SPARC Consulting has established Standard Operating Procedures (SOPs) in accordance with ICH guidelines and other regulatory requirements which are regularly updated to reflect regulatory environment and changes in technology.

Our electronic records and clinical database are all 21 CFR Part 11 – FDA compliant.

The firm works according to the Italian Law Degree dated on 15 November 2011 (CRO Degree).

In December 2015 the company was audited by AIFA in order to verify the adherence of the company to the minimum requirements foreseen by the CRO degree and to assess the Quality System implemented by SPARC Consulting.