HOW WE CAN HELP

SERVICES

 CLINICAL AND REGULATORY AFFAIRS

  • Clinical Development Plans
  • Program Management
  • Regulatory Strategy
  • F2F Negotiations and Written Communications with the FDA, Health Canada, and Competent Authorities (de Novo, 510k, IDE, HDE, IND)
  • Sponsor-Representative IND Regulatory Agent
  • Trial Planning, Efficiency, and Operations
  • Quality Assurance and Audits
  • Patient Recruitment and Enrollment Rates
  • Patient Input
  • Realistic Costs and Timetable Projections
  • Resourcing Decisions and Recruitment
  • Job Descriptions and Organizational Policies and Manuals
  • Team Training on Regulatory and ICH-GCP topics

 COMPLIANCE AND GOVERNANCE

  • Executive-level Corporate Start-up and Corporate Operations
  • Trial Master File (TMF) Quality Assurance Audit and Management
  • Inspection-Readiness
  • Corporate and Ethics Policies
  • Fair Market Value Analysis
  • Risk Assessment and Mitigation
  • Gap Analysis
  • Clinical Research SOPs
  • Contract Management
  • HR Functions and On-boarding Programs
  • KOL, Scientific, Medical Advisory Board Contracting and Management
  • Committee Charters

 CRO/VENDOR DUE DILIGENCE, SELECTION, MANAGEMENT

  • RFP Generation for Clinical Trial Programs
  • CRO and Third-Party Selection, Contracting, and Management
  • Bid Defenses
  • Sponsor-Representative for CRO/Vendor Oversight per 21 CFR and ICH GCP
  • Sponsor-CRO Match Program

 POLICY AND INNOVATION

  • EHR-to-EDC Interoperability
  • E-Technology, Patient-Reported Outcomes (PRO), and Wearables
  • Blockchain, AI, IoMT: Impact on Life Sciences and Regulatory Policy

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