The study quality is crucial for the success of any clinical research. The increasing clinical trial activities in China call for ever-increasing emphasis on compliance with Good Clinical Practice (GCP) in order to safeguard the rights of human participants and to protect the integrity and validity of clinical research data. Pharma-engine’s experienced clinical quality assurance professionals can help you conduct in-depth audits of your systems, your investigators sites and your documents/reports to ensure that your system and on-going projects are GCP-compliant.

From individual site audits or system audits to multi-site quality assurance audit programs, FDA or SFDA Mock inspection designs and delivers the QA services you need to meet China, USA, Europe and Japan’s increasingly stringent requirements.

Pharma-engine’s Quality Assurance services:

• GCP Compliance Audits
• System Validation Audits
• Mock China SFDA and USA FDA Inspection s (Complete range of clinical auditing capabilities)