Are staff being optimized in your Phase 1 clinical trials?

Oftentimes, larger Phase 1 clinical trials will require research sites to take a unique approach to study conduct, particularly when it comes to optimizing staff in a manner that is best suited to an efficiently-run Phase 1 program. When there are a large number of volunteers involved in the study, as well as stringent protocol requirements, staff optimization can be a difficult task to accomplish.

High-performing Phase 1 units will be able to strike a balance between the need for efficiency in trial conduct and maintaining a level of quality and safety that is appropriate for a research setting. Larger cohorts can result in greater efficiencies, but increase the risk of deviations and errors due to burdened staff and congestion. Smaller cohorts can create more risk-free environments but result in fewer efficiencies for sponsors and thus, higher costs.

The following case study will highlight one of WCCT Global’s recent Phase 1 clinical trials, in which they were tasked with accelerating timelines for the sponsor, while utilizing staff in the most efficient manner possible and keeping the risk of errors and deviations to a minimum. The device study was complex in that there was a large emphasis on device performance endpoints (complex timing, delivery, adhesion, positioning), and it required a comprehensive assessment of administration sites, as well as extensive standardized photography, prior to, during, and post device delivery.

WCCT was able to develop and implement such a study at their Phase 1 clinical unit in Cypress, CA. In addition to maintaining the sponsor’s timeline and cost requirements, WCCT was able to ensure safe study conduct by using the same experienced team throughout the duration of the trial.

WCCT Global is a full service strategic development partner. Since 1998, WCCT has conducted well over 500 Phase 1 clinical trials at its corporate-owned Phase 1 unit in Cypress, CA, with experience in conducting large volume studies requiring over 200 patients. WCCT is the industry leader in Japanese bridging and has recognized expertise in multiple therapeutic areas, including Ophthalmology, Gastroenterology, Vaccines, and Influenza.

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Case study on optimizing staff in larger Phase 1 clinical trials.