Functional Services
Site Contract Management, Regulatory Document (eTMF) Processing & Site Payment Administration |
Sponsors have been challenged to review their approach to key functional areas of clinical research that are not core to their clinical development business in an effort to dramatically improve efficiency. INC Research's Functional Service Provider (FSP) model has proven to be an effective tool for this purpose and can have the effect of reduced costs (30-40% direct cost savings on top of larger indirect cost savings), faster cycle times and improved quality.
The FSP model targets the separation of core/non-core capabilities within the sponsored organization. INC Research's competencies in providing functional site contract and budget negotiation, regulatory document (electronic trial master file) processing and site payment administration services globally have evolved from high volume strategic relationships with biopharmaceutical sponsors. INC Research has deployed our functional expertise across multiple studies in programs, therapeutic areas and pipelines and passes the efficiencies gained from industrializing these functions on to its FSP partners. Our ability to work within a sponsor's processes and systems or to deliver new processes to the sponsor allows us to act as the sole subject matter expert for a particular function. INC Research uses this functional expertise to become a subject matter expert for a particular function. INC Research uses this functional expertise to drive a continuous process improvement approach into the sponsor's current operations.
The end result of implementing a FSP approach is greater predictability and more consistent delivery of services across all protocols. INC Research currently operates global FSP hubs in Asia, Europe, North America, and South America and can become your functional expert while your in-house teams focus on the science and strategy of executing a successful clinical trial. |
Leadership
Todd M. Esporas, JD, MBA
Executive Director, Contracts & Functional Services
Victor D'Arcy Smith
Director, Contracts & Functional Services
David Ebert
Director, Contracts & Functional Services
Brandi Walker
Director, Contracts & Functional Services
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