Keyur Parikh

Dr Hetal Shah is a PhD Pharmacologist with over 17 years of first-hand experience in the field of clinical research and medical writing. She is an Independent Clinical Research Professional based at Ahmedabad India. She is also the Founder of MeWriT® Healthcare Consulting – an independent medical writing and training consultancy service. Gold medalist for her manifold academic achievements, Dr Shah also has several publications to her credit including book chapters, research papers and review articles in national as well as international journals. As an independent consultant with high standards for quality and work ethics, Dr Shah is involved in manifold clinical research services as pharmacological/clinical expert. She is also extensively in developing integral regulatory documentation & publications for pharmaceuticals & research organizations. As a trained clinical research professional, she is well-versed with various national and international regulations governing clinical trials and good clinical practice. Dr Shah has a rare combination of first-hand experience in handling varied clinical studies, both, at investigative sites as well as CROs. She has in-depth knowledge of GCP and its implementation, clinical trial operations, trial monitoring as well as overall clinical project management. She serves as a Pharmacologist and Clinical Expert for various areas of clinical study design and protocol development, study reporting and regulatory responses. As an independent medical writing expert, she takes full accountability for first-hand writing, editing and finalizing of submission-ready documents for various therapeutic areas. Her writing sphere currently ranges from preparation of clinical trial documents to clinical study reports; compilation of drug authorization dossiers to scientific publications for journals. Dr Shah is also an experienced trainer with practical approach to coaching, and independently conducts medical writing & Clinical Research workshops and trainings customized for various topics and audiences’ needs. She is a member of the International Society of Medical Publication Professionals (ISMPP), Indian Society of Clinical Research (ISCR), executive committee of All India Medical Writers Association (AIMWA) and an ex-member of the DIA Medical Writing group of India. An accomplished professional herself, she effectively collaborates with therapeutic area experts, bio-statisticians, auditors, QA personnel, as well as in-house and allied clinical research teams to ensure a complete, accurate, cost-effective, and timely solution for your clinical projects or writing needs, with the best of quality and ethics. Dr. Shah has been felicitated as ‘Woman Entrepreneur in Pharma & Healthcare’ by the AIC-LMCP foundation (supported by Atal Innovation Mission, Government of India) at Ahmedabad, on 12 January 2019. Dr. Shah has received the ‘Hall of Fame’ Award from the Indian Society of Clinical Research (ISCR) in Mar 2021 for her contributions to the Medical Writing Council activities.