How Regulatory Writing Plays an Essential Role in Clinical Research - Pepgra

1.   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.

2. 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.

3. the 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,         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.              guidelines and statutory requirements and also developing suitable                                                                                                       mechanism     of     action,                                                                                   © 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.

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    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,       prerequisites and timely submission of essential documents.      About ​Pepgra                                                                                  multiple   agencies   approval 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.