Courante Oncology
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services


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
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©2017 Courante Oncology  |  952.908.9986  |  email us
  • Home
  • About
    • Client Benefits
  • Services
    • Specialty Projects
  • Experience
  • Contact