CLINIQAL ^TM, Inc. holds comprehensive commercial liability insurance for the protection of our clients!

PRIMARY SERVICES

Quality Auditing – Drugs, Biologics and Medical Device Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) audits to include:

• Investigator Site Audits
• Vendor Qualification Audits (e.g., Full Service CROs, Clinical/Medical Laboratory, Electronic Systems, Drug Depots)
• Electronic Systems Validation and Medical Software Manufacturer Audits
• Inspection Readiness Audits (e.g., US FDA, MHRA, EMA, PMDA)
• Sponsor Audits
• For Cause/Directed Investigations
• CAPA follow-up and Effectiveness Verification

Training

• Clinical Quality Assurance Training
• Auditor Training
• GCP Training (Drugs, Biologics and Medical Device)
• Clinical/Medical Laboratory Standards Training

Clinical/Medical Laboratory Accreditation Services

• Expert Consulting and Infrastructure development in support of ISO15189 and international College of American Pathologist (CAP) accreditations, and US CLIA (42 CFR 493) licensure.

SECONDARY SERVICES

Medical Device Good Manufacturing Practice (GMP)

• Quality auditing
• Training
• Infrastructure development

Regulatory Affairs – regulatory document review, preparations and submissions