Clinical Investigator Support and Site Management


  • Expertise in IDE, Biologics, IND, and Outcome Studies

  • Study Management
    • Adherence to Good Clinical Practice
    • Site Qualification
    • Site Monitoring
    • Protocol Development/Study Design
    • Adverse Events and Safety Monitoring
    • Institutional Review Board Process
    • Maintaining Effective Communications with Sponsors and/or CROs, IRBs, and the Institution
    • Study Closure

  • Data Analysis

  • Financial Services
    • Clinical Trial Contract/Agreement Negotiation
    • Healthcare Reimbursement
    • Study Compensation

  • Peer Reviewed Publications

  • Study Coordination
    • Subject Enrollment
    • Subject Recruitment
    • Adverse Event Reporting
    • Subject Compensation Management
    • Subject Retention
    • Institutional Review Board Process Management
    • Patient Compliance
    • Data Collection

  • Database Management
    • Data Collection
      • Patient Reported Outcomes
      • On-site Paper-Based and/or Electronic Data Capture
      • Off-Site Data Capture via Patient Web Portal or Mailed Outcome Forms
    • Real-Time Quality Control


SPIRITT TM RESEARCH

12977 North Forty Drive, Suite 200 - St. Louis, MO 63141 USA
Phone 314-738-8026 | FAX 314-548-6221 | jdaegele@spirittresearch.com

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