Protocol design and development, including support for meetings and conference calls |
Preparation of applications to central regulatory authorities and central ethics authorities, as applicable |
Collection/monitoring of institutional and investigator regulatory compliance |
Verification of patient eligibility and management of treatment assignment |
Clinical trial insurance |
Patient random assignment |
Database development |
Data collection and management |
Drug supply and distribution |
Statistical design and analysis |
Tumor, specimen and imaging banking |
Quality assurance/quality control |
Onsite monitoring and audits of participating sites |
Pharmacovigilance |