New, strategic outsourcing models to meet changing clinical development needs

Abstract

The impact of increasing clinical costs and the need for more data to support higher efficacy demands and overcome regulatory hurdles for market entry means that every Company is faced with the challenge of how to do more with a smaller budget. As budgets get squeezed the pharmaceutical Industry has been looking at how to contain or reduce cost and support an increased number of projects. With the growing sophistication of outsourcing, this is an increasingly important area of focus. Some Pharmaceutical Companies have moved from tactical, case by case, outsourcing to new, more strategic relationships, which involve outsourcing functions that were historically held as core pharmaceutical functions. An increasing number of Sponsors are looking at strategic relationships which are based on more creative outsourcing approaches. As the need and sophistication of these outsourcing models and the sponsors / CROs involved in them, these approaches are becoming more transformational and need to be based on a strong partnership. Lessons learned from working with sponsors in a partnership model have been examined and two key challenges addressed in detail: the need for bilateral central control though a strong governance model and the importance of early planning and commitment.

Keywords

• CRO / sponsor partnerships
• outsourcing
• governance
• feasibility