Services summary
Feasibility
- Country feasibility for target patient population
- Enhanced site feasibility and selection
- Investigator selection and recruitment
- Site resource management – placement of in situ clinical staff
- Selection management and monitoring of local vendor and partner organisations
Patient recruitment and retention services
- Research to development
- Attitudinal research
- Demographic analysis
- Psychographics
- Creative Services
Study project and programme management
- Interact with CRO, other vendors and/or sites as Sponsor Representative to help bridge time zone differences and increase communication
- Facilitate in-person visits to assess capabilities of selected sites and vendors
- Drive feasibility to deliverablesProvide guidance to central team on local issues and problem resolution
- Maintain momentum in team and site productivity by leveraging relationships and providing motivational leadership
Outsourcing
- Assist service provider (FSP, CRO, etc)identification
- Evaluate best central versus local laboratories
- Central pharmacy, regional CTS depot logistics
Budgeting
- Support in the negotiation of localised versus centralised budgets for all providers
Consultancy
- Assistance with regulatory matters at a local regional level in emerging regions
- Assistance with Independent Ethics Committees/Independent Review Boards applications
- Assistance with local legal requirements with PI, Institution and at country commercial level
- Leverage experiences, lessons learned and relationships to support overall team objectives
- Support EC/IRBs, centralised institutes and investigational sites in emerging countries with ethics awareness and ethics training in the planning and conduct of global clinical research undertaken, to the highest international standards.
