Why Congruence is Critical in Clinical Trials
John Hall BS, MBA, CCRA
In geometry, two figures or objects are congruent if they have the same shape and size. In early stage clinical development, although shape is irrelevant, finding a vendor of similar size is an ideal starting point for your selection process.
When selecting a vendor, specifically a Clinical Research Organization (CRO), sponsors need to determine what services they require for the clinical trial. Once the services are determined, sponsors should initiate a request for proposal (RFP) from CROs who are capable to successfully execute your study. Traditional CRO services such as project management, trial monitoring, data management, etc… are often available at both small and large CROs. A common mistake in early clinical development is to distribute Request for Proposals (RFPs) to the largest, most commonly referenced CROs. It is not a factor of experience. Large CROs, typically publically traded, have conducted thousands of clinical trials and likely hundreds of trials inside your target indication. The mistake is an oversight of congruence. Small biotechs have small teams and usually a limited runway, but what they lack in size and resources they make up in passion. The investigational drug/biologic/device is their baby and assuming only large CROs can optimally provide these services is a critical mistake. Small biotech companies should target CROs of similar size.
Common Assumptions Should be Examined
Too often large CROs are selected only to fall short in meeting the needs of small biotech companies. Communication is critical but communication also requires time and time equals money. Some larger CROs have created business divisions that specialize in serving the needs of biotechs. Early stage biotech companies need a partner who they feel is a partner in development. A vendor that they are in the trenches with, a partner who understands that the initial trials need to be delivered on time and on budget, and a partner who will view the sponsors trial as their own. Large CROs are efficient but also well managed to only provide the services they are contracted for. Too often sponsors are not aware of the services or the nuances of said services to properly scope the work order. This lack of experience can lead to insufficient delegation of responsibilities, mismanaged trials, frustrated sponsors, and eventually change orders. Of course these experiences are not limited to large CROs, but the smaller CROs are typically better suited for the smaller early trials and small sponsor teams. As sponsors progress through clinical development what was once not desired will become ideal. Larger CROs are more experienced with vendor management, integrated services, and complex multi-national studies. What was once considered “bells and whistles” and an unnecessary cost can ensure your trial timeline stays on track in larger phase 2 and phase 3 trials.
Key Take Aways
A properly executed RFP can avoid many of these common mistakes. Identifying ideal CROs for consideration, a clear description of services required, a clear list of team responsibilities and a willingness to consider CRO recommendations can ensure quality studies are delivered on time and on budget, but the funnel starts with the ideal CROs for consideration.
John Hall is a clinical operations specialist with Omar Consulting Group. He can be reached at info@omarconsulting.com and johnhall@regerhall.com