Need a CRO? How to Take Advantage of Newer Business Models
For many years now, the pharmaceuticals industry has witnessed a persisting debate about the relative merits of working with a specialized versus full-service CRO. Newer business models have changed the nature of the decision, however, making old concerns obsolete and introducing new ones. In light of this, what new factors should shape decision-making on this pivotal issue? This article looks specifically at how to make this choice for CROs specializing in data management and biometrics.
Conventional versus Integrated Business Models
Let us begin by examining the difference between the old, ‘conventional’ business model and the new ‘integrated’ model for specialized CROs. The conventional model had CROs, which came in one of two forms. There was the full-service CRO which served as a one-stop shop for all of your outsourcing needs. Alternatively, there was the specialized CRO, which fans called the best-in-class model. Although specialized CROs did not provide all the services a sponsor might require, the “best-in-class model” moniker referred to the fact that the services which were offered were provided by some of the best qualified leaders in the industry. As a result of this expertise, sponsors would be willing to pay slightly more for their services.
The integrated model is slightly different from a full-service model, although resembles it at many levels. It is the result of best-in-class specialized CROs forming partnerships to provide something comparable to a one-stop model. In an integrated model, your chosen vendors depend on the nature of the project. For example, you might have a specialized biometrics CRO that outsources its randomization services. Depending on whether your trial is of a conventional or modern design, it might outsource to one partner or another. Both vendors work with the biometrics CRO in question, but on different kinds of projects. In theory, this means that you get the best vendors for your particular project, selected amongst one or more of your vendor’s partners.
Individual Expertise and Winning Teams
The decision about whether or not to use a specialized biometrics CRO is critical given how dependent a trial is on clean, reliable and usable data provided in a timely fashion. Obtaining such high quality data within reasonable time frames requires constant collaboration between project statisticians and data managers.
The only problem is that capabilities for such seamless collaboration vary substantially between organizations and amongst partnerships. Determining whether a CRO can deliver seamless collaboration requires a thorough audit. Even after doing so, however, it is unclear which team in a firm will be working on your project, and whether or not there will be a turnover rate within the chosen firm. What happens when your perfect team breaks up because the leader has been offered a different job, and the second has been reassigned to a different project?
So a sponsor needs to determine both the expertise available at the individual level and at the team level. How long has this team been together? How well do they function as a team?
Strategies for Sponsors
Whether working with a full-service or a specialized CRO for its biometrics experts, what a sponsor needs is to demand the best team at the firm. This is easier at a smaller CRO as you know who the best teams are. Even at larger CROs, though, you can ask for teams that have worked together the longest and have delivered well as a group.
Another available option at a smaller CRO is leveraging the integration model for your benefit. A team accustomed to the partnership model should be able to integrate seamlessly with yours. Specialized CROs find it easier to become a part of the sponsor’s team, particularly if the members of the team have been working together for several years. The structure of a team that has worked together for so long means that team-members are aware of each others’ competencies, are practiced in communication and transparency, and can usually facilitate project completion within a shared time-frame. They can align as one seamless unit with the teams of small or mid-sized pharmaceuticals.
In short, an expert team might have experts on it, but they can offer you much more than this. Audit for internal efficiency by all means, but then ask how this team functions and how long it has been functioning in this manner. Find a team that can integrate well with your own. Remember too that an integrated model is still best-in-class. It is simply an improved version of conventional organization.