A major pharmaceutical support company was contracted to provide clinical trial nursing services in a pivotal Phase III rare disease trial. As this indication affects less than 2% of the population, ensuring that enrolled patients completed study requirements without loss-to-follow up was crucial. The study was designed to assess the efficacy and safety of the study drug compared with placebo in adults who had been receiving the study drug via a separate open label trial.
Patients enrolled in the open label trial who consented to be enrolled in the Phase III trial were flown to one of two locations and housed at a hotel in close proximity to the study site. The protocol required a separate nurse (outside of the study site) to visit the patient and provide an overview of the study requirements, obtain lab samples and check on the overall health of the patient outside of site visits. Additionally, the designated hotel was to provide 24/7 supplementary emergency health care services.
SMO Group can offer all these services and more in a comprehensive patient centric program.