
- Applied Clinical Trials-10-01-2006
- Volume 0
- Issue 0
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,
Articles in this issue
about 19 years ago
Impact of EU Directive on Clinical Developmentabout 19 years ago
Assessing Safety in Clinical Trialsabout 19 years ago
eShowcase: LabPas CT 2.5about 19 years ago
Informed Consent Considerationsabout 19 years ago
eShowcase: GlobalView EventNetabout 19 years ago
Subject Protection Issues Gain Broad Supportabout 19 years ago
Data Management: R.I.P. or Brave New World?about 19 years ago
Hurricane Katrina: What Have We Learned?about 19 years ago
Broad Introduction to CTsabout 19 years ago
CDISC Standards Energize EDCNewsletter
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