Clinical Research

Pharmacovigilance and Drug Safety Expertise

Regulatory Affairs

 

Clinical Research

Patient Recruitment: Forecasting, Monitoring and Managing Clinical Technology: CTMS, EDC, ePRO, Oracle Clinical, Rave, Inform (Need to check if we can have resources taking sessions on Rave and Inform) Therapeutic Expertise TAs that can be covered like Musculoskeletal, Oncology, Infectious Diseases, Women’s Health, Respiratory.

Study Start Up Study design Finalization of Protocol Selection of CRFs Vendor selection Activities for studies that are planned to be outsourced

Study Maintenance Discrepancy Management Query Management Discrepancy Management SAE Reconciliation Lab data reconciliation Clean Patient Checks

Study Finalization Follow-up and resolution of discrepancies SDV to account for information collected Completion of CRFs Accounting/Reconciliation for samples collected Data Archival Coordination with other line functions during statistical analysis or CSR writing.

Monitoring Activities Source Documentation Verification Site Monitoring Visits Investigators Training Training site staff on usage of tools

   
   

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