Medical Writing for Regulatory writing for Clinical Documents

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MEDICAL WRITING FOR REGULATORY SUBMISSION
IN CLINICAL RESEARCH AND ITS CHALLENGES
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.
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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.
MEDICAL WRITING FOR Regulatory Submission in
Clinical Research 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, Investigators 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
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 guidelines and statutory requirements and
  also developing suitable document template that
  covers all current regulatory requirements.
• Investigators 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
  Investigators brochure include
• 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.

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.
4

• 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)
• Investigators 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.
• About Pepgra
• Pepgra is a quality-driven Contract Research
  Organisation (CRO) comprising advanced
  regulatory writers capable of delivering clinical
  study protocols and study reports in complete
  compliance with the ICH GCP guidelines. Pepgra
  offers complete assistance to the pharmaceutical
  and medical device companies

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.