language summaries

Global transparency regulations often require summarized trial results in plain language that is easy to read and accessible to a wide audience. This requirement connects transparency initiatives with the people who benefit from them the most: patients, caregivers, friends, and family. Essentially, all of us.

For sponsors providing plain language summaries, Xogene provides the critical skills to bridge the gap between clinical trial information and the patients who participate in them.

Our transparency specialists extract key scientific data, translate medical texts into plain language, and package the summary in a visually appealing format. With the help of our in-house tools, our specialists, graphic designers, and plain language writers ensure that the trial information is summarized simply and accurately without being promotional.

Our services include:

  • Template development for plain language documents in line with your branding guidelines
  • Plain language summaries of protocol synopsis and results
  • Plain Language Summaries of Journal Publications (PLSPs)
  • Graphic design services for all documents
  • Quality control review of plain language documents
  • Translation into 200+ languages
  • Patient panel reviews of plain language documents
Write your protocol and CSR with downstream activities in mind

Regulatory and clinical writing

We support your regulatory and clinical writing needs from the earliest phases of development through post-approval. We believe that high-quality submission is the key to securing approval, and we ensure that every document is meticulously crafted to meet regulatory standards. Assisted by AI agents that produce first drafts of your materials from protocol summaries and registrations, we can handle the hundreds of thousands of pages it takes for a treatment to go from discovery to market.

Our services include:

  • Study Protocols (Phase I to IV)
  • Clinical Study Reports
  • Investigator Brochures
  • ICH GCP Compliant Clinical Study Reports (CSRs) (Phase I to IV)
  • Clinical sections of the Common Technical Document (CTD) including summaries and overviews
  • Patient Safety Narratives
  • Informed Consent Forms
  • Safety Reports
  • Summary of Product Characteristics (SmPCs)
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