Clinical Trial Execution

• Feasibility Assesments
• Site and investigator selection
• Clinical Monitoring (Phase I-III, Late Phase)
• Project Management
• Interactive Response Technologies (IXRS)
• Patient Recruitment
• Site management
• Risk-based Monitoring
• Newsletter
• BE/BA Studies
• Audit/Compliance

Medical Writing

• Clinical study report
• Study protocols, amendments, and administrative changes
• Abstracts, Article
• Training material
• Poster

Data Management and Statistics

• Electronic case report form (eCRF) design, database design and study setup
• CRF Completion Guidelines
• Clinical coding with industry standards and client-specific dictionaries
• Reconciliation of safety and external data
• Data validation and query management
• Project management of data and technical services
• Data Management Plan (DMP), Statistical analysis plan (SAP) development
• Database Build & Design
• Data processing through double data entry
• Sample size calculation
• Randomization
• Statistical analysis and reporting