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.
Email:info@pepgra.com, Web:www.Pepgra.com.
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, 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
© 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.
Email:info@pepgra.com, Web:www.Pepgra.com.
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
1.
2.
3.
4.
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
1.
2.
3.
4.
5.
6.
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
PEPGRA Healthcare Pvt Ltd
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@pepgra.com, Web:www.Pepgra.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
1.
2.
3.
4.
5.
6.
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.
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.
Email:info@pepgra.com, Web:www.Pepgra.com.