GlobalSubmitCertara
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About
Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire document lifecycle and meeting your organization’s goals on expediting your release to market. With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients. As your regulatory department races to meet deadlines and deliver treatments to patients, it’s crucial that you file your eCTD submissions.
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About
Signant Health is a global evidence-generation company that helps modernize clinical trials by meeting patients where they are and reimagining the path to proof. They offer comprehensive clinical technology solutions, including electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician ratings, and a unified eClinical platform. Their patient engagement tools encompass a patient engagement app, eConsent, and telemedicine capabilities. Signant Health also provides clinical data and analytics services, such as COA data analytics and data aggregation and intelligence. With over 30 years of experience, they have supported thousands of trials and contributed to hundreds of drug approvals, making them a trusted partner for sponsors and CROs aiming to deliver high-quality data for trial decisions and regulatory submissions.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Companies seeking a solution designed to simplify complex regulatory processes
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Audience
Contract research organizations interested in a solution to enhance data collection, patient engagement, and trial management
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Support
Phone Support
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24/7 Live Support
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Online
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Support
Phone Support
Supported
24/7 Live Support
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Online
Supported
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API
Offers API
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API
Offers API
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Pricing
No information available.
Free Version
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Free Trial
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Pricing
No information available.
Free Version
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Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
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Live Online
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In Person
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Training
Documentation
Supported
Webinars
Supported
Live Online
Not Supported
In Person
Supported
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Company InformationCertara
Founded: 2008
United States
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
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Company InformationSignant Health
United States
signanthealth.com
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Integrations
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Integrations
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