Case Study

A Global Observational Registry Of Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH)

patient and doctor medical healthcare

For more than 6 years, UBC has been conducting a long-term global product exposure registry for patients with homozygous familial hypercholesterolemia (HoFH). Our responsibilities include registry design, program management, site regulatory approval (central and local), site management, data collection and management, statistical analysis, and medical writing with annual reporting to regulatory agencies. Previous challenges included delays with the reimbursement process in several countries had a measurable impact on site selection, overall recruitment, site engagement, and costs. Interested sites often had to be put on hold. Data collection is based on medical record review at specified intervals, rather than at each patient’s usual care visits. Read how UBC efficiently and strategically manages the registry with rolling start-up, including mandated annual data collection and reporting.

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