Quality and references

Quality

dinox has high quality standards, which have been confirmed by many audits and inspections.

 

Quality references

All trials are conducted in compliance with ICH-GCP and applicable laws and regulations. All trial staff members are trained in ICH-GCP and work in accordance with dinox SOPs. This includes completing training on clinical and laboratory procedures, use of technical equipment and carrying out emergency procedures. The clinical team is trained in the correct completion of ISFs, source documents and (e)CRFs as well as in the handling of investigational products and drug accountability.

Over the years, many study, system, and facility audits have been conducted at dinox by well-known pharmaceutical companies. Inspections have been carried out by Dutch, German and American authorities (FDA). These audits and inspections have always confirmed the high quality standards of dinox.

 

Quality Manual and Brochure / Accreditation

In November 2014 dinox GmbH has been granted the dqs/dakks accreditation (DIN ISO 9001), which confirms our high quality claims.

A summary of our quality brochure can be forwarded upon request.