With regulatory inspections on the rise, you need to be sure your sites adhere to the most stringent requirements for compliance and patient protection. Our rigorous auditing process is designed to identify and address issues before the Authorities do and prepare your team to answer questions with confidence.
Our company performs audits for all trial related processes and functions since 1993. SSS International Clinical Research devotes special attention to compliance with GCP requirements and to quality of obtained data. Our company has implemented and been following the international standard ISO 9001:2008 for Quality Management (QM).
Independent auditing can point out problem areas, reduce future costs, streamline project schedules, and ensure regulatory compliance.
On-site audit of trial site
Audit of Study Protocol
Audit of trial database
Audit of computerized data systems