Custom Solutions for Site-specific Issues

Create effective, site-specific solutions for operational, clinical, and quality issues arising within a pharmacy, enhancing sponsor credibility and support of trial sites.

Without in-depth knowledge of pharmacy workflows, it is hard to understand how all the pieces fit together and why recurring deviations are occurring at a unique site. It is in the sponsor’s interest to understand and address the site pharmacy because it usually means a study request may be out of alignment with the pharmacy’s SOP or resources. This puts the sponsor at a disadvantage resulting in multiple email exchanges and wasted resources on both sides. A pharmacy SME who knows pharmacy standards can provide alternative solutions to effectively resolve the problem. This gives the sponsor credibility and efficiency especially when applied to multiple studies of the same drug.