Services Offered

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 Training
• Customised workshops

Investigator Sites

• Clinical Trial Site Development including design of trial site
• GCP and other Trainings
• 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


A consulting agreement is required prior to the onset of any work.

The agreement will outline the scope and nature of the work to be done.

Mutual confidentiality agreements are required prior to the onset of discussions of any proprietary information.