Sites SOPs in compliance with FDA Regulations
Our SOPs are fully dedicated to SMO and sites activity and are in compliance with FDA Regulations.
- Subject Recruitment and Screening
- Informed Consent
- Eligibility and Enrollment
- Protecting Confidential Information
- Subject Visits and Assessments
- AE Management.
- Quality Assurance Audits
- Inspection by Regulatory Authorities
- Assessing Study Feasibility
- Study StartUp..
- Investigational Product Management
- Source Documentation
- Monitoring Visits
- Study Completion Compliance
- Ensuring Qualified Site Personnel
- Fulfilling Responsibility for GCP
- Records Management, Accountability
- Essential Documents
- Reporting requirements
- Conflict of interest
- Clinical Data Management
- Use of Electronic Data Management Systems