Services

1. Audit Review and Analysis
2. Regulatory Compliance Review
3. Quality Management System (QMS) Development or Improvement
4. SOP development: Writing or revising standard operating procedures (SOPs) for various activities.
5. Risk assessment: Identification and mitigation of potential risks to study integrity and safety.
6. Data Integrity and Management
7. Informed Consent and Investigator Training
8. Training development
9. Source Data Verification (SDV) Process Improvement
10. Adverse Event Reporting Review and Improvement
11. Regulatory Submission Assistance
12. Ongoing Monitoring and Support
13. Translations