Monday 14 February 2022

ROLE OF REGULATORY WRITING IN CLINICAL RESEARCH

 

Regulatory Writing


Regulatory medical writing produces a variety of clinical documents across the treatment life cycle, from summarizing and writing data from clinical studies to generating regulatory suggestion documents. After the treatment has been approved by the regulatory authority, post-approval reports on the treatment of patients are generated. Clinical Study Reports (CSR), the Common Technical Document (CTD), and other clinical documents created by medical writing services using regulatory writing services are only a few examples of clinical documents generated by medical writing services utilizing regulatory writing services.


Read more at https://worksure.medium.com/role-of-regulatory-writing-in-clinical-research-ab67f5e17816

Visit http://www.worksure.org/services/medical-writing-and-research-solution/ to know more about our services

Friday 4 June 2021

Medical Writing Companies: Rethink knowledge through collaboration

Medical writing and clinical data management has seen an extensive growth in India these days due to active involvement in the medical and clinical research activities. A number of Contract Research Organizations (CROs) have come into picture that provides its services to multiple healthcare organizations. The medical writing services include preparation of a diverse range of clinical research documents that are required by the stakeholders, including clinical investigators, Institutional Review Boards (IRBs), study coordinators and regulatory reviewers. They also prepare and provide manuscripts that are concise, accurate and are ready for submission to peer-reviewed medical journals for publication. The medical content is prepared according to the needs of the end users that can be physicians, healthcare organizations, pharmaceutical companies, biotech companies, etc. 

For an effective propagation of knowledge from a lab where experiments for a particular study are conducted to the people, medical writing is an essential tool. The knowledge can be conveyed through multiple forms such as publications, newsletters, blogs, websites and pharma-healthcare magazines. One of the important goals of a scientist or clinician is to publish their original research in a peer-reviewed and indexed journal that can lead to the recognition of their novel scientific work. However, the lack of technical and writing skills, institutional hurdles, and time constraints can pose a challenge to the researchers. Due to the linguistic and technical constraints faced by researchers, there have been the growth of medical writing companies that can be contacted for collaboration.

The first step for preparing a manuscript is to choose a particular journal for publication depending on the study type and target reader. Other factors that can be kept in mind while choosing a journal for publication are publication fee, indexing, open-access, impact factor and editors and editorial board members. Some of the well-known journals provide an “open access” option to the authors, wherein if the manuscript is published, it is accessible to all the readers online free of cost. However, the authors need to pay a certain fee to make their manuscript an open access article. However, a number of ‘predatory journals’ are also available that lack basic industry standards, sound peer review practices, and solid basis in publication ethics. It is important to identify and distinguish the predator journals from genuine journals and avoid selecting them for publication. To establish the content or context of the work, a thorough literature search and review is required. The focus of literature survey is to collect and discuss the published information and existing literature in their fields of expertise.  It is important to identify reliable sources of information in order to produce a high-quality manuscript. The content of the manuscript should be interconnected in meaningful paragraphs and should be prepared as per the author’s guidelines of the selected target journal. The guidelines also include the instructions specifying which format has to be used to list the references at the end of the manuscript. The referencing can be done manually or referencing tools such as EndNote™ and Mendeley™ may be used to organize the references as per a particular format listed in the author’s instructions.

It is a responsibility of the author that can also be a medical writer of a CRO to avoid any kind of plagiarism in the manuscript. It is a serious threat to scientific publications and is defined as “theft or misappropriation of intellectual property and the substantial unattributed textual copying of another’s work and the representation of them as one’s own original work” by the office of Research Integrity. To prevent plagiarism, it is important to develop strong writing skills with proficiency in writing in one’s own words and simultaneously conveying the ideas effectively to the reader. However, when quoting available evidence, the content has to be substantiated with appropriate references. Further, numerous plagiarism detection tools are available and can be used to check the extent of plagiarism in the manuscript prepared before it is submitted to the journal for reviewing. Once the manuscript is written, referenced, formatted and checked for plagiarism, it is submitted to the journal for review.

Before accepting the manuscript, journal verifies the authenticity of the research work by the process of peer review, after which it is decided whether the manuscript is suitable for publication or not. The peer review process is carried out by experts with similar area of expertise. Also the journal checks the appropriateness of references used, plagiarism, presence of grammatical errors and the absoluteness of the scientific material. In case of any discrepancy, journal editor returns the draft article to authors for revision and if the revised article is found to be correct in all manners, it get accepted and published in the concerned journals.

WorkSure® provides a wide range of high quality medical writing services and has team of qualified and experienced Medical Writers that are well equipped to write scientific documents and manuscripts that are clear, concise, plagiarism free and thus are of high quality.

Monday 31 May 2021

Role of Extensive Documentation in Smooth Conduct of Clinical Trials

 

The success of a clinical trial largely depends on the proper documentation of each and every event of the trial. A number of essential documents are required to be maintained for evaluation of the conduct of the trial as well as the quality of the data produced. It is important to note that all the documents produced should be compliant with the recently updated guidelines and regulations.

WorkSure® aims in providing pharmaceutical and medical device companies, a complete, accurate, concise, timed, dated and extensive documentation for smooth conduct and management of clinical trials. We at WorkSure® support in planning, performing and communicating research through preparation of various clinical, regulatory and educational documents viz. Protocol, CRF, Investigator brochure, ICF & other trial related document preparation, editing and reviewing documents prepared by sponsors, preparation of Standard Operating Procedure (SOP), developing quality assurance and quality control (QA/QC) plan, clinical study reports, abstracts and publication writing, poster/presentations for conferences, systematic reviews as well as Meta-analysis for submission in peer-reviewed journals. The staff of WorkSure® associated with medical affairs and clinical research is trained, experienced and well-versed with the medical terms and is capable of filling the void of inadequacies in documentation.

Read more at http://www.worksure.org/clinical-trials-extensive-documentation-pharmaceutical-companies/

Friday 3 June 2016

Medical writing services: Delivering medical information to general public, physicians or regulators



Medical writing has become established as an important function in the healthcare industry, since it requires specialized knowledge and skills to be able to write scientific documents in a clear and lucid manner. It is the discipline of writing documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines or news articles. Medical writing takes shape of books, chapters, abstracts, grant applications, patient case report and journal articles (manuscript). 

Different types of medical writing is meant for a distinct set of audience, e.g. medical professionals, patients & general public, medical sales representatives or drug regulators. Hence, the presentation of documents, language and the level of technical information has to be in accordance with the understanding of the respective audience. In addition, documents for regulatory submission are required to fulfil set formats and structures, and their contents are guided by regulatory rules and guidelines. 

The basic pre-requisite for becoming a medical writer is familiarity with medical concepts and terminology and ability to write. A competent medical writer should have good understanding of scientific, pharmaceutical and medical terminologies, command over english language and grammar, modern literature survey tools, presentation, methods of research data, publishing, reviewing, and editing requirements. In addition to the basic requirements, one needs domain knowledge, technical guidelines used for regulatory submission, basic skills in statistics and medical & therapeutic area knowledge for reproducing high quality document. A medical writer involved in the preparation of these documents needs to be conversant with the regulations and prescribed formats for such type of documents. Ethical & legal issues should also take into account to give truthful and complete information including negative findings, following copyright laws, not indulging in plagiarism, following authorship criteria for research manuscripts, and respecting journal review process
Medial writers mostly work with the pharmaceutical industry. However, there are many other setting in which medical writers are required viz. pharmaceutical/healthcare product companies including medical device companies, contract research organizations (CROs) & business/knowledge process outsourcing companies (BPOs/ KPOs), Scientific content and healthcare communication companies, media & publishing companies and medical journals academic medical institutions, medical/scientific societies and healthcare websites.
Recently a new medical writing field has evolved as Pharmacovigilance (PV) medical writing. This new field is not limited to only preparation of Periodic safety update report (PSUR) in the post marketing phase of products life cycle. In fact PV medical writing impacts on the clinical development and post marketing phases as well as making a relevant contribution to submitted documents required before the regulatory authorities for grant of marketing authorization. Recently in a survey, medical writing is ranked fourth most frequently outsourced service. The demand for medical writing is growing steadily over the years. The pharmaceutical and healthcare industry offers number of job opportunities for medical writers. Graduates and post-graduates in life sciences who have the right skills and aptitude can consider taking up medical writing as a full-time profession.

We at WorkSure® are committed to deliver authentic medical writing services to our clients with proof-reading, medical editing and  medical knowledge support.