Sponsors and CROs

• Strategic development and scientific advice
• Protocol development
• Feasibility
• Site selection/Set up/Readiness
• Regulatory affairs
• Clinical Trial /CTF 1 submissions
• Project Management
• Patient recruitment strategies
• Clinical trial operations
• Enrolment performance
• Due diligence
• Quality Management
• Site preparation for inspection/Mock regulatory inspections
• Gap analysis on partner processes and process improvement
• Research Capacity and Transformation Development

GCP and other Trainings (through Research Ready Training)

• Customised workshops

Investigator Sites

• Clinical Trial Site Development including design of trial site

GCP and other Trainings (through Research Ready Training)

• Mentoring and Site Support
• SOP development
• Study Start up and Study Management
• Preparation of Ethics and Regulatory documentation
• Gap analysis and Process Improvement of the clinical trial site
• Patient Recruitment strategies
• How to build an effective recruitment and enrolment plan
• Regulatory/Investigator Site Files
• Implementing Quality Control and Quality Assurance at site level
• Prepare for regulatory inspection/ Mock regulatory Inspections
• Business Development
• Assistance with budgets/budget negotiation, invoicing, debtors analysis and financial administration
• Research Capacity and Transformation Development