Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
AccelSafety is an all-encompassing pharmacovigilance solution crafted by Techsol Life Sciences, centered around the Oracle Argus Safety application, designed to streamline the unified gathering, medical evaluation, and regulatory reporting of safety surveillance data for both clinical and post-marketing purposes. This fully managed cloud-based platform empowers emerging biopharma companies, device manufacturers, and service providers to effectively handle safety data while ensuring their business decisions align with global compliance standards. Among its primary advantages are expedited Argus Safety implementation, migration, and validation that reduce effort by 70%; secure transfer of existing safety data to the AccelSafety Cloud; and enhanced case processing efficiency through tailored configurations and built-in automation. Additionally, users benefit from extensive operational insights provided by advanced reporting tools, line listings, and analytics packages, as well as round-the-clock support from the Argus Safety Service Desk for user inquiries, incident resolutions, and change management needs. Overall, AccelSafety stands out as a pivotal tool for organizations looking to optimize their pharmacovigilance processes and uphold regulatory obligations effectively.
Description
Ennov's Pharmacovigilance Suite serves as a comprehensive solution for the collection, management, assessment, and reporting of adverse events in both human and veterinary fields, all within a single database framework. It boasts sophisticated tools for signal detection and data analysis, reinforcing adherence to international regulatory standards. Notable features encompass streamlined case intake and triage processes, enhanced user interfaces for data entry, adaptable case input forms, and an extensive range of searchable vocabulary lists. The system accommodates various reporting formats, including both paper and electronic submissions, compatible with CIOMS guidelines, MedWatch 3500s, and ICH E2B standards (R2 and R3). In terms of signal detection and management, it offers extensive data querying options, robust analytical tools, and the ability to compute essential statistical measures such as PRR, ROR, and MGPS. Entirely web-based and user-friendly, the platform is built to meet the standards of 21 CFR Part 11, thereby guaranteeing the integrity and security of data. Moreover, its adaptability makes it suitable for organizations of all sizes, ensuring that users can efficiently navigate the complexities of pharmacovigilance.
API Access
Has API
No
API Access
Has API
No
Integrations
Oracle Argus
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
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Techsol Life Sciences
Founded
2010
Country
United States
Website
www.techsollifesciences.com/services/accelsafety/
Vendor Details
Company Name
Ennov
Founded
1999
Country
France
Website
en.ennov.com/solutions/pharmacovigilance/