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 report
• 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