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. Need for being concise with suitable presentation styles 2. Ascertaining the appropriate length of the document 3. Completeness and readability challenges 4. 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. Animal studies relating to safety and toxicology 2. Common Technical Document (CTD) 3. Stability studies 4. Development of full protocol and trial document formats 5. Good knowledge of regulatory requirements 6. 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. Clinical Development Plans (CSP) 2. Clinical Study Reports (CSR) 3. Documents relating to Investigational New Drug Applications (NDAs) 4. Investigator’s Brochures 5. Benefit and Risk Assessment reports 6. 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.