eShowcase: ISI Solutions Platform
Regulatory solution suite from ISI migrates to new platform for improved integration
Regulatory solution suite from ISI migrates to new platform for improved integration
Image Solutions Inc. (Whippany, NJ) has migrated its regulatory product suite for the life sciences industry into the ISI Solutions Platform built on Microsoft's .NET Framework. By moving to the .NET Framework, companies will have one integrated platform from which to manage, review, and publish electronic submissions to the FDA.
The ISI Solutions Platform provides the technology foundation for the company's full suite of products. Its regulatory suite includes its flagship submission products, eCTDXPress and ISIPublisher. These products address the file preparation time in the submissions process. Additional productivity tools and templates are also included in the ISI Solutions Platform.
The .NET Framework gives the suite interoperability with other systems within and outside the company, including document management systems. It also features flexibility, solutions that can be easily scaled to the size of the organization, and common interfaces.
ISI, (973) 560-0404, www.imagesolutions.com
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.
