ArisGlobal, a leading provider of solutions to the life sciences industry, has announced that agDisclosure, its clinical trial disclosure solution, now supports Version 10 of the European Medicines Agencys EudraCT database
ArisGlobal, a provider of solutions to the life sciences industry, has announced that agDisclosure, its clinical trial disclosure solution, now supports Version 10 of the European Medicines Agency’s EudraCT database (European Union Drug Regulating Authorities Clinical Trials). EudraCT Version 10 makes the reporting of summary results mandatory to EudraCT, including those for legacy studies by July 2015 or July 2016, depending on the age of the trial. agDisclosure now supports reporting of results to both ClinicalTrials.gov and EudraCT, allowing customers to use ClinicalTrials.gov data and transform it to EudraCT data. agDisclosure supports the complete trial disclosure process – from gathering required data, reviews by stakeholders, conducting checks against registry-specific validation rules, to generating XML files for upload and automatic 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.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.