services

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We offer a wide range of clinical trial management and support services to the pharmaceutical and medical device industries, including project management, clinical site monitoring, quality assurance, and medical writing services.

Consulting

• Product evaluation and strategy
• Organization of external consultant meetings
• Regulatory submissions to FDA and IRBs

Study Start-up

• Protocol development
  
• Feasibility studies
• Identification and recruitment of qualified study sites and investigators
• Review and negotiation of study budgets and research agreements
• Regulatory document collection and tracking

Monitoring

• Clinical site monitoring and data collection
  
• Good Clinical Practice site compliance
  

Data Management

• Case report form design
  
• Database creation and validation
• Adverse event and medication coding

Project Management

• Customized tracking of patient and site status
  
• Investigator meetings

Statistical Analysis

• Organization and oversight of Data Safety Monitoring Boards
  
• SAP generation and execution
  

Medical Writing

• Medical writing of protocols, regulatory applications, study reports, and publications
  

Report Submissions

• Investigational New Drug submissions
  
• Institutional Review Board submissions and regulatory document tracking
  

Quality Assurance

• Clinical site audits
  
• Database, report and file audits
  

Specialty Projects

At Courante Oncology, we can also provide experienced, well-trained clinical trial resources to help ease your short-term work crunch and meet impending deadlines. And without any long-term commitments or contracts!

specialty projects