By Allison Proffitt 

November 7, 2023 | In clinical research, outsourcing is more of a partnership than it is just handing off work to other teams. The stakes are high, and the success of outsourcing relationships directly impact the success or failure of a pharmaceutical program. At the closing conversation at SCOPE Europe, a panel discussed the critical ingredients for successful outsourcing partnerships and which outsourcing practices actually stifle innovation.  

First, it’s not just about the money, said Piet Thiesohn, VP resource management, clinical development and operations, R&D clinical operations at Bayer. The industry should be aiming for value-based outsourcing, he argued.  

Value is created through relationship, said Jason Gubb, a clinical operations consultant and coach, and requires real vulnerability from both parties. Gubb acknowledged that this isn’t always possible, but he listed three hallmarks for building such relationships. First, such relationships require a time commitment to come to clarity on shared goals. Second, relationships should focus on the “how” as much as the “what” in those shared goals because processes matter. Third, the most successful relationships focus on co-creation of value: a new outcome, not simply collaborating to create an existing outcome.  

It’s not always easy to find such partners, Gubb conceded. He pointed the audience to ClinEco, a new platform and community created to link sponsors, CROs, service providers, and sites. The problems of vendor selection and relationship building are the ones ClinEco was designed to address. A clinical trial marketplace, ClinEco intends to enable everyone to explore, engage, and exchange capabilities with their own ecosystem of partners. 

Editor’s Note: ClinEco, SCOPE, Clinical Research News all share the same parent company.  

Julia Vassiliadou, vice president at F2G, is a proponent of new vendor connections. She contended that long-term relationships can stifle innovation. Adding new vendors certainly adds complexity, she acknowledged, but new partners bring fresh ideas and solutions to the table as well. There is also value in restating the problems and needs of the organization; the process itself brings clarity that would be lost if long-term relationships are allowed to stagnate.  

Jane Twitchen, head of the clinical trial accelerator unit and senior director of global clinical operations at Biogen, has been on her own outsourcing journey with a vendor for 18 months. The relationship is developing fruitfully, she said, because the vendor has built trust through listening to her pain points. In her example, one site had 22 portals to access for an acute care study—a very tough situation for the site staff. The vendor listened to the problem, went away and thought about it, and came back to Twitchen with a “blue sky solution” that simply and creatively met the needs of site staff.  

Sharing Risks and Costs 

Twitchen believes that the vendor partner selection process can stifle innovation at many organizations because those sorts of open, trusting relationships doesn’t develop within existing procurement frameworks. She advocates for some risk sharing between partners, where both reward each other for outside-the-box thinking, and where contracts can be creatively constructed to meet each partner’s most valuable goals.  

Over-emphasis on cost reduction also plays a role in stifling innovation, Vassiliadou said, and Gubb agreed that there should be shared responsibility for the money spent.  

In fact, relying on RFPs and competitive bids to find the right partners just doesn’t work, Thiesohn said, citing his own experience where initial bids are low-balled with plans to make up expected costs in change orders once the relationship is established. He suggested that change orders should be banned unless there has been an actual significant change since the feasibility assessment—a global pandemic, a war, or something equally impactful.