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

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  • 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