Harshada K.

Myself Harshada Khude , completed M. Pharm with distinction from Mumbai University, GPAT qualified in 2020, Currently I am working as QA for clinical trial at Clinexel. Providing training to newly join corporate workers on GCP, GDP and GWP. Currently learning lean six sigma certified coach program. Worked as QC clinical medical writing. preparation and review of informed consent form and case report form used in clinical research. Preparation of BE NOC documents and ethics committee files ( files submitted to ethics committee for approval before study is conducted). Checking of all the files after EC approval. Worked as CRA review the documents related to clinical trials. Having good knowledge about ,case report form, information consent form , patient daily diary card, SMF, TMF and protocol, phase IV clinical trial. Having knowledge and experience of PSUR and RMP aggregate report preparation for domestic and export, review of PSUR and RMP. Narratives preparation and review and ADR handling. Handled phase II, IV and III trials. Good knowledge and experience of preparation of interim and final case study report. active PMS report preparation and review. SOP preparation. having good knowledge and experience in documentation good knowledge about IPQC and IPQA.Having 6 months of experience as trainee in Formulation Research and Development department at Umedica laboratories R and D Center, Turbhe. Knowledge and experience of handling tablet manufacturing machinary i.e. granulation, compression and coating machines. Main author for 2 research article published in ugc approved journal with impact factor 7.94 and co author of 3 research articles.