Veeva and Bioforum Partner with RedHill Biopharma on Phase II/III COVID-19 Data
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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
The Role of Human Oversight With Artificial Intelligence in Clinical Research
April 12th 2024In the fifth and final part of this video interview with ACT editor Andy Studna, Stephen Pyke, chief clinical data and digital officer, Parexel, highlights the importance of human oversight when using artificial intelligence to aid in decision making.
