Quality Assurance

Compliance with FDA and international regulations, as well as internal Sponsor SOPs and work practices is essential in clinical development.  We focus on accuracy and integrity through a keen emphasis on quality assurance and quality control.


GCP Support Services:

Training

  • GCP for sites, sponsors and study staff

  • FDA audit/inspection preparation

  • FDA Form 483 and warning letter response

  • Quality system requirements for research sites

QA Auditing

  • Vendor Qualifications and Audits

  • Routine Site Audits

  • For Cause Site Audits

Remediation

  • Preparing for FDA audit/inspection

  • Responding to 483s and warning letters

  • Finish outstanding site activities - site focus

  • Finish study closure activities - sponsor focus