Nissi Noorbasha
Research Associate @Axis Clinicals Ltd
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WORK HISTORY
Research Associate @Axis Clinicals Ltd
EDUCATION
Geethanjali College of Engineering and Technology
Doctor of Pharmacy, Pharmacy Pharmaceutical Sciences and Administration
ABOUT NISSI NOORBASHA
Having an experience in Synopsis, Protocol, ICD\'s, CRF\'s & eCTD modules and Summary reports writing, reviewing and editing, literature searches though several search database.perform literature searches to obtain investigator\'s brochure, PAR\'S, articles, biopharmaceutical reviews, for development of bioavailability/bioequivalence study synopsis and study protocols.Drafted, edited and submitted clinical study protocols, protocol associated appendices and ammendments as per the sponsor requirements and regulatory guidelines.prepared documents in accordance with sponsor\'s standard operating procedures and specifications as applicable and relevant ICH and regulatory guidelines.Experienced in preparation of study protocols with different study designs, dosage forms and regulatory.sample size calculations.Experienced in preparation of informed consent documents.involved in regular interaction with the investigators of various departments for protocol inputs and regarding patient safety concerns.providing responses to the sponsor\'s regulatory and DCGI queries.Iam always eager to learn new skills, expand my knowledge, and take on the new challenges in the field of my pharmaceutical sciences.
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