Medical Writing

Best Practices of Drafting Clear, Effective, Concise Documents

Medical writing is an integral part of clinical research. Xogene offers a comprehensive suite of medical writing and clinical trial transparency services, including regulatory and clinical writing, scientific writing, and medical information and education.

Our Medical Writers include a team of highly qualified, M.D., Ph.D., PharmD, and Master level writers with experience across multiple therapeutic areas. Our team works closely with key stakeholders across all departments, including Biostatistics, Pharmacovigilance, Regulatory, Clinical Data Management, and Project Management. To ensure that our high standards for medical writing are upheld, we have a rigorous quality assurance process. Each document is checked for:

  • Clarity and conciseness
  • Accuracy and grammar
  • Objectivity

Regulatory and Clinical Writing

Write Your Protocol and CSR with Downstream Activities in Mind

We support your regulatory and clinical writing needs from the early phases of development through post-approval. We believe that quality submission of documents is the key to a promising approval. Taking your new medicines from discovery to market is a long road filled with hundreds of thousands of pages of documentation. This documentation must be written accurately, while also adhering to regulatory requirements.

How we help:

  • Study Protocols (Phase I to IV)

  • 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 Form

  • Safety reports

  • Summary of Product Characteristics (SmPCs)

Scientific Writing

Clear Communication and Publication Strategy are the Keys to Effectively Reporting Your Results

While a robust document is key to properly inform regulators and patients about your studies, many companies often overlook the importance of the documentation in the years following the trials. Our scientific writing services will meet your communication and publication needs before, during, and after clinical trials.

How we help:

  • Conference materials (abstracts, poster presentations, and slide sets)

  • Manuscripts

  • Educational material for patients, healthcare professionals, and pharmaceutical industry personnel

  • Product website content (for both scientific and patient audiences)

  • Lay Summaries

Medical Information and Education

We Help You to Ensure the Medical Community Understands Your Data

We have a wide breadth of experience and knowledge working with Top-20 Global Pharmaceutical Companies and Academia. The documents produced at Xogene undergo thorough quality review to ensure the scientific value of the research is well-communicated.

How we help:

  • Lay Summaries

  • Continuing education (CE) activity manuscripts and slide decks

  • Outcomes data compilation and summaries

  • Medical Response Documents

  • Q&A Documents

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