Implementing a Cloud-based eCTD Solution
Apr25

Implementing a Cloud-based eCTD Solution

Cloud technology considerations should not be restricted to your organization’s IT professionals any longer. Business owners must take an active role in understanding the technology and its potential impact. Deliberations on adoption of an in-house system deployment versus cloud-managed systems center on initial implementation and ongoing maintenance. Additional points to weigh include resource support and the value of your...

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eCTD Cloud Vendor Selection Q&A

GlobalSubmit recently held an educational webinar entitled Regulatory and the Cloud Vendor Selection. Software as a service (SaaS, typically pronounced [sæs]), often referred to as “cloud technology” or “on-demand software,” is a software delivery model in which software and its associated data are hosted centrally, typically in the Internet. The combination of ever-more-abundant bandwidth, increasingly powerful...

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Impact of the FDA’s eCTD Mandate

With the FDA Safety & Innovation Act now signed into law, life science companies will need to start thinking strategically about the impact of the FDA’s eCTD mandate and how to quickly and easily comply. Since most of the larger companies already submit electronically, the greatest impact will be to the smaller, virtual companies that do not have substantial IT infrastructure in place, and lack the overall budgetary...

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U.S. Department of Defense Promotes Security Benefits of the Cloud

We have all heard of the high profile security breaches at the U.S. Department of Defense in the last few years — from state sponsored hackers stealing nearly 25,000 files related to new weapon systems to an army soldier providing secret documents to WikiLeaks, among others. The fact that those breaches occurred on supposedly secure systems that DOD and its industry partners have operated for years shows just how challenging...

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Globalization, Resource Constraints Top List of Regulatory Operations Concerns

On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference speakers included a number of experienced directors and senior directors of regulatory affairs/reg operations from medium and large Pharma companies. During a panel discussion, an excellent question was posed: What are your biggest challenges – what keeps you up at night? Although we received four different answers from the panelists, they all had a...

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