Standard Operating Procedures

«BioEq» SOPs cover the following aspects:
  • SOPs and Work Instructions Development and Implementation
  • Confidentiality of Data
  • SOP deviation 
  • Development, review and approval of Informed Consent Form
  • Obtaining Informed Consent
  • Investigator File maintenance
  • Interaction with Independent Ethics Committee and authorized bodies
  • Safety reporting
  • Conduct of resuscitation procedures
  • Study subjects enrollment
  • Source documentation
  • Staff training and employee`s personal folder
  • Equipment maintenance
  • Abbreviations list
  • Study documentation archiving
  • Quality standards incompliance
  • Premises usage and actions during emergency situations
  • Biological samples handling
  • Investigational product handling
  • Data entry and CRF completion
  • Study monitoring
  • Selection of and interaction with goods and services vendors
  • External and internal audit
  • Hiring and Termination
  • Correspondence policy
  • Documentation Maintenance
  • Agreement Approval
  • Archiving of Documents
  • HR documentation Maintenance