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Veeva Systems and Bioforum have announced their collaboration with RedHill Biopharma Ltd. on a global Phase II/III clinical study evaluating opaganib, an orally-administered, sphingosine kinase-2 selective inhibitor, in patients hospitalized with severe COVID-19 pneumonia requiring treatment with supplemental oxygen.
The opaganib Phase II/III study is set to enroll up to 270 patients in up to 40 clinical sites around the world and collect broad and rigorous data in a short amount of time. To support the study, RedHill has adopted Veeva Vault CDMS, a modern cloud platform for electronic data capture (EDC), coding, data cleaning, and reporting. Vault CDMS provides RedHill with a EDC that aims to simplify processes for building and deploying clinical studies. Bioforum, a global data-focused contract research organization and a certified Veeva partner, has been selected by RedHill, a long-time client, to implement and configure Vault CDMS for this COVID-19 study.
Vault CDMS enables trial sponsors and their CRO partners to manage studies collaboratively from build through execution.
“RedHill’s opaganib is an exciting, needed drug candidate to overcome the pandemic,” said Henry Levy, general manager, Vault CDMS, sites and patients at Veeva Systems. “We’re thrilled that our technology and partnership with Bioforum are helping to drive innovation and look forward to working alongside RedHill in advancing this important treatment with the potential to save lives and improve the health of COVID-19 patients.”
Bioforum’s co-founder and president Amir Malka added, “We’re proud to be contributing to this important COVID-19 study. This continues our long-term partnership with RedHill, supporting their efforts to rapidly advance global clinical development programs and deliver therapies that make a meaningful difference in patients’ lives. We’re confident that together with Veeva, we can help clients like RedHill improve efficiencies in all stages of clinical development—from study design and start-up through execution and submission.”
Read the full release, here.