Clinical trials can be dauntingly complex. The high-stakes culmination of years – sometimes decades – of research, they involve rigorous data requirements, close regulatory scrutiny, intricate logistics, and intense cost pressures. Add the stress of trial outcomes sometimes being a make or break proposition for the sponsor, and it makes sense to hire a professional management team who are experts in delivery execution: a clinical research organization (CRO).
Such an arrangement allows biotech and pharmaceutical companies to concentrate on the science that is their core strength, while leveraging the CRO’s intellectual capital and operational experience. It provides time efficiencies and economies of scale, eliminates the potential for perceived conflicts of interest, and may be useful navigating regulatory roadblocks.
At best, it can be a formidable foundational relationship that powers dozens of trials yet, at worst, if not approached properly, it can doom the trial that it is meant to bolster.
Let’s examine the reasons a Sponsor-CRO relationship may struggle, and a few simple techniques that can ensure it is not only robust, but that it helps advance the success of the trial.