Our unique staff has over 50 years of combined clinical research experience and our team is growing! We’ve worked with some of our sites for 20+ years and have developed strong relationships that aid in your product success and push through FDA, CE marking, and IRB approvals.

 

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 Usability

  • Onsite IVD/life science device Usability Lab
  • User needs identification
  • Usability plan development
  • User profile generation
  • Conceptual usability study planning & execution
  • Formative usability study planning & execution
  • Summative usability study planning & execution
  • Coordination & Submission to FDA/IRB
  • User centered design & development

Complete Study Management

  • Protocol, CRF, Source Development, ICF, and training material design & development
  • Site selection/contract negotiation/qualification
  • IRB/ethics committee review and approval
  • Clinical trial supplies and logistics/supply management
  • Site initiation/investigator meetings
  • Site monitoring
  • Data management
  • Site closeouts
  • Report writing

Regulatory Affairs, QA & Compliance

  • Federal, State & Local Regulations, Registrations & Licenses
  • FDA 510(k) & Foreign Regulatory Approvals
  • Device Listings
  • Establishment Registrations
  • U.S. Agent for Foreign Companies
  • Pre-Clinical Biomechanical Testing
  • FDA Inspections & Audits
  • Recalls & Field Corrections Procedures
  • FDA QSR
  • ISO 13485
  • Quality Manual, SOPs, WIs
  • S. & Foreign Supplier Quality Audits
  • FDA MDR Reporting
  • Corporate Compliance Program Development
  • Compliance Training
  • HIPPA Requirements
  • Compliance Program Audits