Jeevan Yewale
Team Lead
Medical
Cipla
India
Biography
• Clinical Research Professional with 10 years of experience in management of global clinical trials • Expertise in handling Phase I to Phase III trials and BABE studies • Proficient in developing clinical strategy / clinical development plan for respiratory products • International exposure for conducting clinical trials in India, USA, Europe, New Zealand, Canada, South Africa, Thailand, Israel and Uganda for various regulatory submissions (FDA, EU, TGA, Health Canada, ANVISA) • Therapeutic area experience in Respiratory, Osteoarthritis, Anti-Infective, Oncology and Ophthalmology • Expertise in Medical Writing: Protocol, Clinical Study Report, Clinical & Non-Clinical Summary, Regulatory Query Responses, ICF, CRF, Patient Diary • Comprehensive understanding of Clinical research Practices and Global Regulatory Guidelines • Possess excellent inter-personal and organizational skills with proven abilities in team management, process enhancement and training & development
Research Interest
clinical strategy / clinical development plan for respiratory products
