INC Research, a therapeutically focused CRO, has entered into a Functional Service Provider (FSP) alliance with Astellas Pharma to drive global consistency, save time and reduce costs for multiple clinical development programs across several therapeutic areas.
In an initial three-year agreement, INC Research will deliver key functional services to Astellas, including clinical monitoring, clinical data management, trial master file management, site start up and study feasibility activities. Work began April 2 and is being conducted globally.
"INC Research has worked with Astellas on several full-service development programs where our teams have created strong bonds and deep level of trust, and we are excited to extend that relationship through our FSP alliance," said James Ogle, CEO, INC Research. "With mutually agreed expectations and insight into Astellas' development pipeline, our dedicated teams will utilize our innovative tools and proprietary processes to efficiently manage these clinical development elements and drive global consistency across development programs."
INC Research has established a dedicated business unit for delivery of the FSP services to Astellas, allowing for independent, cross-functional resource management and training of company staff committed to the partnership. An executive governance structure has been implemented for management of the relationship, with plans to leverage key metrics to drive decision making and ensure continuous improvement across the alliance. Success will be measured based on operational delivery, effective collaboration and process and technology innovation.
INC Research's FSP model has an end result of greater cost predictability and delivery of consistent services across all protocols. The model has proven to reduce costs by up to 40% and generate time savings of 10-20% over the course of a relationship.