Support Services

Support Services

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  • Compliance Assessments   
    Comprehensive FDA and Sponsor compliance review including GAP analysis and recommendations
  • Clinical Research Operational and Organizational Developmental Plan build and implementation   
    Development and implementation of a formal operational and organizational Development Plan to insure optimal compliance, personnel, IT systems, governance and sponsor outreach and engagement
  • Infrastructure (non-clinical)Development  
    Operational and Systems support to non-clinical functions such as Finance, Legal and Business Development and Operations
  • Compliance and System's Training  
    Conduct of regulatory, quality and functional training
  • Site Management  
    Oversite and management of all aspects of study conduct
  • Study Proposals & Contracting  
    Development of electronic study budget tools, sponsor negotiations and study contracting
  • Administrative & Staffing support  
    Fractional staffing of highly experienced study personnel
  • EMR analytics  
    Development of EMR mining tools for patient requirement
  • IT Systems build, Development and management  
    Identification, installation and maintenance of study management systems
  • Business Development (grant and industry)  
    Sponsor and funding outreach, Marketing, Branding and Communications