global provider of customized laboratory and research services

Consultation Services

Mount Sinai Services integrates deep scientific and clinical expertise with industry leading technologies resulting in a proven flexible approach to streamline the development process.

Clinical Program Support

  • Project feasibility assessment
  • Clinical and Non-clinical Project Requirements
  • Quality Management
  • Project coordination with academia and industry (including compliance with FDA)
  • Pre-IDE Development, Regulatory Strategy, and Predicate Determination
  • Health Technology Assessment
  • FDA Interactions, Submission Assembly and Follow-up
  • Report of Prior Investigations
  • Protocol Development
  • Reimbursement Strategies
  • Post-Market Support
  • Device Specific SOP Development
  • Safety Reporting

Data Management

  • Statistical Analysis Plans
  • Statistical Project Management and Support
  • Statistical Analysis, Reports and Tables
  • Data Management Plans
  • Data Project Management and Support
  • Data Collection Tools (Worksheets, CRF, eCRF)
  • Database Development, Validation and Management