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Medical writing for regulatory submission .pdf



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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.
Regulatory submissions challenges in clinical trials
Regulatory Writing and Publishing poses many challenges for the medical writers in the writing
and development of critical documents like Clinical Study Report, Investigator’s Brochure, and
clinical trial protocol development and in the preparation of documents for FDA meetings and
briefings.
The Clinical Study Report (CSR) is a critical document that provides an integrated report
comprising the clinical and statistical description of the investigational study of therapeutic or
prophylactic drugs in a single report with relevant tables, figures, and appendices. A medical
writer will face challenges in understanding the guidelines and statutory requirements and also
developing suitable document template that covers all current regulatory requirements.
Investigator’s Brochure is an essential regulatory document that provides an overview of the
clinical and non-clinical findings of the trial study and is primarily used as an investigator guide to
assessing the risks and benefits of the product under investigation. The major challenge
commonly faced by the regulatory medical writer in the preparation of Investigator’s brochure
include

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
Medical Writing Experts™ -A Unit of Guires Solutions Pvt Ltd.
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@medicalwritingexperts.com, Web:www.medicalwritingexperts.com.



Need for being concise with suitable presentation styles.



Ascertaining the appropriate length of the document



Completeness and readability challenges



Time management

Preparing briefing documents for FDA meetings is another major challenge faced by the
regulatory medical writers as it involves extensive writing relating to new products description,
clinical pharmacology, mechanism of action, pharmacokinetics, clinical review on its efficacy,
safety, Benefit-Risk summary, and assessment.
Clinical Trial Protocol Development is a complicated process that involves proper planning and
diverse document requirements during the pre-clinical and clinical stage as specified by the
regulatory authority, which includes


Animal studies relating to safety and toxicology



Common Technical Document (CTD)



Stability studies



Development of full protocol and trial document formats



Good knowledge of regulatory requirements



Obtaining informed consents from the participants of the study

Regulatory medical writers need to have an adequate understanding of the important activities
involved in Clinical Trials and Good Clinical Practice, which may present them challenges like
large time requirements to develop high-quality medical contents specific to the target
audience.
Also, Pre-clinical and scientific reports pose challenges to the regulatory medical writers as
these reports need to have accurate facts, statistical data, relevant tables, and figures.

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
Medical Writing Experts™ -A Unit of Guires Solutions Pvt Ltd.
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@medicalwritingexperts.com, Web:www.medicalwritingexperts.com.

Comprehensive Regulatory Writing Services
International regulatory writing firms can offer immense assistance to the companies
conducting clinical research trials by helping them in the writing, editing, organising and the
compilation of broad range of essential medical and scientific documentation like


Clinical Development Plans (CSP)



Clinical Study Reports (CSR)



Documents relating to Investigational New Drug Applications (NDAs)



Investigator’s Brochures



Benefit and Risk Assessment reports



FDA meeting documents and briefings

Thus, it is advisable for the healthcare, pharmaceutical, biotechnology, medical device, CROs
companies to entrust these complex regulatory works to a global regulatory writing services
team of experts, to meet the various challenges like stringent regulatory body requirements,
multiple agencies approval prerequisites and timely submission of essential documents.

© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
Medical Writing Experts™ -A Unit of Guires Solutions Pvt Ltd.
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@medicalwritingexperts.com, Web:www.medicalwritingexperts.com.


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