While many Sponsors rely on CROs for most clinical development functions, delegating RTSM vendor selection and management may create undesirable complications and lesser outcomes. Although RTSM represents a relatively small portion of a study’s budget, it’s a lynchpin that can make or break a study’s success.
“We’re not big on bundling all our vendors with our CRO,” explains one Head of Clinical Operations the Korio team recently interviewed on the topic. “We take ownership of certain pivotal vendors because we want to be able to get directly to the vendor if something does go wrong, and not through a go-between.”
While it may be tempting to bundle the RTSM with other outsourced services for the sake of simplicity or perceived upfront cost savings, Sponsors that maintain a direct relationship with their RTSM vendor see three significant benefits:
1. Rapid Response & Resolution:
Clinical trials do not exist in a frictionless environment; there are practical operational issues involving site shipments, medication storage, lost IP, and any variation of confusion that requires immediate resolution to ensure trial continuity, (i.e., patient treatment assignment). With the CRO as the intermediary, basic troubleshooting conversations can get bogged down in a game of telephone- more complex scenarios can become nearly impossible to resolve in a timely manner.
“When something goes wrong with drug supply or site access, we need it fixed now, not after three days of back-and-forth,” notes the same Clinical Operations leader. Direct vendor relationships mean more rapid response when it matters most.