The unpredictability of clinical trial scheduling and timelines is a ‘given’ in the world of pharmaceuticals. Seasoned professionals have learned the hard way that one’s chosen vendor in any given domain may not be sufficient to handle whatever comes along — in particular, the tendency of multiple studies, originally scheduled to begin at nicely manageable intervals, to suddenly bunch up in the same month or quarter. In addition, variations in study needs, size, and rules of conduct makes it hard to find a ‘one size fits all’ strategy. At the same time, establishing standard processes and patterns with a given vendor of choice has long been recognized as the most cost-effective and efficient approach to maintain consistency across trials. What to do?
Discussions at recent conferences of clinical trial professionals make clear that an increasing number of Sponsors and CROs of all sizes are overtly pursuing a dual-vendor strategy when it comes to key services like Interactive Response Technologies (IRT). Selection of a secondary (and in some cases, tertiary!) IRT vendor is increasingly an additional step in formal search strategies. Two different approaches were revealed. In one approach, secondary vendors were simply held to the same success criteria as were the winners of the primary search. In another approach, a subset of criteria were held in common between primary and secondary vendors, but with other, different criteria considered for the secondary vendor. For example, while a minimum company size might be a vital criterion for the primary vendor, the benefits of a smaller team — with increased flexibility and speed of response — might move to the top of the list for a secondary partner. Likewise, differences in customization costs and configuration practices might be paramount if smaller studies and/or ‘pinch hitting’ is to be a secondary vendor’s primary role. A smaller vendor who emphasizes ease of configuration may, for example, eclipse a second larger vendor who relies more heavily on up-front, franchise customization. In any case, the key to choosing a secondary vendor is to take the time to develop a clear understanding of what constitutes a winning set of secondary capabilities for your company’s given needs.