5 Qualities to Consider When Selecting Clinical Pharmacology Units for Early Drug Development

When it comes to selecting clinical pharmacology units (CPUs) for Early Clinical Development, oftentimes Sponsors and CROs are only concerned with selecting units with large bed capacity and high-volume enrollment capabilities. While fulfilling these conditions are typically the most imperative when selecting a CPU, there are a number of additional vital qualities that are shared by high-performing CPUs which should be considered. Typically, items such as costing, staffing, vendor management and selection, procedural capabilities, quality, and safety are of top considerations to the conduct of most early development programs.

Coming from a both a CRO and CPU perspective, WCCT Global offers insight into the five qualities that are most indicative of a high-performing, optimized Phase 1 clinical pharmacology unit. Having these qualities can serve to offer Sponsors significant benefits beyond large bed capacity and high-volume enrollment, such as substantial cost savings, guaranteed risk mitigation and contingency planning, and the ability to execute various protocol requirements in the most economic yet efficient way possible. 

In addition to discussing these five qualities shared by successful CPUs for Early Clinical Development, WCCT Global’s President of Early Clinical Development, Jon Rojas, will discuss the ways in which sponsors and CROs can begin proactively encouraging their pre-approved sites and CPUs to engage in these measures and incorporate them as standard operating procedures, ensuring that CPUs are offering the highest value possible to their clients while still maintaining quality and safety during the conduct of any early phase clinical program. Additionally, sponsors and CROs can utilize this information and set expectations for the selection of new sites to be added to their shortlists.

Lastly, Mr. Rojas will present a recent WCCT Global case study demonstrating the tactics and strategies that can be requested by sponsor companies and implemented by Phase 1 sites to fit into the emerging paradigm of the full-service, high-performing CPUs which are being sought after by companies still investing heavily in early clinical development in normal healthy volunteers and special patient populations.

Speaker

CEO, Early Clinical Development, WCCT Global

Jon Rojas has twenty years of clinical research experience and has conducted over 1500 trials in the clinical research industry. Since 2008, Mr. Rojas has overseen all early clinical development operations at WCCT Global, managing two early phase clinical pharmacology units with over 200 beds combined. Before his role at WCCT, Mr. Rojas has served as Sr. Vice President of Clinical Services & Support at a leading Electronic Data Capture (EDC) software development company, where he managed global teams that designed, implemented and supported all of the clinical trial management EDC systems, and was responsible for expanding global project management. Prior to this, Mr. Rojas served as the Executive Director of Clinical Operations at a 500+ bed clinical research unit with 700+ employees. Beyond clinical operations, Mr. Rojas implemented project management, clinical trial management, clinical trial monitoring, SOP and training functions. Mr. Rojas was also the clinical operations manager of a 50-bed QTc specialty unit that performed over 100 QTc trials. Mr. Rojas has delivered a multitude of educational presentations at key industry meetings such as DIA, EDC & Beyond and ACRP.

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