Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Essenvia enhances business value and improves operational efficiency across various teams and departments. It serves as a centralized hub for all regulatory data, facilitating collaborative document creation and reporting while helping to prevent technical holds, RTAs, and RFIs. This platform empowers the regulatory affairs team to speed up product launches, thus avoiding revenue losses associated with submission delays and missed renewals. It provides a comprehensive overview of the entire regulatory lifecycle, complete with executive dashboards, key performance indicators, and proactive alerts for global registrations, submissions, and change assessments. Essenvia acts as a Regulatory Information Management (RIM) Platform that streamlines regulatory workflows throughout the entire product lifecycle, enabling faster global market access and delivering significant business advantages. By consolidating all regulatory activities into one unified platform, businesses can accelerate their market entry. Additionally, it includes a central repository for all registration documents, which are linked to product master data, allowing users to effectively manage the product registration lifecycle on a country-by-country basis while ensuring compliance and efficiency.
Description
Flatiron Health's Evidence Solutions provide a versatile method for generating real-world evidence, both prospective and retrospective, which aids life sciences companies in efficiently meeting their oncology research objectives. At the heart of these offerings is Flatiron Horizon, a comprehensive platform that combines a rich database of more than 5 million anonymized patient records and 1.5 billion data points, coupled with advanced curation techniques and disease-specific machine learning models. This innovative platform is designed to facilitate various phases of the biopharma lifecycle, including discovery, clinical study design, regulatory submissions, and post-marketing commitments. Furthermore, Flatiron's services deliver customized real-world data configurations that cater specifically to oncology, enabling prospective evidence generation through minimally invasive studies and optimizing protocols for better patient identification. Additionally, the platform ensures a streamlined transfer of data from electronic health records to electronic data capture systems with the functionality of Flatiron Clinical Pipe, enhancing overall research efficiency and effectiveness. Such capabilities position Flatiron Health as a leader in transforming oncology research through the power of real-world data.
API Access
Has API
No
API Access
Has API
No
Integrations
Arena PLM
Yes
EQMS
Yes
Oracle Fusion Cloud PLM
Yes
Qualio
Yes
Integrations
Arena PLM
No
EQMS
No
Oracle Fusion Cloud PLM
No
Qualio
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
Yes
Vendor Details
Company Name
Essenvia
Country
United States
Website
essenvia.com
Vendor Details
Company Name
Flatiron
Country
United States
Website
flatiron.com/real-world-evidence