• Quality Systems
• Regulatory Compliance
• Risk Management
• Sterilization
• Cleanrooms & Controlled Environments
• Clinical Services
• Biocompatibility
• Buy Training Modules
• Process Validation

Clinical Services

The following clinical services are offered by experienced clinical research personnel familiar with FDA, ICH GCP and ISO requirements:

• Literature Review
• Protocol Development
• Feasibility
• Clinical Site Identification and Selection
• Assistance with Case Report Form (CRF) design and review
• Feasibility studies prior to clinical trial implementation
• Clinical Project Management
• Biomedical Audits (BIMO) including:
  • Sponsors
  • Investigative Sites
  • Vendor