Over-Encapsulation of Commercial Product for Clinical Trial
The leading hospital system affiliated with a prestigious East Coast university wanted to conduct a clinical trial with a selective serotonin reuptake inhibitor. However, this institution did not have the capacity to manufacture the quantity of clinical trial material required for this study. As a strategic contract manufacturer, PGC was able to deliver the materials needed by this hospital for its study.
While this thought-leading institution had designed a clinical trial and secured funding for this study, it could not manufacture the drug in ample quantities required by its plan and in a timely manner, as the only material was manufactured internationally. Moreover, the hospital wanted its study to be double-blinded to maximize clinical findings in a scientific manner, requiring a respective placebo to the active comparator in ample quantities to use. However, due to the shape of the active drug, developing a corresponding placebo was challenging in a cost-effective manner.
PGC worked with the CRO to develop a work plan to supply initial study quantities and additional kits, as needed. The devised logistics for placing the specific drug products (active or placebo) in the appropriate compartments proved to be an advantage in completing the project quickly. Quality assurance was integrally involved with the assembly process by overseeing the ongoing process and ensuring that the clinical packaging and labeling for the finished kits were correct as designed, accurately labeled, and sealed appropriately.
First, PGC initiated contact to source the active drug, negotiating the purchasing terms on behalf of the hospital. Upon receipt of the commercial product, PGC determined that over-encapsulation would be the optimal path to provide materials for this study. Furthermore, PGC was able to formulate a respective placebo and manufacture it in ample quantities to use. Additionally, PGC supplied the finished product in bulk packaging, as requested. Through PGC's collaborative effort, the institution was able to secure all the materials required to complete the double-blinded study as written in the grant proposal and meet their budget.