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

PRIMARY SERVICES

Quality Auditing – Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) audits to include:

• Sponsor Audits
• Clinical Site Audits
• Vendor/Contractor Audits
• Compliance/documentation systems Audits
• For cause investigations
• Pre-qualification Audits
• Electronic systems and software manufacturer Audits

QA Infrastructure Development

Training – in support of GCP and clinical laboratory activities

Clinical Laboratory Accreditation Services – we specialized in domestic (US) and international College of American Pathologist (CAP) accreditation.

Prequalification audits and Preparation Service – review quality systems in lieu of regulatory and/or notified body inspections/audits (e.g., US FDA).

SECONDARY SERVICES

Good Manufacturing Practice (GMP)

• Quality auditing
• Training
• Infrastructure development

Regulatory Affairs – regulatory document review, preparations and submissions