Systems and processes

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Systems and processes

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To maintain accountability and oversight over our clinical trial operations we employ a comprehensive set of processes and systems to ensure we adhere to high standard of best practice.

Processes are guided by a set of Standard Operating Procedures

  • monitoring of Electronic Medical Records (EMR)
  • ethics and governance
  • contracts and fees
  • insurance and indemnity
  • Investigational Product (IP) management and dispensing
  • invoicing and payment terms
  • consent process
  • training (protocol specific, Good Clinical Practice (GCP))
  • maintaining clinical trial equipment
  • documents and record management including archiving
  • biological sample collection, handling and shipping
  • safe transport of biological samples - International Air Transport Association (IATA) Dangerous Goods Regulations (DGR)
  • safety reporting
  • data entry and query resolution

Systems available at site:

  • MediClinic (EMR)
  • Clinical Trial Management Systems (CTMS)
  • Documents and record management (Trial Master File, Investigator Site Files)
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