Chimera Clinical Management

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Chimera Clinical Management Services

Chimera Clinical Management and its parent company, Stram Clinical Services, have been in operation since 1995 and have offered a full range of cross-department research consulting services to biotech, pharmaceutical and device companies in the United States, Canada, Asia and Europe.

Chimera Clinical Management provides a broad range of services, including:

Global Project Management

  • Study management
  • Accelerated study start up and onboarding services
  • Large database of potential investigators
  • Clinical monitoring (including traditional, risk-based, and remote monitoring for safety and efficacy)
  • Protocol development and design
  • Foreign language vendor management and monitoring
  • Project finance support and tracking (vendor/site invoicing)
  • CRO and vendor oversight
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Quality Assurance

  • Regulatory document review and compliance services for sponsors and investigators
  • Quality system builds and SOP development
  • Training classes
  • CAPA planning and resolution
  • Quality assurance auditing (EU MDR and US FDA)
    • ICH-GCP internal, external, and vendor compliance
    • Laboratory compliance
    • Qualification
    • Site
    • TMF
    • Process
    • Internal

Regulatory Support

  • Regulatory affairs documentation and submission
  • Managing the creation and maintenance of 21 CFR-Part 11 compliant eTMF
  • Regulatory compliance and documentation
  • FDA submissions

CTA/Documentation

  • 21 CFR Part 11-compliant eTMF and document management
  • Multi-platform document management support, including Veeva
  • Study document design
  • Document receipt, review, filing, quality control, and archiving
  • Investigational product and study supply inventory and delivery management
  • SOP, work instruction, and policy generation and revision
  • Study plan writing and editing support
  • Study newsletter development