Risk based proposals from CROs
In this article I set out an interesting suggestion. Make the process of CRO selection longer and more expensive. You may not be instantly tempted by this prospect! But read on to see why it could save you a lot of money and angst. As individual human beings, most of us are pretty careful with our money. In growing up we learn to be fairly sensible not to fall for email scams or get-rich-quick offers. Organisations that invest large amounts of money are also loathe to part with it easily. You only have to watch episodes of Dragons Den/Shark Tank, or be in business dealing with venture capitalists to realize this. Yet there is one arena that is close to many of us where we continually invest naively and it is with CROs. The statistics you may be aware of testify to this. Some say that an astonishing 80% of clinical studies fail to meet their objectives. Faced with these sorts of inefficiencies, some organisations are radically re-engineering their processes around the setup of partnerships. But the majority of deals are still done in a way that hasn’t changed for many years. Still small voices are urgently recommending change, in particular to reinforce and enhance the processes around CRO proposals and selection. CROs are still being asked to submit costed proposals at short notice, for, in many cases, multi-million dollar projects, without the opportunity to fully investigate the detail. They quite understandably assume that sponsors will shortlist based on price, reassured by the vendors' included list of experience and prior projects. Extra reassurance comes from charismatic CRO business development people at bid defense meetings, who are tasked to generate as many opportunities as possible for their companies. Deals are often signed at an agreed price and a project will kick off with optimism. Unfortunately, this turns to irritation and cynicism in many cases. Why? Because there is no substantive consideration of risk in this whole process. The most likely thing in a clinical project is that issues will crop up that require extra activity, resulting in arguments and volumes of email debate about who is going to pay for it. There is a different way and it is the ‘risk based proposal’. Instead of selecting a CRO based on their response to RFP and performance at the bid defense, I suggest you ask each of the shortlisted companies to prepare a second proposal, this time adding a costed risk analysis, using their own (likely deep) experience of the therapy area and the design you are working with. Let them take their time to do this, and perhaps even pay them to do it. What you will get in return for this are descriptions of what barriers and delays your study is actually most likely to encounter, and most likely to cost. The quality of the risk assessment is a far better differentiator for CRO selection. You can sign a deal, this time knowing in advance, to a reasonable standard of accuracy, what the real total cost is likely to be. Not only that, arising issues, other than acts of God or completely out of the blue events will have contingency plans that can be deployed immediately. Overall such a study is likely to cost less and to create a far more collaborative atmosphere then one which is planned with more hope then sensible analysis.