INC Research, the US-based company that last year vaulted into the top ranks of global clinical research organisations (CROs) by acquiring Kendle International, has entered into a Functional Service Provider (FSP) alliance with Astellas Pharma Global Development for multiple clinical development programs across a number of therapeutic areas.
Under an initial three-year agreement, INC 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 has already begun on the alliance, which is designed to drive global consistency in clinical development while saving time and money.
INC has established a dedicated business unit to deliver the FSP services to Astellas, which allows for independent, cross-functional resource management and training of company staff involved in the partnership.
An executive governance structure has been implemented to manage the relationship, with plans to leverage key metrics that will shape 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 noted.
As chief executive officer James Ogle pointed out, INC Research has already worked with Astellas on several full-service development programmes, “where our teams have created strong bonds and deep level of trust”.
The CRO says it is among the pioneers in developing the FSP model, which aims to improve productivity in key service areas for biopharmaceutical customers through strategic commitment and performance-based measures.