Via Maggio 1C, Lugano 6900, Ticino, Switzerland
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