About Us

Proper Medical Writing (PMW) is a medical writing consultancy founded in 2009, with a firm position in the European market. Our company prides itself on its high intellectual capital, expertise, and experience, resulting in the excellent quality
of our services.

PMW’s knowledge of the medical field has inspired trust among academics, pharmaceutical and biotech companies,
clinical research organizations (CROs), research institutes,
scientific societies and professional associations.

How we can help you

PMW specialises in editing manuscripts for peer-reviewed publication; preparing clinical trial documentation, including support in study design; performing statistical analyses; translating scientific texts; reporting from advisory boards and other expert meetings; and running workshops and training sessions. PMW services cover all clinical areas, presenting an extensive portfolio in oncology, endocrinology, pulmonology, cardiology, infectious diseases, neonatology, diabetology, gastroenterology, gynaecology, haematology, intensive care, nephrology, neurology, paediatrics, pharmacoeconomics, psychiatry, radiology, rheumatology, surgery, transplantology and many others.

PMW supports the development of pharmaceutical products and medical devices.

We provide professional assistance in the preparation of:

  • manuscripts
  • conference reports
  • monographs
  • commentaries
  • presentations
  • posters
  • patient information
  • educational articles for patients
  • content for medical websites (including those that are product-specific) 
  • lay summaries

 

We also perform:

  • medical database searches
  • medical writing for the internet
  • administration of health-related websites
    (production and management of the content, search engine optimisation, usability optimisation)

Meet our team

The PMW team consists of experienced professionals from various medical and bioscience-related backgrounds. Many of them have higher degrees (MD or PhD), and graduated in more than one life sciences field. Thanks to a broad portfolio of specialists, we can ensure the appropriate selection of expert teams, which lead by a project manager guarantees optimum results.

Maciej is Chief Executive Officer of Proper Medical Writing. For several years he held key management positions in a number of international corporations (Pharmacia & Upjohn, Hexal, Agfa Gaevert) and Polish companies (Multikino). Maciej is a member of the Polish Association for Good Clinical Practice (GCPpl). Additionally, Maciej is a board member of the Polish Humanitarian Action (PAH).

Maria is a paediatrician and author of 80+ peer-reviewed publications, with more than 20 years of global experience in the pharmaceutical industry, including its marketing, medical and R&D sectors.
She is a member of the European Medical Writers Association (EMWA), European Association of Scientific Editors (EASE), European Society of Endocrinology (ESE), and Growth Hormone Research Society (GRS).

Karolina is responsible for the preparation and edition of scientific texts and project management at PMW. She undertook many years of research at the Medical University of Lodz, where she received her doctorate degree in medical sciences and the title of specialist in medical laboratory diagnostics.
She was also the secretary of the editorial board of the journal “Folia Medica Lodziensia” and the secretary of the board of the Polish Neuroendocrinology Society. She is a graduate of Medical Analytics
at the Medical University of Lodz.

Dorota is responsible for PMW’s marketing activities, training organization and office management.
She is a graduate of the Warsaw University of Physical Education, Faculty of Rehabilitation and SGH Warsaw School of Economics. She has worked at the Institute of Oncology and varius Rehabilitation Clinics, and conducted many projects within her own businesses. Dorota also served as Public Relations and Micromarketing Head at Citibank. Dorota is a member of the Polish Association for Good Clinical Practice 

Agnieszka has been working for PMW since 2013. She’s an expert on clinical trial documentation
in drug-related projects and peerless at formatting. Agnieszka graduated from the Faculty of Psychology
at the University of Warsaw and undertook postgraduate studies at the Faculty of Management
and Communication at the Jagiellonian University. Before she started working at PMW,
Agnieszka was the assistant editor of the journal “Medycyna po Dyplomie” at Medical Tribune Polska.
She has completed numerous training courses related to medical writing and regulatory documentation.

Małgorzata  assists medical device manufacturers in obtaining CE marking for products.
She is also responsible for writing scientific publications, posters, presentations, and advisory board reports. She is a member of the Polish Association for Good Clinical Practice (GCPpl) and the European Medical Writers Association (EMWA), and has participated in many workshops at EMWA conferences.
She is a graduate of the Faculty of Health Sciences at the Medical University of Warsaw
(Public Health and Dietetics).

Michał is responsible for project management at PMW and specializes in the preparation of reports
from Advisory Boards, scientific publications, and clinical trial documentation. Michal is a graduate
of the Faculty of Health Sciences at the Medical University of Warsaw in Dietetics and is currently completing PhD studies in Microbiology. He is the author of publications and conference
reports on anaerobic bacteria.

Urszula is responsible at PMW for medical writing and for regulatory writing in the domain of medical devices as well as for project management. She is a graduate of Faculty of Biology at Warsaw University and obtained a PhD degree in medical biology at the Medical University of Warsaw. She has extensive experience in conducting scientific research in the field of immunology and experimental rheumatology and has authored or co-authored over 30 scientific articles and conference communications.
Her professional experience in the pharmaceutical industry includes regulatory and medical writing
as well as work in a global regulatory affairs department for medical devices.

Dorota coordinates medical writing projects and assists in editing and reviewing original research papers, review articles, case reports, Advisory Board reports and conference posters. She is a graduate
of the Faculty of Management at Koźminski University in Warsaw, and earned a master’s degree
in Public Health at the Medical University of Łódź. Dorota is a member of both the Polish Association
for Good Clinical Practice and the European Medical Writers Association (EMWA) and has participated
in a variety of workshops at EMWA conferences.

Diana is a Medical Writer, a Project Manager, and leads Human Resource activities. Diana is specialized
in Advisory Board reporting, the editing of scientific texts and multimedia presentations. She is a member of the Polish Association for Good Clinical Practice and the European Medical Writers Association (EMWA). She graduated from the Faculty of Pharmacy at the University of Warsaw.

PMW ethical and quality standards

To meet the ethical requirements for reporting medical research, PMW follows the relevant good practices
and guidelines, and has established internal procedures regulating the principles of cooperation with authors.
In addition, the joint position statement of the American Medical Writers Association (AMWA), the European Medical
Writers Association (EMWA), and the International Society for Medical Publication Professionals  (ISMPP)governs
the cooperation between the medical writers at PMW and authors.

Good Publication Practice

PMW complies with the Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP3)2. According to these guidelines:

  • Preparation of articles is carried out in close collaboration with the author.
  • All co-authors must agree to use the services of PMW.
  • Authors must acquaint themselves with the changes introduced by the medical writer or the editor and should accept
    the final version before sending the article to the journal.
  • Authors can transfer the administrative aspects of preparing the article for publication or public presentation to the medical writer or editor.
  • The medical writer does not usually meet the criteria for authorship as defined by the International Committee of Medical Journal Editors (ICMJE)3; but if he/she has made a substantial contribution (e.g., in the interpretation of results or a major review of the literature) and is ready to take responsibility for at least one aspect of the publication, then he/she should be listed as a co-author.
  • Statisticians provide a significant intellectual contribution; therefore, they should be listed as co-authors according
    to the GPP3 guidelines.
  • The editor should make sure that the authors include disclosure statements, including clauses on conflict of interest, research funding, contributions and acknowledgements.
  • The editor has a duty to make every effort to ensure the accuracy and reliability of the publications in the field in which
    he or she collaborated with the authors.

Other standards

PMW follows the ICMJE recommendations3, the ICH (International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use) standard4, the Good Clinical Practice (GCP), Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (ICH E6) standardthe Guideline for Industry: Structure and Content of Clinical Study Reports (ICH E3)6, and other standards as applicable.

Medical writing vs ghostwriting

Medical writing (editing or writing of medical texts) is not the same as ghostwriting (employing a “ghostwriter”).
The Association of American Medical Colleges is opposed to equating the use of these two services, and it states
that “transparent writing collaboration with attribution between academic and industry investigators, medical writers,
and/or technical experts is not ghostwriting”.7 Indeed, the articles on ghostwriting that are cited in the GPP3 guidelines8-10
stress that a medical writer listed in the Acknowledgements cannot be considered a ghostwriter.

Authorship criteria

According to the ICMJE guidelines,3 the authors of the publication are those persons that meet the authorship criteria.
These persons must have:

  1. significantly contributed to the conception or design of the work; or the acquisition, analysis, or interpretation of data
    for the work; AND
  2. significantly contributed to drafting the work or revising it critically for important intellectual content; AND
  3. approved the final version to be published; AND
  4. agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity
    of any part of the work are appropriately investigated and resolved.

Authors must meet all four of the above criteria. Moreover, any other person who also meets the criteria should be included
in the list of authors.

In most publications on clinical trials, the medical editor, who was not involved in the study design, data analysis or interpretation of findings, does not qualify to be called an author according to the ICMJE criteria. As long as editors collaborate closely
with the authors mentioned by name, there are no ethical contraindications to using their services. Medical editors employed
by the companies funding the project may be involved in the creation of publications.3 Their contribution to the work
and their relationship with the sponsor should, however, be disclosed, as well as the information about the financing
and organization of research.

Quality standards

To ensure high-quality reporting of medical studies and their results, we follow the recommendations appropriate
for the type of reported study, e.g., the Consolidated Standards of Reporting Trials (CONSORT) for clinical trials11
and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for observational studies.12
Moreover, PMW has developed an internal quality management system (QMS) designed to ensure that all services provided by PMW are of high quality, meet the client’s requirements, and are produced efficiently.13

  1. AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers. Medical Writ 2017;26:7-8. Available at: https://journal.emwa.org/writing-better/amwa-emwa-ismpp-joint-position-statement-on-the-role-of-professional-medical-writers/
  2. Battisti WP, Wager E, Baltzer L, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med 2015;163 461-4. doi:10.7326/M15-0288
  3. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, International Committee of Medical Journal Editors. Updated December 2019. Available at: http://www.icmje.org/recommendations/
  4. ICH, European Medicines Agency. Guideline for good clinical practice E6(R2). Updated December 2016. Available at: https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice
  5. ICH, Food and Drug Administration. Guidance for Industry: E6 Good Clinical Practice. 1996. Available at: https://www.cc.nih.gov/ccc/clinicalresearch/guidance.pdf
  6. European Medicines Agency. ICH Topic E 3: Structure and Content of Clinical Study Reports. 1996. Available at: https://www.ema.europa.eu/en/ich-e3-structure-content-clinical-study-reports
  7. Association of Medical Colleges. Industry funding of medical education. Report of an AAMC task force. 2008. Available at: https://www.aamc.org/system/files/c/2/482220-industryfundingofmedicaleducation.pdf
  8. Woolley KL. Goodbye ghostwriters!: How to work ethically and efficiently with professional medical writers. Chest 2006;130:921-3. doi:10.1378/chest.130.3.921
  9. Hamilton CW. Differential diagnosis: distinguishing between ghostwriting and professional medical writing in biomedical journals [Letter]. JAMA Intern Med 2013;173:2091-2. doi:10.1001/jamainternmed.2013.10420
  10. Stretton S. Systematic review on the primary and secondary reporting of the prevalence of ghostwriting in the medical literature. BMJ Open 2014;4:e004777. doi:10.1136/bmjopen-2013-004777
  11. CONSORT. Consolidated Standards of Reporting Trials. 2010. Available at: http://www.consort-statement.org/
  12. STROBE. Strengthening the Reporting of Observational studies in Epidemiology. Available at: https://www.strobe-statement.org/
  13. Proper Medical Writing Quality Manual – internal document