NUANCES OF SCIENTIFIC MEDICAL WRITING

Scientific medical writing involves writing detailed information about the basic medical sciences, drugs and latest technological innovation in the field of medicine for a range of audiences including medical specialists and health care professionals. This scientific information is written for publication in the medical journals, medical news, and regulatory documents.

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NEVER MISS THESE WHILE WRITING THE “COMMON TECHNICAL DOCUMENT (CTD) FOR PHARMACEUTICAL”

Scientific Regulatory writing is a complex process due to its dossier size, data complexity, and submission deadlines and it requires specialized domain-specific knowledge, understanding of drug development process, pharmacology, statistical and writing skills to develop superior regulatory documents as per the exact requirements of the regulatory authority. Besides, the scientific writer must be familiar with technical guidelines prevailing in countries like European Union (EU), USA, Japan that includes ICH E3 to write clinical study reports, periodic safety reports (ICH E2C), publication guidelines (e.g. CONSORT, STROBE, PRISMA), the International Committee of Medical Journal Editors (ICMJE) guidelines for manuscripts. Common Technical Document(CTD) for Pharmaceutical The Common Technical Document (CTD) is an international standard for the summary documents relating to quality, safety and efficacy information of medicinal products. The CTD is mandatory for the registratio

MEDICAL WRITING FOR REGULATORY SUBMISSION IN CLINICAL RESEARCH AND ITS CHALLENGES

Regulatory medical writing in clinical trials requires medical writers to possess sufficient knowledge of the regulatory guidelines of concerned authorities of specific countries and needs to have dedication and commitment to handle large volumes of regulatory data. A professional regulatory writer needs to have sufficient understanding of the drug development process to determine the important documents that need to be written and submitted for regulatory submissions. Click Here to Read more

CHALLENGES IN THE CRO INDUSTRY: SELECTING A CRO FOR YOUR RESEARCH TRIALS

Clinical Research Organization for Healthcare provides clinical-study and clinical-trial support for drugs and medical devices, wherein many pharmaceuticals, biotechnology, and medical device industries having operations in the Europe Union states outsource research services to CRO to increase efficiency and improve productivity. Clinical Research Organization | PEPGRA Contract Research Organization for Pharmaceutical Industry offer services such as Project, Data and Regulatory Management; Contracting; Medical Writing; and Site and Medical Monitoring, which offers the comprehensive benefits for pharmaceutical companies in Europe Union to make clinical research trials more efficient and cost-effective in testing economic period. CRO industry Challenges The CRO faces multifaceted challenges in the form of Increasingly becoming complex nature of regulatory requirements, GxP compliance, and quality. High levels of risk associated with the CRO business model Increa

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