Devinder Poonian

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clinical data management biostatistics site monitoring medical writing quality assurance prefda audits & gcp audits regulatory pharmacovigilance project management ctms research services clinical trial services cro clinical trial monitoring data management regulatory affairs therapeutic expertise infectious diseases dermatology oncology neurology ophthalmology critical care clinical studies phase i-iii trials safety monitoring patient safety data integrity cost-effective solutions high-quality services study execution trial management study design electronic data capture edc clinical trial success sponsor satisfaction site management medical device studies vaccines case report forms data validation tracking & reporting statistical analysis regulatory compliance risk management clinical research associates adaptive trial design fda compliance ind submissions biostatistical support quality metrics international studies productivity hospital & health care