ERT assisted a mid-sized pharmaceutical company running Phase II and III studies for a compound to treat hypophosphatemia, a rare genetic disorder, by providing cardiac imaging and echocardiography services.
Why Cardiovascular Imaging was Essential to the Study
The sponsor was running six studies for a compound to treat the rare genetic disorder hypophosphatemia, spanning more than 40 global study sites. The compound being tested had the potential to cause adverse cardiovascular effects.
For their studies, the sponsor required a partner that could monitor for these cardiovascular effects with the highest possible degree of accuracy and consistency. Additionally, the sponsor sought a partner that could improve their study experiences in general, as previous locally performed studies had not met the sponsor’s needs.
ERT developed and utilized a precisely controlled and tailored imaging protocol designed to assure a high degree of measurement accuracy and reproducibility, along with operational and scientific support from a collaborative, high-touch team approach that provided the sponsor with access to ERT cardiologists and imaging experts throughout the course of these studies.
ERT’s Cardiac Imaging Solution
By working with ERT, the sponsor was able to:
- Successfully managed six studies involving 40+ sites spanning several countries
- Rescue and realize the value of data produced in previous studies that would have otherwise been unusable
- Report consistent and reproducible results
- Perform 1,600+ echocardiogram reads with a high degree of measurement accuracy and consistency
- Report zero significant compound-related patient indications of ectopic mineralization, general hypertrophy and hypertrophic cardiomyopathy
- Report zero significant compound-related patients indications related to LV mass
- Support treatment safety and efficacy claims through high-quality data and accurate imaging measurements