NC Research, LLC has entered into a Functional Service Provider (FSP) alliance with Astellas Pharma Global Development, Inc. (Astellas). The alliance is intended to "drive global consistency, save time and reduce costs for multiple clinical development programs across several therapeutic areas," according to a joint statement. In the initial three-year agreement, INC will deliver key functional services to Astellas, including clinical monitoring, clinical data management, trial master file (TMF) management, site start-up and study feasibility activities. Work began April 2 and is being conducted globally. Financial terms were not disclosed.
"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, chief executive officer of 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.