Medical writing

Our medical writing team works to integrate the medical and statistical results of your trials into an electronic or paper document that meet the needs of clients’ and regulatory requirements.

Medical writers are qualified to MSc or PhD level, undergo regular training and have a wealth of experience in writing a comprehensive range of documents. They have access to cross-functional professionals internally with whom they collaborate on statistical consultancy and data management areas, so that the end result is a holistic, customised document.

The documents produced are wide-ranging and aimed at many different audiences, from corporate boards of directors, consultants and medical representatives, to regulatory authorities and the general public. We appreciate the importance of targeting our medical writing to specific audiences.

Regulatory medical writing

Our medical writers can prepare a wide range of documents involved in the drug regulatory process including:

  • clinical study reports
  • protocols
  • investigator’s brochures
  • clinical overviews
  • clinical summaries

All our regulatory writing is done in accordance with our SOPs (or, if you prefer, your SOPs) to GCP-compliant standards.

We take the content of our medical writing seriously, and always make sure that the documents we produce are scientifically rigorous. When writing clinical study reports using data supplied to us, our eagle-eyed approach has often uncovered problems with the data or analyses that would have been very awkward and costly to correct at a later stage: for example, inappropriately calculated statistical hypothesis tests that could have led to the wrong conclusions had they not been corrected.

Clinical study reports

Our team of medical writers has considerable experience writing clinical study reports. We ensure that the report:

  • Is fully compliant with International Conference on Harmonisation (ICH) guidelines
  • Is prepared to either a client specific format or to the Dianthus Medical house style
  • Is clearly written throughout to ensure there are no ambiguities
  • Presents the findings of the study in a clear and concise manner
  • Succinctly discusses the clinical relevance of the results and highlights any unexpected findings or potential problems
  • Undergoes thorough QC to ensure accuracy and consistency
  • Is based on sound data, and will flag up any problems in the data we identify as we write the report

Protocols

Dianthus Medical can help you with the writing of study protocols, ensuring that:

  • The methodology and planned statistical analyses are optimised for the specified study objectives
  • The protocol is free of all possible ambiguities that might impinge on the conduct of the study
  • The study will adhere to guidelines for Good Clinical Practice (GCP) and other ethical considerations
  • Your clinical trial has the best chance of being approved by the appropriate International Ethics Committee (IEC) or International Regulatory Board (IRB)

Editing and proofreading

Dianthus Medical offers a comprehensive editing and proofreading service. We can ensure that the clarity, accuracy, and content of your document meet the highest standards.

Proofreading and copy editing

  • Correct spelling, grammar, syntax, and punctuation
  • Ensure internal consistency and accuracy
  • Format the manuscript according to the target journal’s Instruction to Authors or the Uniform Requirements for Biomedical Journals

We will check that all tables and figures are:

  • Consistent with the text
  • Presented in the most effective manner
  • Complete with appropriate titles, legends, axis labelling, and footnotes
  • Correctly numbered and cross-referenced in the text

Substantive editing

  • Re-organise material and re-write sections as necessary, to improve clarity, logic, and emphasis
  • Eliminate redundancies, repetitions, and irrelevancies
  • Tailor the manuscript to a specific target audience
  • Ensure all information is accurate, current, and adequately referenced
  • Use colour coding, tracking, or Microsoft Word comments to allow authors to examine editorial changes

Data presentation

Our skills in data presentation are reliable, secure and proven and ensure your documents present their data in the most effective way. Almost all medical writing projects involve the presentation of complex numerical data. The clearest and most effective way of presenting data can vary greatly from one set of data to the next, and may take the form of simple text descriptions, tables, or graphs.

Our medical writers have a wealth of experience in choosing the best way to present data, to ensure that your message is delivered clearly. We have a range of graphing software, producing publication-quality graphs, and the expertise to draw the best graph for your data.

Where the results of complex statistical analyses need to be presented, our medical writers have access to our in-house statisticians to help them navigate the data.