Quality

Quality management and quality assurance is regarded with high priority at XClinical. XClinical works according to GCP guidelines. Our quality management is based on a planned ISO9001 certification. Our system MARVIN complies with all relevant FDA regulations and with 21 CFR 11. We invite you to perform an external audit of our system validation procedures. A number of such audits has already been completed successfully.

XClinical’s planned admission to a program called “registered CDISC solution providers (RCSP)” is proof of the quality of our products and services. This program is an official qualification by system integrators and subject matter experts with profound experience in the introduction and implementation of (the various) CDISC standards. CDISC established this program as a service for organizations who are looking for assistance implementing CDISC standards.