Regulatory submission solution addresses the needs of smaller biotech and pharma companies
Regulatory submission solution addresses the needs of smaller biotech and pharma companies
eCTDXPress Aspire
Image Solutions, Inc. (Whippany, NJ) recently released eCTDXPress Aspire, its Web-based eSubmissions software package. The electronic regulatory submissions package is targeted toward growing biotech and small pharmaceutical companies. The software enables smaller organizations the ability to create and manage submissions in-house to ensure they are correctly implemented and validated.
eCTDXPress Aspire is fully scalable, a convenient feature for companies anticipating future growth. Other features include life cycle management capability, on-site maintenance and support from Image Solutions, and the availability of ISI consultants for regulatory operations submission help—a good way for employees to gain knowledge and experience in building eCTDs in-house. The eCTDXPress Aspire package includes eCTDXPress Compiler, which helps ensure submissions are built to agency specifications, and eCTDXPress Manager, a central eCTD repository.
Image Solutions, Inc., (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.