Clinical Operations

The breadth of our experience allows us to provide a wide variety of consulting expertise on an as-needed or ongoing basis.

These services include:

• Clinical Research Business Planning
  
  
• Project resourcing
  
  
• Clinical trial cost estimates and payment forecasting
  
  
• Outsourcing strategy
  
  
• Proposal and vendor selection process
  
  
• Vendor contract management
  
  
• Clinical Operations
  
  
• Protocol design
  
  
• Project Management
  
  
• Vendor Selection - Regulatory, Data Management, Clinical Monitoring, Biostatistics, Safety, etc.

• Quality Systems evaluation and enhancement
  
  
• Quality Assurance Audits
  
  
• Clinical trial services (CRO, IT vendors) - vendor qualification and performance audits
  
  
• Clinical site audits
  

• Training
  
  
• Clinical Safety Surveillance
  
  
• Data Monitoring Committees
  
  
• Biostatistics
  
  
• Clinical Site Monitoring
  
  
• Investigator Responsibilities
  
  
• Medical Device development
  
  
• Pharmaceutical development