We’ve seen a significant increase in the number of site visits taking place over the last few weeks. For some CROs this is a return to business as usual where source data verification (SDV) is the monitoring approach of choice because it drives their revenue. But there’s a problem looming for CROs following that route.
There’s been a sharp upturn recently in the number of study RFPs coming out from Sponsors according to our CRO partners. That’s good news for the industry as a whole, but there’s a subtle, but very important shift in those RFPs. Sponsors are building quality risk management into the Protocol designs, including the need for direct data capture, remote and central monitoring. This reduces the need for on-site visits and makes the process of SDV irrelevant – there is simply nothing to verify. If there is one silver lining to the pandemic it may just be that it is another nail in the 100% SDV coffin.
For those organisations still depending on SDV as a quality management strategy, the question is “What are you going to replace it with when there is nothing to SDV?”