Nrupal Shah Email & Phone Number

Ahmedabad, Gujarat, India

Data review:- ( small & large molecules)*Providing bioanalytical inputs for all BA-BE clinical study protocol and clinical trials study protocol. * Checking & reviewing of electronic data generated in Method validation and study sample analysis.* Preparing & checking of bioanalytical study protocol. * Preparing & checking of bioanalytical study plan. * Preparing & checking of method validation plan. * Prepare an investigation report for bioanalytical anomaly observed during study conduct and its CAPA.* prepare an investigation report based on sponsor's concern for its study conduct in consultation with in charge / HOD. * Scientific review of method validation reports and bioanalytical report. * To respond sponsor queries. * Responsible for execution of training systems for BA function.* Providing feasibility of bioanalytical project to BD department.* Review of Method SOPs and BA SOPs.* Review SOP deviation, protocol deviation and investigation report.* Training.