Clinical Trial Designer
Introducing Clinical Trial Designer Arijit Sil, a board-certified physician specializing in Clinical Pharmacology and a pivotal partner for pharmaceutical companies aiming to bring innovative therapies to market.
With expertise in designing robust clinical trials, he streamline the research process, ensuring regulatory compliance and optimal study outcomes. His commitment to excellence and patient safety drives project, helps in navigating the complexities of clinical development with confidence.
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About Arijit Sil
Clinical Trial Expertise
Arijit Sil is a board-certified physician & Clinical Pharmacologist with 16 years of experience in clinical development, medical affairs and 3 years in academic as Assistant Professor in MKCG medical college. I have helped organizations by defining strategic clinical development plan for 3 vaccine projects (enrolled 300 to 500 subjects each and span over 14 to 18 months) in line with global R&D strategy.
I have also overseen the medical safety of 10 national as well as multi-national Clinical trials (enrolled 5000 subjects approximately), ensuring compliance with current regulation, respecting timeline budget and quality.
Experience
Professional Achievements
IQVIA RDS (INDIA) PVT LTD.
INTERNATIONAL VACCINE INSTITUTE, Seoul, South Korea
SANOFI HEALTHCARE (INDIA) PVT. LTD, Hyderabad, India
Associate Medical Director
Provided medical expertise to 6 streams of clinical trial such as Vaccines and Infectious disease etc.
Research Scientist
Completed Phase-2 study and initiated Phase-3 licensure study for Vi-DT Typhoid vaccine
Assistant General Manager
Procured marketing license from DCGI and pre-qualification from WHO for Shan5 (Paediatric Combo Vaccine) following Phase-3 result submission which allow both marketing in India and stock piling for UNICEF and GAVI
Panacea Biotec Pvt Ltd. Mumbai India
Macleods Pharmaceutical Ltd. Mumbai
MKCG Medical College, Berhampur
Manager-Strategic Medical Affairs
Provided scientific, medical, and educational resources and training as necessary
Deputy Manager -Medical Services
Prepare disease and product training materials for marketing and sales team.
Assistant Professor in Pharmacology
Taking classes of Medical, Pharmacy and Nursing students both Theory and practical, which clear the concept and secure better result.
Education
Academic Background
MD in Clinical Pharmacology
Residency Training - Board Certification
MBBS, Bachelor degree in Medicine and Surgery
Medical Conferences - Professional Development
Publication
Advisory Board meeting &White paper
Respiratory Field- Involving 6 Pulmonary and Chest Physicians
Title: Landscape of Clinical Trials in asthma and COPD in India
Vi-DT Typhoid Phase II Publication
EClinical Medicine; 2020 Sep 9; 27:100540
Safety and immunogenicity of Vi-DT conjugate vaccine among 6-23-month-old children: Phase II, randomized, dose-scheduling, observer-blind Study
Cholera vaccine (Cholvax) Study
Title: A non-inferiority trial comparing two killed, whole cell, oral cholera vaccines (Cholvax vs. Shanchol) in Dhaka, Bangladesh.
Typhoid Vaccine Study from PT Biofarma Indonesia
International Journal of Infectious Diseases, 2020; Vol. 93, p102-107
Title; One-month follow up of a randomized clinical trial-phase II study in 6-<24months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine
Vi-DT typhoid Phasee II study-SK Biopharma
Title: Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report.
Shan5 Licensure Phase III study in Sanofi
Human Vaccine and Immunotherapeutics,
2016; Vol.12, No. 4; p946-954
Title: Safety, immune lot-to-lot consistency andnon-inferiority of a fully liquid pentavalent DTwP-HepB-Hib vaccine in Healthy Indian Toddlers and Infants
