Quality Assurance

The Context

We perform audits at all stages and on all processes used in the management of clinical trials and health related studies to assess adherence and compliance with SOPs, GCP, regulatory requirements, study protocols, client instructions and contractual obligations.

Our Services Include the following types of audit

- Investigational site facilities
- Study data
- Trial master files and investigator site files
- Monitoring compliance
- Clinical trial documents including clinical trial reports
We can also provide the following ad-hoc services:
- Review of current structure and policies, processes and documentation
- Identification of corrective and preventive actions for process improvement
- Implementation of a comprehensive and efficient system enabling a consistent quality structure
- Writing, reviewing or updating SOPs

Our Solutions

Early Stage Clinical Trials
Phase II and III Clinical Trials
Late Phase Clinical Trials
Post Marketing Safety Studies
Product Value and Effectiveness in Real-world
Public Health and Social Science Research
Scientic and Clinical product Support
Pharmacovigilance