Our Services
 


Our Services

From Concept to Cure

Running clinical trials, of whatever size and complexity, requires efficient management. The Aga Khan University’s Clinical Trials Unit is a one-window operation from study start-up to close-out.

Key Services

  • Protocol development
  • Development and management of contracts – including clinical trial agreements with funding agencies, study sponsors, contract research organisations, internal and external site investigators
  • Preparation and submission of ethics applications – plus amendments and annual reports
  • Conducting site initiation meetings and visits with stakeholders and study teams
  • Preparation and maintenance of trial master, site and pharmacy files
  • Regular safety and data monitoring along with protocol complains as per local and international guidelines
  • Financial oversight to ensure compliance with financial agreements and monitoring expenses
  • Liaison with investigators, regulators and sponsors to ensure timely submission of reports and invoices
  • Management of study close-out  processes
  • Archiving of documentation for 15 years or as per study/sponsor requirements

Ancillary Services

  • Drug/Investigational product management
    • Procurement, storage and dispensation of drugs for the study
    • Maintenance of drug inventory and accountability logs
    • Generation of randomisation lists and tamper-proof envelopes
  • Development of adverse event and data management systems
  • Workshops on Good Clinical Practice training, protocol writing and standard operating procedures