iCRAS Inc.
international Clinical
Research Auditing Services
We provide clinical auditing, inspection readiness, CAPA training and SOP services to support your clinical research program.
How We Can Help
Clinical Quality Assurance Services include:
GxP Audits
Domestic and International Clinical Research Study Audits – established audit program to ensure compliance with FDA 21CFR312 and 812, ISO14155, ICH E6 (R2) – International Congress on Harmonization Guidance, Japan J-GCP, China NMPA/NHC and other government regulatory authority regulations and guidelines. In addition, audit program is designed to ensure compliance to specific company Standard Operating Procedure (SOP) requirements.
Who We Are
iCRAS is an independent third-party service provider specializing in delivering a wide range of GxP auditing, Clinical Research and CAPA services proven to ensure our clients meet FDA and other global authority regulatory requirements. iCRAS partners with ex-FDA Auditors as well as with Certified Quality Auditors that have a minimum of 15 years of combined Clinical Research and Quality Assurance Field Auditing experience.