Management of Multiple Projects In Medical Writing

What are Medical writing services?

Medical writing services deals with Medical Science which includes clinical research reports, content for healthcare blogs, newsletters, newspapers, and news. Writing a research procedure and/or a clinical study report (CSR) for a project is part of regulatory medical writing. In a Clinical Research Organization (CRO), a Regulatory Medical Writer is normally involved at the beginning (writing a study protocol) and/or end (writing a clinical study report (CSR)) of a project. When the team works together to reach critical deadlines at the start and end of a clinical trial, it may be the most difficult time for them.

 How to manage multiple projects efficiently in Medical Writing?

 Priority to Documents

Determine which documents are the most important and have the greatest effect on a report. Give them priority over those with the smallest effects.

Timeline

Draw a timeline of all of the overlapping tasks. Manage the time efficiently by determining which documents are the most critical (and therefore have the greatest impact in a study) and which can be postponed with the least impact.

Document Completion Process

At the start of the research, explain the entire document completion process to the study team and ask them if any improvements need to be made. Show them how major changes, ad hoc evaluations, and other factors will impact schedules in vital QC time.

CSR Methodology

If the client has finalized the protocol and statistical analysis strategy, write the methods portion of the CSR. Do as much work as possible off the critical path.

Meeting with the Research team

Hold a results analysis meeting with the research team to show them how you expect to present the data while writing CSRs. This will help you understand exactly what the research team is looking for and how it should be portrayed.

 Assistance

If deadlines are approaching, make use of your colleagues. As the lead medical writer, you will, for example, write the efficacy findings more accurately when delegating a huge in-text table or the protection section to a colleague.

 Discussion

Call the research team for a live meeting and discussion once you’ve finished the first draft of your paper. Any changes in the timeline should be communicated to the QC and peer reviewers. If you want to deliver all of the documents on time, make sure that all of the testers are aware of when they must complete the work, how long it will take, and how urgent the project is.

Feedback

Finally, no matter how much work you have, be frank with your clients; if they have unreasonable standards, work with them to improve them. Wait until you’ve received all of the client’s feedback before responding, and double-check that you know who the signatories are. A consumer is more likely to make changes to ensure that the document is delivered on time

Conclusion

When a team is dealing with several submissions in a short amount of time, or even simultaneous submissions, confusion about timetable organization, Medical Writing Publication can be dealt efficiently with the above steps.

Medical Writing As a Career

Some of the most rewarding career paths are ones that people never intended to take. This is frequently the case for medical writers who did not consider this flourishing field when they began their careers. Medical writing may be an organic change for people with a medical, life science, or academic background seeking to move away from the lab or healthcare institutions because there are no clear qualifications. Passionate writers will find a rewarding career in this inspiring and unique field. Medical writing is in high demand in the communication, healthcare, and pharmaceutical industries.

What Is Medical Writing?

Medical Writing is communicating Clinical & Scientific Data clearly and effectively.

Scope of Medical Writing

  • Clinical Research Documentation
  • Content Writer for Health Care
  • Article writing for Healthcare Magazines and Journals

 

Types of Medical Writing

Medical Writing is mainly of two types:

Regulatory and Research Related Writing

  • Focused mostly on Medical & Pharmaceutical Industries.
  • The main audiences are people performing Clinical Trials, Government Regulatory Authorities.
  • The objective is to attain and maintain marketing authorization for new drugs, therapies, medical devices, and other health products.

 

Medical Communications

  • Documents about New Drugs, Therapies, Medical Devices, or other health products.
  • Examples are Scientific Manuscripts, Product Monographs, Conference Abstracts, Posters, Educational Material.

 

What are the Skills Needed to be a Medical Writer?

  • Domain Knowledge – Health Care Knowledge
  • Data Integrity – Data Analysis
  • Clarity – Communication Expertise
  • Language Skills – Scientific Expertise
  • Follow Ethical Standards
  • Knowledge about Legal Concerns
  • Good Writing Skills
  • Literature / Reference Search – Document Review Process
  • Interpretation & Presentation – Document Expertise
  • Formatting & Editing
  • Reviewing Published Paper

 

Courses for Medical Writing

Some of the Medical Writing Certification Courses are as follows:

  • PG Diploma in Medical Writing – 12 Months
  • Professional Diploma in Medical Writing – 4 to 6 Months (Online)
  • Advanced PG Diploma in Clinical Research & Writing – 6 to 8 Months
  • Certificate Program in Medical Writing – 6 Months
  • Free Courses

 

Job Titles for Medical Writers

  • Medical Expert
  • Editorial Manager
  • Senior Writer
  • Associate Writer
  • Junior Writer

 

Roles of Medical Writers

  • Proofreads regulatory documents and clinical documents.
  • Coordinates with Medical professionals.
  • Helps to write research articles.
  • Creates Educational and Informational materials for the Medical kits.
  • Writes Research Findings
  • Creates Standard Operating Procedures for Medical company’s planning

 

Where do Medical Writers work?

  • Pharmaceutical Sector
  • Medical Communication Agencies
  • Contract Research Organization
  • Journal Publishing
  • Biotechnology Sector
  • Medical Device Sector
  • Medical Translations
  • Other (Academic) Sectors

 

Benefits of being a Medical Writer

  • Challenging & Stimulating Work ENVIRONMENT
  • Always learning new things
  • Satisfaction in being an important part of a team
  • Lead groups of Multifunctional Professionals
  • Opportunities to travel

 

Conclusion

Medical Writers do Scientific Documentation. Medical Writing involves the above-mentioned skills and offers a good career. People with medical knowledge and writing skills would have a lot of opportunities.

Benefits of Outsourcing Medical Writing Projects

Outsourcing Medical Writing

Outsourcing scientific and clinical writing assignments lower the staffing needs by lowering the cost of recruiting, training, and retention. Medical device and pharmaceutical companies are increasingly turning to outside vendors to meet their technological and regulatory writing needs for business development.

What are the Stages of Outsourcing?

What And When To Outsource Medical or Scientific Research Paper? 

  • If a team determines that it will need medical writing assistance, the process of outsourcing medical writing activities should begin with a schedule for what documents will be required and when they will be required.

 

Finding And Selecting A Medical Writing Company

  • Ask the right questions and provide the right information to the Medical Writing Company

 

Managing The Services Provided

  • Make sure the writer is an empowered member of the clinical team should be part of managing the ongoing medical writing

 

Evaluating Performance At The End Of The Project

  • It’s crucial to assess the results at the end of the project before deciding whether to work with the same writing company on future projects.
  • Take the opportunity to meet with the main clinical team members and the medical writer after the project’s final activities are completed to share and review everyone’s opinions about how far the partnership went.

 

What are the Benefits of Outsourcing?

Adaptability – The re-appropriated writings from the Medical or clinical research writing firms have a lot of versatility for those who can’t afford to hire their authors.

Increase in profits – When companies outsource to Medical writing firms, they can save money in a variety of ways by minimizing or removing in-house workers and relying on a team of professional outside authors.

Best to focus on your core competency – Most businesses do not specialize in medical writing. The world of medical devices and pharmaceuticals is rapidly changing. By outsourcing, focus can be directed on Core Competency.

Compact writing services – Medical Writers, skilled editors, specialist statisticians, and staff writers make up a competent medical writing team. As a result, you won’t need to employ many people to do the writing, editing, and presentation of the abstract poster. This will help you save even more money.

Documents that adhere to strict regulatory guidelines – Pharmaceutical companies and clinical testing firms must meet the conditions set out by the respective regulatory authorities to introduce a new drug or perform a clinical trial. Medical writing services make it simple to solve this obstacle by sending documents that meet regulatory requirements.

Effective medical communication – Health content writing necessitates knowledge of medical terminologies, as well as experience and technical writing skills. The rethought writing of medical writing experts helps you share your thoughts easily.

Improvement in your sales and services – Medical device ads, product literature, and service brochures can all be outsourced to professional medical writers who can create eye-catching marketing material and increase sales revenue.

Tips for outsourcing medical content writing

  • Clearly describe the need as well as the audience you want to reach.
  • Provide detailed indications
  • outsourcing entails a collaborative effort.
  • Establish realistic deadlines
  • Be ethical 

 

Conclusion

Outsourcing medical writing successfully necessitates selecting medical writers who are not only knowledgeable about the requirements of each paper, but also capable coordinators who can push your clinical teams to present a straightforward, well-argued tale.

 

Making a Firm Decision: “Traditional vs. Open Access Journals”

We all know that making good choices in terms of academics and scientific career is the key to success. Research writing and publications compliment the career of a scientist or an academician. Moreover, publications in reputed (high impact factor) and peer-reviewed journals produces global recognition to their contribution towards the scientific community.

Selecting an appropriate journal to publish your invaluable contribution is the major step in disseminating your research findings. The research ought to be published in the right journal for reaching the target audience with desired impact. However, many researchers struggle to make the right choice while selecting a journal as they get confused between Open access and Traditional Journals. The decision also becomes difficult while considering the journal’s performance (range and impact on audience), cost of publication (Submission charges and Article processing charges) and duration of publication process.

Traditional Journal vs. Open Access Journals: Based on the different factors

Traditional Journals

Traditional journals are those which generally do not levy any fee on authors or contributors for scientific publication. These journals are funded by subscriptions and advertisements and hence, the readers are charged for accessing or downloading any content in the journal.

The comparison between the traditional and open access journals suggests that the traditional journals possess higher reputation as they are not new to the experts in the field and association with reputed institutions and medical centres. However, higher reputation does not mean that it will reach broader audience. Because of high subscription charges for the readers, the content remains exclusive for specific mass and this is also the reason for not receiving desired number of citations after the introduction of Open Access journals.

The traditional journal charges per page for the printed versions which may vary based on the number of colour figures. However, for read only service the readers need to subscribe to the journal with subscription charges ranging from $100 per individual to $50,000 for institutions.

The traditional journal generally takes around 4-6 months for the quality checking and peer review process. The delay in the process is because of the number of articles received and their pending physical printings and distributions.

Open Access

“Open Access” is the idea and practice that created a movement which enabled the journals to provide complete barrier-free and cost-free access to the readers. Providing free access means that the readers can read, download, copy (with prior acknowledgement), share and print the online information available in form of articles.

Based on the different factors for making the appropriate choice, open access is changing the landscape of the research industry and has returned scholarly publishing to its original purpose of “spreading knowledge without any barrier”.

Publishing in open access journals provides greater visibility as it reaches broader audience without any fee. However, as no publication is without any fee, the author is responsible to pay the Submission charges and Article processing charges. Generally, the fees range between $50-$5000 based on the impact and reputation of the journals.

Most of the researchers opt for open access as they may not be popular in their field as, open access circulates the articles to a wider audience using different platforms to reach different researchers in the field worldwide. That is why, most of the traditional journals have now adopted the “Open Access Policy” either completely (full open access) or partially (hybrid open access).

Scientific publication represents the reputation of the researcher and hence the faster you publish the greater is the competitive edge they receive over other competitors. Most importantly, the researcher who gets published first receives the credit for the idea and the manuscript. Open access journals significantly reduce the time of publication with rapid peer review process. However, some researchers doubt the quality of the process and also consider this process as fake.

Role of ManuscriptEdit in helping you to make the correct choice

You might have now understood the pros and cons of each type of journals, but you still might not be completely sure about your choice.

The selection of the journal (whether open access or traditional) should be based on one’s requirement and hence, ManuscriptEdit provides a “Journal Selection Report” service which is prepared by considering the quality, scope and novelty of the manuscript. However, the author can also share their recommendations on the basis of different criteria such as the impact factor, reputation, indexing and cost which needs to be covered. We understand the effort that has been put to produce a quality research paper and hence, we guide the authors to make the right selection for getting the article published in desired journal.

Copyright Myths vs. Facts

The objective of copyright law is to provide a legal framework to assure creators of original work that their artistic talent is fairly rewarded and protected.

The advancement in technology and the Internet has made it much easier for works to be created, published, and copied as well. With increasing digital content, there are many misconceptions regarding the copyright law circulating online. This is an attempt to clarify the myths and facts associated with copyright law.

Copyright covers a wide range of creations that include literary works, artistic works, development software, computer programs, movies, music, etc. There is a myth that one can copy or republish a particular content as long as credit is given to the original owner. But the fact is that the exclusive right to copy content belongs to the owner of the copyright only and no one is entitled to reuse a work in any way unless an explicit permission is obtained from the owner.

It is also assumed that content published online becomes public property as it is in the public domain and it diminishes copyright protection on it. But the fact is that the authors have exclusive right on the published content, so other users should take measures to confirm ownership of the content before publication.

There is a third misconception that any work that doesn’t bear the copyright notice or tag is open to be reused. However, copyright exists in a work from the moment the content is recorded in any fixed and observable form. Non-display of the copyright note does not confer any permission on anyone to reuse that work.

Another area of uncertainty is regarding derivative works. The fact is that such works are still covered by copyright. It is believed that if one modifies or partly uses someone else’s work, it doesn’t breach the copyright law. On the contrary, it is only treated as a ‘fair use’ when a person accesses the work just as a reference.

There is another gray area related to the financial gain from the protected content. It is presumed that a person can use another person’s work if there is no financial gain or profit from it. But in reality, copying someone else’s work is a breach of copyright law, and money is not a consideration in that case.

Many myths persist about fair use, which is an essential right that allows the use of copyrighted material under certain circumstances. Therefore, while creating, sharing, and consuming media on the Internet may be easier than ever before, copyright regulations are still in force and must be respected.

Usage of machine translation software in academic writing

The number of research articles submitted by non-native English speaking authors is increasing rapidly. However, the language barrier and time constraints are hindering their publication in English journals. With an intention to expand the reach of such innovative researches to other scholars and researchers, automated or machine translation software is a trending tool among academicians.

Akin to online proofreading software, the machine translation system is readily available on the web at little or no fee. Software such as Google Translate, Bing Translator, and Babel Fish are widely used in translating content through the rules-based systems. These systems are based on the translation techniques that analyze word patterns in the text in the documents that have been previously published or translated.

Cons of machine translation

Though useful to some extent, machine translation causes several errors in the document, thus affecting comprehension. Some serious mistakes recorded till date include:

  • Unnecessary fragments of the sentences in the translated material
  • Redundant and lengthy sentences creating confusion
  • Phrases ordered in an illogical manner
  • Word-by-word translation instead of contextual translation

The poor sentence structure along with errors in syntax and terminologies result in lack of clarity in the content and affect readability and comprehension. Eventually, the translated manuscripts or articles get rejected by journal editors because of a lack of clarity and coherence.

Machine translation software vs. Human Translators

Automated translation systems have been used for several years with the aforementioned drawbacks. Hence, the idea of utilizing machine translation software, i.e., Google Translate, Bing Translator, and Babel Fish, etc., is a risky one. Conversely, it is more advisable to use the expertise of academic translators to maintain or even enhance the integrity of the research material. Even if more expensive, manual translation services are worth it because they add credence to your manuscript.

Preparing tables for research papers

How to effectively prepare tables for research papers

Tables and illustrations are important tools for efficiently communicating information and data contained in your research paper to the readers. They present complex results in a comprehensible and organized manner.

However, it is advisable to use tables and illustrations wisely so as to maximize the impact of your research.They should be organized in an easy-to-understand format to convey the information and findings collected in your research. The tabular information helps the reader identify the theme of the study more readily. Although data tables should be complete,they should not be too complex. Instead of including a large volume of data in a single unwieldy table, it is prudent to use small tables to help readers identify the important information easily.

Here are some points you should consider before drafting the tables in your research paper:

  • Finalize the results that are required to be presented in tabular form.
  • Include the data or results that are relevant to the main aim of the study without being choosy and including only those results that support your hypothesis.
  • Create each table in a lucid manner and style without cluttering it with in-table citations.
  • Number the tables in a sequence according to their occurrence in the text.
  • Don’t mix tables with figures. Maintain separate numbering systems for tables and figures.
  • Create tables in a storytelling manner. Remember that your tables communicate a story to the reader that runs parallel to the text.
  • If you are using or reproducing tables from other published articles, obtain permission from the copyright holder (usually the publisher) or/andacknowledge the source.
  • Do not repeat the tabular contents in the text again; that will create confusion among readers.
  • Use clear and informative text for each table title.
  • Take extra care while extending the data in your tables. If you have too many tables, consider using them as appendices or supplementary materials.
  • Create tables with sufficient spacing in the layout so that they do not look messy, crowded, or cluttered.
  • Do not forget to spell out abbreviations used in the tables, ideally in the footnotes.

For the reader, a research paper that is dense and text-heavy can be tiresome. Conversely, tables not only encapsulate your data lucidly, but also welcome a visual relief for the reader. They add value to the layout of your paper. Besides, and more importantly, reviewers often glance at your tabulated data and illustrations first before delving into the text. Therefore, tables can be the initial draw for a reviewer and deliver a positive impact about your research paper. If you can achieve an optimum balance among your text, tables, and illustrations, it can go a long way toward being published.

Preparing your figures for research papers

How to prepare your figures for research papers

Often a research paper is embedded with loads of data and complex results and it might not be viable to include all them in the space-constrained paper. Hence, this calls for effective presentation of the information in the form of figures or diagrams. In fact, figures are the most powerful tools that leave a strong visual impact for both reviewers and readers.

Here are few tips on how you can improve the presentation of figures in your research paper.

  • Ensure that the components of the figures are clearly visible including the lines and text.
  • Always use a standard font style and size for the figure text.
  • Every figure needs to have a legend. The legend should support your figure entirely. The reader should be able to understand your figure, paired with its legend, without going to the results or method sections.
  • All abbreviations in the figure legends need to be consolidated and spelt out.
  • All parts of the figure need to be labelled. The symbols, lines, colors, abbreviations, error bars, scale bars, and other components need to be defined and described properly.
  • If you are using photographs of your human subjects, don’t forget to obtain an informed signed consent for the same.
  • Do not be afraid to use lengthy figure and table captions—better that than confusing or incomplete ones.
  • Do not forget to cite the figure that has been taken from another source and supports your present study. Use the same citation style throughout the paper.
  • All journals have their specific requirements for formatting figures, such as file format, font size, font style, image resolution, style of numbering, etc. Adhere to these guidelines before submission. You can learn more about fonts and styles if you are not familiar with them.
  • Cite figures in the main text at the appropriate place where the text is supported by a particular figure.

The figures in your research paper communicate a parallel story to the reader. In fact, the reader can derive a fairly good idea of your paper by just scanning the figures in the paper. Remember that figures are not just tools to beautify your text; they are the heart of your research and an intrinsic part of your research paper. This highlights the importance of organizing the figures well so that they are able to perform as an excellent prop for your text.

Authorship Disputes: Tips to avoid conflicts

Tips to avoid Authorship DisputesAuthorship’ denotes the practice of providing truthful credits for intellectual contributions and innovative concepts. It not only helps authors acquire the credit for the work, but also ensures that they assume responsibility for the research conducted and presented. Moreover, it is perceived as a tool for personal satisfaction, prestige, and especially, a stepping stone in a writer’s academic career. Though the term sounds interesting, it involves high risks and problems in practice.

The Committee on Publication Ethics (COPE) often receives disputes regarding authorship. These cases usually involve disputes like the omission of a deserving junior researcher’s name from the authors’ list or a proposal by a sponsor for including the name of a non-contributing author. However, it also received a shocking complaint from a female author, who said that her name was replaced with that of her boss in the final version when she was away on maternity leave.

Apart from having a direct impact on the publication in question, authorship disputes can also have repercussions on a writer’s fair credit, collegial relationships, future collaborations, and reputations.

Following the adage that prevention is better than cure, the following are some guiding principles to avoid conflicting situations like authorship disputes.

  • Adhere to the authorship criteria of the publication

Each publisher follows specific authorship guidelines enunciated by organizations such as the International Committee of Medical Journal Editors (ICMJE), World Association of Medical Editors (WAME), Council of Science Editors (CSE), Committee on Publication Ethics (COPE), and Good Publication Practice (GPP2). Non-compliance with the concerned guidelines—i.e., unequal application of authorship criteria, granting authorship to undeserving individuals, and/or omitting authorship to deserving individuals—is considered to be a serious offense in the academic world and can be construed as  research misconduct.

  • Hold prior discussions with co-authors

All the authors of a paper should discuss and finalize the authorship order and contributions along with respective responsibilities before beginning to prepare a manuscript and, if possible, even before starting a study.

  • Stick to the plan of action

In few cases, it has been observed that even if the authors have agreed to the sequence of authorship and contributions, fraudulent authors make last-minute changes in the manuscript or research paper just before submission. This leads to conflicts in publishing the paper, and some even end with retraction of the paper. To avoid such anomalies and unpleasant situations, it is advisable to comply with the agreement made between the author and co-authors.

However, even the best plans sometimes fail. So it is better to track and revisit the issues and monitor any changes or modifications in authorship or contributions. If one discovers any changes before publication, it can be revised after discussions with the co-authors. Conversely, if the detection is made post-publication, one can contact the journal along with the written agreements and evidence of contributions, and request for a correction or a retraction of the paper.

Publication Pollution by Predatory Journals

Publication Pollution by open access publication mode

In a commentary published in the Mayo Clinic Proceedings Journal New York University bioethicist Arthur Caplan convokes scientists and physicians to take a stand against predatory publishing, plagiarism, and fraudulent publications, which are polluting the fields of science and medicine. He also warns that if the medical and scientific communities continue to remain in denial of these trends, the trustworthiness, utility, and value of science and medicine will be irreparably damaged.

In this era of digital publication of research works, the popularity of online scholarly journals has led to the emergence of an open-access publishing mode in which authors are often asked to pay to get their accepted papers published. This mode has become so widespread that some online journals have started misusing it. They use deceitful practices to cheat the author and pollute the network of scholarly publications. This is why they are categorized as predatory journals.

When the problem of predatory publications was posed to Jeffrey Beall, the well-known librarian and associate professor at Auraria Library in the University of Colorado in Denver, he stated that researchers, science communication, and science itself are the victims of this publication pollution.

How do such predatory journals thrive?

In the initial stage, these publishers approach authors through personalized and deceptive spam e-mails to persuade them to publish their research works in their journals. They also falsify impact factor rankings to allure researchers and authors. However, they hide the names of the owners, editors, and reviewers, and don’t even disclose their business address. They deliberately hide the fact that an article processing fee has to be paid prior to the publication of the paper. Thus, authors remain unaware about publication charges until they receive the invoice from the publication office. Later, they are forced to pay because of a sense of obligation and the urge to get their research published. This style of publishing pressurizes the author to search for alternative means to cover the unforeseen expense. The publishers also include a list of reviewers and editors on their journal pages without seeking their consent.  The journals pay no heed to the requests of authors to remove those names.

This trauma adds to the highly stressful experience of authors as they struggle to publish their research for better job prospects. In a bid to make their CVs more impressive by increasing the list of published works under their belt, authors fall easy prey to predatory journals.

The eagerness to publish articles has led many authors to the path of open-access publishers operating hundreds of journals. Barely four years earlier, the market share was dominated by larger, long-established institutions, each with 100 or more different journals in the field of science. However, according to a survey mentioned by Cenyu Shen and BoChrister Bjork in their research on predatory publications, approximately 8,000 journals of 963 predatory publishers have published nearly 420,000 articles.

These predatory journals are not only deceiving the authors, but are also polluting the academic and scientific research world. Here are some glaring problems in these predatory publications.

Misconduct in Research

Predatory journals encourage plagiarism, self-plagiarism, image and data manipulation, salami slicing of one research into several papers, and host and honorary authorship. Though some of these practices also occur in legit journals, the frequency is much more in fake ones because the prime driver of spurious journals is revenue growth. Therefore, predatory journals publish articles without subjecting them to a stringent review process. As a result, non-science and fake research articles are published in science journals with manipulative data and findings. This weakens the process of academic research. Moreover, the whole scientific research world experiences a breakdown when such articles are cited in other scientific articles in cyclical effect.

Subpar publications

Predatory journals gradually turn out to be a tool for unscrupulous authors who desperately want to obtain the annual published articles margin in their names. With fake journals offering to publish articles within a short span of time, the complicit authors succeed in publishing subpar articles. They don’t even hesitate to publish articles authored by others in their name.

Sudden blackout of such journals

In case the journal disappears from the academic community, authors not only lose their publishing fee, but also their published research work.

Therefore, in order to shield yourself from this pollution, you must carefully review contracts with your publishers and assess the publisher’s rights and assertions. That will help you ensure a long and durable relationship with your publishers. Even if the process of getting your paper published in well-known real journals is tedious and painstaking, it is definitely worth it to protect your research from being misused.