Outsourcing is Changing — Do We Need Stronger Partnerships?
There’s no question that clinical research outsourcing is here to stay, but recent macro-level industry trends are forcing sponsors and contract research organizations (CROs) to change how it’s done. Sponsors are seeking opportunities to be more efficient while also mitigating the risks involved, which requires a greater level of sponsor-CRO collaboration than ever before. What exactly is driving this need for better collaboration? Firstly, sponsors are not only outsourcing purely transactional activities like site monitoring and data management; they are also starting to outsource more complex activities, such as statistical services, regulatory interactions and headquarter operations. However, these require more strategic partnerships and deeper collaborations for support. Secondly, CROs are finding geographically, therapeutically and functionally focused niche markets in which to offer their services. And sponsors are taking advantage of these niche services, thereby increasing the number of CROs that a sponsor will outsource to at any one time—in fact, some sponsors work with more than four CROs at a time. Managing multiple CRO relationships is complex, and sponsors rely heavily on their CROs to provide frequent and proactive information about trial progress. Lastly, increased economic pressures, more frequent mergers and acquisitions and licensing deals, and greater variability in funding mean that sponsors need to be able to quickly scale project resources to match the peaks and troughs of resource availability. However, flexibility to make resource changes requires strong ties between sponsor and CRO. So what’s changing? It’s not only important that sponsors and CROs clearly communicate and agree upon shared goals to work towards; there also needs to be frequent and proactive exchange of information about trial progress during the study. Yet, at a time when collaboration is paramount, today’s outsourcing environment is becoming increasingly virtual, making these relationships and interactions more difficult to manage via disparate clinical systems. An ecosystem of interoperable systems that allows sponsors to access CRO data, and connect to real-time trial information, is key to outsourcing in today’s environment. What are you doing to build stronger partnerships? *Attending ClinTech 2013 in Philadelphia, PA, March 11-13? Don't miss Marcus Thornton's talk, "Leverage CTMS Interoperability to Strengthen the Virtual Outsourcing Model," on Tuesday, March 12 at 10:15 a.m. Also check out Marcus Thornton's video blog post, "Getting SaaSy with CTMS." Guest blogger Marcus Thornton is senior director of CTMS at Medidata Solutions. You can reach Marcus by email.