Title: NUANCES OF SCIENTIFIC MEDICAL WRITING
1NUANCES OF SCIENTIFIC MEDICAL WRITING
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PEPGRA Healthcare Pvt Ltd
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.
2Scientific 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
healthcare professionals. This scientific
information is written for publication in the
medical journals, medical news, and regulatory
documents.
Nuances of Scientific Medical Writing The
important role of scientific medical content
writers is to develop high-quality technical
materials for the scientific and medical
community and disseminate the critical
information regarding latest inventions,
discoveries and other significant medical updates
in the specialized field of medical science.
There is a vast difference between writing a
normal article for the general public and
developing scientific medical contents.
Scientific medical writing necessitates the
writer to deal with the development of
scientific and clinical documentation procedures
and present that critical information in a
standardized, authenticated, dependable and
credible manner. Planning and preparation of
Clinical Evaluation (CE) Report
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.
3- The scientific medical writer needs to have a
proper understanding of the various stages
involved in conducting a prior clinical
evaluation for developing technically-rich
Clinical Evaluation Report (CER). - MEDDEV (2.7/1) guidelines for CER documentation
- describe the various stages of planning,
assessment, and evaluation of clinical data
about medical a device to validate the clinical
safety and functional performance of the
concerned medical device. - Some of the important procedures and documents
involved in the CER development process include - Regulatory standards and guidelines
- Standard operating procedures for carrying out
Clinical Evaluation - Quality System related procedures and protocols
- Outlines for Clinical Evaluation Plan (CEP) and
Clinical Evaluation Report. - Pre-market and post-post market CER
- Clinical investigation data
- The scientific medical writer needs to conduct a
comprehensive literature review to search
appropriate literature concerning with the
specific device to identify relevant clinical
data. The scientific medical writing of medical
devices must also provide important details about
the mandatory European confirmatory CE marking
documentation, which provides the medical device
manufacturers declaration that the particular
device or product meets the specific
requirements and directives of concerned
authorities. - Language Rules for Scientific Medical Writing
- Scientific medical writers must have an in-depth
understanding of the various nuances involved in
medical writing and must follow important
standards in the preparation of superior quality
medical contents catering to the specific target
audience. - Absolute care must be given relating to
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.
4Thus, medical writing requires specialized
training and experience to gain comprehensive
subject knowledge and language usage skills to
develop complex scientific and medical contents
suitable for well-learned medical researchers
and healthcare professionals.
About Author, Dr. Nancy, Editor-in-chief, PEPGRA
Healthcare Pvt Ltd.
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.
5 2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.