Sanjan Ashala

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cro biostatistics & statistical programming clinical data management medical writing regulatory services pharmacovigilance biotechnology research biostatistics statistical programming regulatory affairs clinical trials data analysis statistical reports protocol development study design power calculations sas programming cdisc standards data integrity therapeutic areas quality assurance regulatory compliance drug development clinical research adaptive trial designs bayesian methodologies risk management clinical study reports safety reports database design data migration ecrf design data validation signal detection health authority reporting auditing services drug approvals marketing authorization investigational new drug applications periodic safety reports pharma industry biotechnology support data management plan medical coding real-world evidence submissions management regulatory strategy clinical trial applications post-marketing surveillance integrated summaries of efficacy & safety risk minimization activities health care health wellness & fitness hospital & health care data analytics