A full service Contract Research Organization

Offices in the San Francisco Bay Area and Sydney, Australia

Quality Assurance

At InClin Quality is not just assurance of internal process compliance, it is a service offering to our clients. At InClin, our quality assurance objectives are to help clients achieve regulatory inspection readiness and improve their own quality framework. These quality assurance objectives are accomplished through the following services:

INSPECTION READINESS

  • Compliance gap assessments
  • Issue review and preparation
  • Position papers
  • TMF filing and QC
  • Mock Inspections

QUALITY FRAMEWORK

  • Implementation of Quality Management Systems (QMSs)
    • Standard Operating Procedures (SOPs)
    • Training
    • CAPA development
  • SOP development