Quality Assurance

 

Clinical Consulting  quality assurance staff provides:

 

• In house Audits System for monitoring procedures

• On site audits, routine and on demand

• Compliance Management

• Site preparation to inspections

• Trainings for company and site staff for FDA inspection

• Trainings for CRAs / CTAs

• Independent translators during FDA and EMEA inspection

• Consultancy on SOPs writing

 

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s). (ICH GCP Guideline, Section 1.46).