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Products : HPR : SS : Electronic Study Submissions
Electronic Study Submissions
Regulatory agencies are rapidly moving toward requiring submissions in electronic format and in many instances are currently requiring electronic submissions. Electronic submissions allow regulatory reviewers to rapidly and efficiently search and navigate marketing applications and other submissions, facilitating and potentially shortening the time to approval. Data can be readily accessed, allowing reviewers to run additional analyses without having to request these analyses from the sponsor. Large paper submissions, comprising hundreds of binders and requiring extreme shipping methods, will no longer be necessary in many countries.
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ESS Solution: (ES2)
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MedChannels’s ES2 module, together with the SafetyNET adverse event tracking and reporting system, provides a comprehensive solution for safety data collection, management and submission. The ES2 module streamlines the exchange of electronic case safety information with regulatory agencies, affiliate offices and trading partners. Version 1.7 of the ES2 product is designed to adhere to the FDA's latest Electronic Submission Gateway (ESG) standards, taking advantage of ESG’s new features while offering expanded submissions tracking and acknowledgements via integration with the SafetyNET product, and enhanced application security.
The ES2 allows SafetyNET system users to improve the efficiency of electronic Individual Case Safety Report (ICSR) submissions while maintaining existing workflows. From an ES2-enhanced system, users can more easily monitor the process of both traditional paper-based reporting and electronic safety reporting.
New Features of ES2 1.7:
· Expanded submissions tracking and acknowledgements functionality
· Designed to comply with the FDA's latest AS2 ESG submission standards
· Designed to comply with submission standards for regulatory agencies in Europe and Japan
· Enhanced application security and digital certificate support
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