Lessons Learned
There’s always a learning curve, and many an EDC project has gone awry with CROs, EDC vendors and sponsors pointing fingers. But what exactly are the rough spots and how can we learn from past experiences?

Frequently, the problem starts right from the selling process. CROs have traditionally sold through large volumes of RFI (request for information) grinding, while EDC vendors have achieved their greatest success through grass-roots “press-flesh” techniques with hopes of demonstrating to sponsors the value propositions behind their systems. As interest grew with the sponsor community, CROs suddenly started seeing numerous RFIs with a component for EDC. CROs then found themselves scrambling to create relationships with EDC vendors at the last minute. Thus the emergence of “yellow pages” syndrome, whereby CROs would call on all the vendors listed under the “EDC” category of the phone book in hopes of finding a suitable partner. At the receiving end of this syndrome were the EDC companies, eager to be involved in new business, but with no knowledge of the sponsor’s true needs, compiling hundreds of pages in polished RFI responses, usually with no time to spare. Unfortunately, the end result tended to be a mere sum of the parts: garbage. Sponsors saw it right away too, with redundant budgets, project teams that had never worked together, and lack of prior due diligence for regulatory compliance and standard operating procedures (SOPs).

Even after a project was awarded, implementation was a challenge. CROs naturally felt protective of their relationship with the sponsor, while EDC implementation led to greater visibility of the EDC vendor’s project team and its expertise. CROs tried to “manage” the EDC vendor without a full understanding of the technology, and naturally, projects were put at risk.

History Repeats Itself
Software products that survive the test of time achieve a level of adoption such that users see it as a gold standard and can’t even imagine what life was like in the days prior. While EDC isn’t quite at that point yet, adoption is rising steeply, and success stories are more evident. We can safely say that EDC is here to stay and ultimately will attain survivor status.

As software products begin to weave themselves as standard in any industry, the mentality of users looking to select a software product shifts from technology to implementation, and then from implementation to support services. A true sign of maturity in any software’s existence is the degree of community and implementation expertise that exists among its users. For example, if you examine the technology of Business Objects, the global leader in providing business intelligence software, volumes of support documentation exist. In addition, user communities seem to crop up organically, discussion forums appear spontaneously on the Internet, and the software begins to develop its own identity through its users. As this occurs, the focus of attention shifts from the scrutiny of evaluating a technology’s functionality, to the service and expertise available by those qualified to provide it.

In the clinical research industry, this is exemplified in the software products used for clinical data management. While virtually every CRO with data management services has a data management technology, there is little scrutiny by the sponsor to determine whether or not the technology is able to meet a set of user requirements. Rather, the focus falls appropriately upon the CRO, which has invested the resources in learning the technology to the point where it can consistently deliver a quality product. This is made possible because the CRO has embellished its services to support the software in a way that makes it unique. This is accomplished through a combination of user training, SOPs, documentation for best practices, and implementation expertise. Thus two CROs using the same data management software might arrive at a different end product, with different degrees of process efficiency. Simply put, this is a CRO’s differentiator, and it’s appropriately focused on the services that are wrapped around a given technology, and not the technology per se.

EDC is moving in the same direction, and the most strategically minded CROs are starting to figure this out. It’s a good thing too, since it’s turning into a formidable competitive advantage, significantly driving business and positively impacting the bottom line. On the other hand, CROs that still see EDC as a point solution for RFI responses are still doing endless vendor evaluations, creating meaningless “preferred provider” lists, and unnecessarily burning a lot of midnight oil.

Going Forward the Right Way
In concrete terms, what really needs reckoning in the CRO/EDC dynamic? CROs need to approach the technology of EDC the way they approach the technology behind their clinical data management by putting in the investment to train their personnel on the subtleties of EDC and develop SOPs that will maximize the software for their particular organization. CROs must identify an EDC technology that best suits their needs and adopt it as their own, with participation in the dialogue and idea exchange of any users’ community that ultimately fosters expertise. EDC vendors likewise need to position their business practices and software architecture to accommodate CROs, and view the CRO community as an important end-user community. Only in this way can CROs and EDC vendors begin to seize opportunities to work with sponsors, which are rapidly becoming more sophisticated with EDC. Only then can CROs begin to truly market themselves as EDC-savvy. Once CROs begin to use EDC to their own advantage, dynamics in the EDC vendor-CRO relationship change in very positive ways, some of which are detailed below:

The industry of contract research has contributed significantly to the effectiveness of Pharma and Biopharma as an invaluable resource. EDC should be seen as a means of further strengthening that resource. Once CROs are able to address EDC in the same manner as they do data management technology—through in-house expertise, adoption, processes and even sales—the universe of CROs with EDC vendors will reach equilibrium and go forward in harmony.