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