Functional Service Provider (FSP) Services
Under this service, TK-CHAIN® provides staff to biotechnology and pharmaceutical companies in order to perform specific tasks —in a dedicated manner— on a contract basis and under the procedures of the sponsor/client. Combining the expertise and stability of a large CRO with the dedication and agility of a small CRO, TK Chain’s FSP services deliver a flexible mix of functional expertise, resource management, and technology-enabled solutions for the client’s development programs. TK-CHAIN® has in its talent pool, FSP experts ready to scale trial resources, accelerate timelines, and maximize efficiency throughout development. The benefits for contracting TK Chain’s FSP services include:
- Scalability of workforce and Flexibility: Workdloads can be shared across monitors and increased flexibility allows the quick movement of resources across therapeutic areas, sites and/or from one study to another depending on the operating model and strategy of the sponsor company.
- Monitoring: Direct data sharing and transfer with the client/sponsor’s clinical trial management system (CTMS) and other management systems. This allows for collaborative data review in realtime. The company also operates a comprehensive performance scorecard to control quality and productivity levels to ensure all the monitoring is expedited as efficiently as possible.
- Cost saving: Efficiencies from TK Chain’s FSP model create immediate cost savings such as the workforce being of the appropriate strength versus the workload required. A significant but indirect cost saving is the time efficiencies, making it possible to get a drug to market sooner i.e. a reduced cycle time.
TK Chain’s full suite of FSP services includes:
- Clinical Monitoring
- Clinical Study & Project Management
- Data Management
- Statistical Programming
- Biostatistics
- Pharmacovigilance
- Regulatory Operations
- Medical Writing
- Medical Affairs
- Translational Medicine