Medical writing

Our team of medical writers work 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.

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

Regulatory medical writing

We 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)

Medical communications

We offer a wide range of medical communications services, primarily manuscripts for publication in peer-reviewed medical journals, but we also have extensive experience preparing abstracts, slide presentations, and posters for conferences, and other documents such as monographs or training manuals. We have also been involved in writing material for websites and CD-ROMs, and understand the specific requirements for this type of communication media.

We are careful to ensure that our documents are produced to the highest ethical standards. We are very aware of the ethics of the involvement of medical writers in peer-reviewed publications, and we were intimately involved in writing recent guidelines on the subject.

Strategic publication planning

“Effective communication is the ultimate, but often daunting, aim of any piece of medical research or clinical study”.

Goodman NW and Edwards MB. Medical writing: a prescription for clarity. 1997 Cambridge University Press.

The timely and targeted publication of clinical research is crucial for future commercial success. Dianthus Medical can assist you to design a strategic publication plan to maximise the impact of your research findings, collaborating with you to produce:

  • Written materials for journals and scientific meetings: manuscripts (original research articles and review articles), abstracts, and poster and slide presentations
  • Written educational materials: patient information handouts and drug information brochures

We can ensure you get the right messages to the right audience at the right time, all while respecting the highest ethical standards.

Manuscripts for publication

Publication in peer-reviewed journals is crucial in both academia and industry; however, the publication process can be time consuming and frustrating. Dianthus Medical offers a fully comprehensive and flexible manuscript writing service that quickens your path to publication. We also operate to the highest ethical standards, thus reducing the risk of adverse publicity that can result if any corners are cut.

The following list is provided as a guideline to the major steps involved in the production of a manuscript, from conception to publication. We can help you with one or more of these steps, tailoring our service to meet your individual requirements.

Project specification

We discuss your requirements for the manuscript, identifying key messages, target audience and journal, and proposed timelines. In the case of original research articles, you provide us with the original data in your chosen format (hard copy or electronically). If required, we can design a strategic publication plan, putting the proposed manuscript in the context of a long-term publication strategy. It is important to ensure that the author list of the paper is specified at the early stages of manuscript conception, to ensure that authors are able to contribute meaningfully to the development of the paper from the beginning, thus avoiding any ghostwriting.

Literature searching

If necessary, we use online databases such as MEDLINE¯ and EMBASE¯ to access relevant current and archived literature.

Manuscript outline

We provide you with a draft manuscript outline, detailing material covered in the paper, relative weighting of different sections, and key references. Approval of the outline by all manuscript authors will greatly ease the approval of drafts of the full manuscript.

Draft manuscript

On approval of the manuscript outline, we proceed with writing the first draft of the manuscript. We place emphasis on the clarity, accuracy, and consistency of the manuscript, ensuring that your message is presented in the most effective way. Care is taken to format the text in accordance with the style requirements of the target journal. This draft version is then sent to the authors for approval.

Final manuscript

On receipt of comments on the draft manuscript, we incorporate the suggested changes, if any, into the manuscript, producing a final version ready for submission to the target journal. Arrangements can be made for Dianthus Medical to compile a submission package for you if required.

Abstracts

We can assist you in the submission of written abstracts to scientific conferences, carefully adhering to all specified requirements, and presenting your research findings clearly, concisely, and effectively.

Once the abstract has been accepted, we can help you to prepare a presentation in a specified format: poster or slide presentation.

Abstracts can either be standalone projects or part of a strategic publication plan.

Poster presentations

The aim of a poster presentation is the communication of research findings in a simple, accurate, and eye-catching manner. We can work with you to design your poster presentation, carefully formatting your findings to meet the specific requirement of the target conference, and using our data presentation skills to display your data in the most effective way.

If required, we can liaise with designers and printers on your behalf.

Slide presentations

The use of clear, concise, and visually impacting slides can assist you to optimally communicate your research findings.

Our team at Dianthus Medical has considerable experience in the design and organisation of effective oral communications. Using Microsoft PowerPoint, we can produce a slide presentation that maximises the impact of your research. In addition to designing the slides themselves, we can write notes to accompany each slide, outlining the major issues that need to be raised when you present it. We can also provide printed handouts of your slides for distribution to interested parties at the end of your presentation.

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.