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 MANAGEMENT
-
Subject Recruitment and Screening
-
Informed Consent.
-
Eligibility and Enrollment.
-
Protecting Confidential Information.
-
Subject Visits and Assessments
-
AE Management.
QUALITY ASSURANCE
-
Quality Assurance Audits
-
Inspection by Regulatory Authorities
PROJECT MANAGEMNT
-
Assessing Study Feasibility.
-
Study StartUp..
-
Investigational Product Management
-
Source Documentation.
-
Monitoring Visits.
-
Study Completion Compliance
SOPs STRUCTURE
GENERAL ADMINISTRATION
-
Ensuring Qualified Site Personnel
-
Fulfilling Responsibility for GCP
-
Records Management, Accountability
-
Retention
-
Contracts
REGULATORY AFFAIRES
-
Essential Documents
-
Submission
-
Reporting requirements
-
Conflict of interest
DATA MANAGEMENT
-
Clinical Data Management
-
Use of Electronic Data Management Systems