© 2018 by CRN 

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.

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  

PROJECT MANAGEMNT
  • Assessing  Study Feasibility.

  • Study  StartUp..

  • Investigational  Product Management

  • Source  Documentation.

  • Monitoring  Visits.

  • Study  Completion  Compliance 

QUALITY ASSURANCE
  • Quality Assurance Audits

‚Äč

  • Inspection by Regulatory Authorities 

SUBJECT MANAGEMENT
  • Subject  Recruitment  and Screening

  • Informed  Consent.

  • Eligibility  and Enrollment.

  • Protecting  Confidential Information.

  • Subject  Visits  and Assessments

  • AE  Management.