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
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.