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CRSU Services

Services include:

Clinical trial management and co-ordination

  • Clinical Trial Planning in accordance with ICH-GCP
  • Oversight and governance of clinical trials ( regulated and unregulated)
  • Development and maintenance of Clinical trial documentation within ¬†standard operating procedures and research protocols
  • Clinical trial monitoring
  • Inspection readiness

Research nursing support

  • Consent processing
  • Clinical trial document maintenance during research in order to demonstrate compliance to applicable regulatory requirements and standard operating procedures
  • Entering data into research databases including electronic databases/eCRFs
  • Ensuring that specific protocol is followed and deviations minimized
  • Biospecimen Collection

Protocol development

Assistance and advice with submission of ethical and regulatory documentation

Statistical advice