• Clinical Trials Planning and Execution

• Clinical Data Management

• Information Systems Development

  • For regulated systems (21CFR11)

  • For unregulated systems

• Document Management Processes

  • Regulated documents

  • Un-regulated documents

• Laboratory Data Management

• Issues and Complaint Management and Reporting

• CAPA

• Data Capture

  • Paper based double data entry

  • Remote Electronic Data Capture

  • Central and Remote Imaging

• Meta-Data Management

• Medical and Drug Dictionary Management

• Data Standards Management

• Quality Management

  • Quality Control

  • Quality Assurance

• Program and Project Management

• Inventory Management

• Trial Supply Management

• Device Manufacturing

• Device Installation and Maintenance

• Payroll Processing

• Prospect Qualification and Scoping

• Product Design and Development

• Safety Monitoring and Reporting

• Performance Management

• Budget management and control for clinical project portfolio

• Investigator Site Selection and Management

• Regulatory Reporting

• Product Labeling

• Materials Handling Management

• Supplier Selection and Management

• Software Development and Deployment in regulated environments

• Distribution and After Sales Service

Conducted process compliance reviews and formal audits