| Historically, CROs and Electronic Data Capture (EDC) vendors have not really known what to do about the other. Partner? Compete? Develop strategic alliances? It has not always been a harmonious co-existence, with many instances where the parties wished the other would just simply go away. After all, in the minds of many, the two types of organizations have represented polar opposites: CROs were supposed to be large, service-focused companies adding economies of scale for a clinical trials process that was mired in cumbersome paper-based processes, while EDC vendors were perceived as young, nimble technology companies trying to re-engineer age-old processes by using the Internet.
As time went on, there was a period when the two entities saw each other as potentially threatening, with EDC vendors providing more services that would encroach upon traditional CRO functionalities, and CROs constantly trying to appear more tech-savvy, with many developing “home-grown” EDC systems. At the end of the day, however, it’s the sponsor community that will dictate the way in which relationships will emerge, and it certainly doesn’t appear as if either entity is going extinct any time soon.
As sponsors become more knowledgeable about EDC, there is an insistence not only upon top-rate technology that is rich in features, but the service and procedural controls that would ultimately make the difference in smooth EDC deployment. Thus, with the growing interest in EDC, there is a way for CROs and EDC vendors to co-exist. The path to a happy marriage is clear, if we just step back and think for a moment.
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:
||CROs are able to integrate EDC-related budgets more effectively, making them more competitive.
||CROs are now able to capture EDC-related service costs for themselves rather than making them pass-throughs to the EDC vendor. These can be significant services for the CRO and significantly influence the CRO’s bottom line. Services include eCRF setup, EDC edit check configuration, user management, reports configuration, outputs configuration. Furthermore, modern EDC products provide Web-based tools that allow CRO personnel to accomplish these tasks after basic training.
||CROs may now use EDC as a strategic tool, versus a mere point (tactical) solution. Loss leading of EDC in contracts may give CROs access to accounts where penetration would have otherwise been difficult. For example, a CRO might decide to discount EDC drastically for a project involving magnitudes more service needs in other areas such as monitoring. This degree of flexibility and budgetary control would never be feasible in conventional EDC vendor/CRO relationships.
||CROs may now maintain better control of both client relationships and the projects conducted, improving the chances for a consistently high-quality outcome.
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.