During the last couple of years, I have spoken to many people whom occupy positions on all levels of the professional ladder in the world of clinical research. One thing that came up time and again was increasing disillusionment, across the whole industry, with large CROs and the service that they are (or are not, as the case may be) providing.
As a relatively small company ourselves, we speak a fair bit with pharmaceutical and biotech companies of an equivalent size who are seeking to outsource the running of trials with their product as the focus. It is increasingly common to hear complaints of trials for products developed by smaller companies being swamped by large collaborations between big CROs and big pharma companies. The reports are that the big CROs throw their A, B and C teams at the big business and the smaller studies get almost forgotten, with a motley crew of overworked and inexperienced juniors assigned to oversee them. This results in not enough attention being aimed at the smaller and more niche studies, which often means that targets are not met and endpoints not realised. This is a fact reported consistently by many small to mid-sized pharma and biotech companies. Often, in the same breath, the representatives from these companies will report that they are looking to collaborate with smaller CROs on future trials in order that the requisite amount of attention can be paid to proper process and an altogether more positive experience will lead to the desired outcome.
For some of the very small or new pharma and biotech companies, the success of taking a drug or device to market can literally make or break the business. Why, then, do they persist in allowing themselves to get lost in huge global CROs? The answer, of course, as with many things is that familiarity gives a sense of safety and security. The bigger names are familiar to most in the industry, and it’s this brand recognition that lures sponsors in. This isn’t to say, of course, that some small sponsors don’t end up having very positive experiences with large CROs, but the majority to whom I have spoken report discontent.
The advantage, for smaller pharma and biotech companies, of using a smaller CRO to manage their trials is that the trial will represent a larger percentage of the CRO’s overall workload, meaning it is generally the case that the trial and sponsor will receive more focus and attention. Much like the very small or new sponsors, a small CRO is closer to a make-or-break scenario, and therefore relies on offering a situation the breeds what fundamentally boils down to “a happy customer”.
Often, small CROs are strategic and niche and will therefore further outsource certain aspects of study management to other specialist service providers. This means that each facet of the trial is being handled by individual experts rather than the whole thing being managed by one entity with different branches. At Ixia, we handle this by keeping each additional service provider under our management umbrella, which means that we provide the convenience and appearance of a full-service CRO while retaining the focus of a niche provider.
Naturally, there is no one-size-fits-all approach, and each sponsor will have different requirements for each project, but I do sense a shift in the industry away from blindly using the big names and towards finding a more appropriate match on an ad hoc basis. The large CROs are going nowhere, but there is absolutely a place for small CROs in the research industry.