There exists a great paradox in clinical research departments of commercial entities. These entities could be sponsors (pharmaceutical, biotechnology, and medical device companies) or CROs. On the one hand, these departments are supposed to embody the inquisitive mindset behind a clinical trial, driven to evaluate the potential of a drug, therapy, or device that may cure or diagnose a disease state and help alleviate the associated pain and suffering. On the other hand, they operate in a state of fear. They fear operational change.
It is understandable to fear change to the extent that it can subvert the necessary controls of a clinical trial. But this fear has seeped deeper, and moved beyond the necessary process controls to conduct an objective scientific inquiry. It is a fear of change, specifically operational change. This fear is manifested in surprisingly conservative mindsets in departments that are allegedly founded on inquisitive inquiry. The justification is that there is too much at risk to make “unnecessary changes.” But if change is not a constant in the environment, then the stakes will only get higher and at some point in the future, change will have to be made when the pain of inaction exceeds the pain of action. It does not have to be this way.
Another unfortunate occurrence in Southern California is drought. Unlike a wildfire, drought conditions don’t compel the majority of Southern California to “do” anything. A fire department can’t rush to the scene of a drought, aircraft can’t fly overhead, news teams can’t get live action shots of a drought. And yet it is very real. The mindset seems to be that this is somehow beyond their control. Considering the amount of swimming pools and golf courses in the area, one would think that water was very abundant in the area. However, no one seems to want to think differently and the expectation is that somehow the residents can outlast this current crisis and they will “figure it out” at some later point. In other words, they are afraid to make a change and are paralyzed by that fear to be trapped in a worsening cycle.
A parallel can be drawn with the expensive yet technologically lagging EDC systems used in clinical research. Once an EDC tool is in place, no one wants to touch it or improve upon it for fear that it would break too many existing processes. However, by not demanding upgrades, the sponsors and CROs enable the software vendors to get complacent and continue to charge high prices for less than innovative technology. Efforts are undertaken to upgrade and patch the systems but these simply add to the overall cost. Similar to the drought conditions, damage is being done, but it is ignored because it is not perceived to be “actionable.”
In clinical research departments, where the phrase “that study is too expensive to run on the EDC system” is still unusually common, no one seemingly demands an explanation as to why the EDC system costs so much. What is it about the technology that warrants such an expensive price tag? After all, considering that the cost of technology continues to plummet, why is it that somehow EDC systems defy this trend? We hear the usual protectionist talking points from insiders interested in protecting the status quo. “It’s a regulated market,” seems to be the most common excuse. So is banking and finance yet we are able to trade stocks and conduct the majority of our banking transactions on our smartphone. There is an obvious answer: supply and demand. Simply put, EDC companies will continue to charge high prices for sub-optimal technology for as long as they can.
Clinical Studio is the solution to break out away from the EDC systems that are stifling research due to their high cost. Users can sign up automatically and conduct single studies for free and scale up to an enterprise infrastructure on demand. Let it rain! And we all know, when it rains, it pours.