Harshad Rasane

Background

About Harshad Rasane

Post graduate in Health Science with experience in the Clinical Research domain •Indepth understanding of all study protocols due to medical qualification •Experience in medical writing o ICD o Protocol synopsis o Clinical Trial Protocol o IB o Module 2.5, 2.7 & 5 • Co-ordinate and contribute for preparing follow up as well as final CSR • Experience in various therapeutic domains viz, Oncology, Rheumatology, Respiratory, Cardiology, Osteology and Opthalmology • Experience in Phase and BE trials for USFDA submission • Experience in reviewing and providing inputs on TLGs, CRF, Source documents, study specific logs and forms and other study related documents • Experience in preparation, review and release of essential documents for clinical trial submissions and publications • Experience in searching and extracting relevant literature from medical journals and databases • Experience in responding to Regulatory queries • Experience in case based evaluation of adverse events and serious adverse events and ensure timely reporting of SAE as per regulatory requirements • Experience in conducting training sessions for Internal team as well as site team on ICH-GCP, Regulatory guideline updates, study protocol and topics relevant to clinical research • Experience in concise summarization of various preclinical as well as clinical studies • Experience in reviewing various clinical trials as an IEC member • Experience in reviewing manuscripts as a Reviewer • Experience in protocol registration at CTRI and responding to related queries • Coordination with internal (Operations, DM, PV, Regulatory, QA, CTSM) as well as external stakeholders (Sponsor, CRO, PI, DSMB) • In depth understanding of the clinical research processes, responsibilities, accountabilities and deliverables • Experience in teaching Ayurveda (its fundamentals & pharmacy) to M. Pharm students. • Excellent biomedical communication and writing skills