WRITING GRANT PROPOSALS FOR PHARMA RESEARCH/CLINICAL STUDY

Grant writing is a skill of critical significance to the global pharmaceutical industries and clinical research professionals, as conducting high-quality clinical research studies needs large amounts of funds, which can be obtained by writing successful grant proposals

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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 registr...

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...

THE ROLE OF REFERENCING IN SCIENTIFIC WRITING

The Role of Referencing in Scientific Writing Referencing can be considered as a systematic and scientific technique to define a source of data by presenting a set of information that facilitates a particular text to be easily identified, sought and retrieved. Though referencing would specifically refer to information sources that are included within a scientific paper, the detailed list of sources is presented within the bibliography. There are several styles of referencing that have been in use in the medical, scientific and other domains which would include:- Vancouver The Harvard and APA referencing styles would comprise of including the name of the author and the year of publication while the Vancouver style involves the use of numbers to denote a reference. APA ( American Psychological Association ) Harvard University The Problems The increased number of diverse fields of data for every single material that can be cited often gives rise to re...

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