360CQA has a growing team of full-time. employed permanent consultants, each with an average QA experience of over 10 years. Our highly experienced, trained, and competent team of GCP auditors has conducted more than 2000 audits in all therapeutic areas,
according to international and China regulations, for 600 sites in over 12 countries, including 500 sites based in China.
The conduct of GCP audits is becoming an increasingly challenging process, owing to the complexity of clinical trials and the location of investigator sites. Though many sponsors reside in Europe, the USA, and other
regions, their investigational sites are often in China. Auditors are challenged with physically reaching the investigator sites, yet they also have to deal with the diverse cultures they encounter. 360CQA has a global view
and China-based experienced staff. Not only does this help with language and cultural barriers, but also the travel time and cost for the conduct of these audits.
OUR RANGE OF GCP SERVICES INCLUDES:
INVESTIGATOR SITE AUDITS:
Routine Investigator Site Audits (Phase I to IV)
For Cause Investigator Site Audits (Phases I to IV)
SYSTEM AUDITS:
System Audits of Sponsors/CROs
MOCK INSPECTIONS:
Inspection Preparation and Training (Investigator Site/Sponsor/CRO)
Mock Inspections
Inspection Facilitation
DATA MANAGEMENT：
Database Audits
Data Management system Audits
Data management processes audit
TRIAL MASTER FILE (TMF)：
TMF Audits
DOCUMENT AUDITS：
Protocol Audits (all Phases)
Case Report Forms
Informed Consent Forms
Investigator Brochures
Clinical Study Reports
Development Safety Update Reports
VENDOR AUDITS：
Monitoring and Project Management
Data Management, Biostatistics, and Medical Writing
Clinical Trial Supply
Interactive Response Technology
Centralized ECG/Imaging Facilities/Pathology
CONSULTANCY SERVICES:
SOP Development
QMS Evaluation