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Clinical Development
Clinical Development Plan (CDP)Clinical Study Design Clinical Study Protocol Synopsis Clinical Study ProtocolMedical Monitoring/Safety MonitoringClinical Study Data Review Patient Profile Review Medical Code Review Protocol Deviation Review



Pharmacovigilance
SAE and AE Case ReviewDrug Safety Signal DetectionDrug Safety Risk Management Plan (RMP)Development Safety Update Report (DSUR)Periodic Benefit - Risk Evaluation Report (PBRER)
Medical Writing
Clinical Study Protocol Synopsis Clinial Study ProtocolInvestigator Brochure (IB)Clinical Study Report (CSR) NDA/BLA Sumission Documents