“Pharmaceutical companies will increase their use of outsourcing providers during the development process, but will experiment with a number of outsourcing models to improve quality and reduce costs,” the report says.
Kenneth Getz, Director of Sponsored Research Programs at Tufts, told Outsourcing-Pharma.com that there are several factors driving the growth. “One major factor is the downsizing and consolidation that has taken place among major Pharma companies. Their pipeline activity is very high but they are operating more leanly and relying heavily on outsourcing to provide a broad spectrum of R&D services. Another major driver comes from rising demand from smaller pharma and biotech companies that are facing better economic conditions including easier access to capital.”
The prediction follows a report from Tufts in October, which explained that although some of the top-tier CROs are engaged in strategic partnerships that shift more of the burden of designing and running the trial to the CRO, sponsors will still rely on a mix of transactional and strategic partnerships.
The report specifically hones in on how sponsors continue to rely on multiple CROs, which occasionally causes operational issues, and could lead to a re-thinking of ways to make the partnerships more efficient.
“Simultaneous and inconsistent use of contract research organization (CRO) partners to support project- and program-specific responsibilities is causing operating friction and inefficiency, which will lead some sponsors to rethink their outsourcing strategies,” the report says.
A re-thinking of whether CROs should continue to be involved in strategic relationships may also be due.
The report again points to the center’s study on strategic partnerships, noting that although they may result in fewer change orders -- which are defined as formal, written changes to the original scope of a work agreement – “due to greater shared upfront planning” and “more operating autonomy transferred to contract service providers,” the study found “no difference in the frequency of change orders between traditional transactional relationships and strategic alliances. This suggests that the latter have a limited impact on development efficiency.”
In fact, a survey by the center found that change orders for Phase II and III trials were actually higher for strategic relationships than transactional relationships.
Shifting Trial Landscape
Data are also likely to play an increasingly important role in the way that clinical trials are conducted and assessed.
“Sponsors and CROs will make greater use of large structured and unstructured datasets to perform predictive analytics, refine research agendas and protocol designs, identify and engage study volunteers, gather real-time management metrics, and improve regulatory submissions,” the report says.
The report further predicts that private equity will consolidate the global investigative site landscape to drive up efficiencies “as sponsors and CROs demand higher levels of performance in recruiting and retaining volunteers at contained costs.”