eShowcase: eCTDXPress Aspire
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
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
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.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.
