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Description
SafetyEasy by EXTEDO is a robust software solution for managing pharmacovigilance and multivigilance, aimed at simplifying the handling of safety cases and vigilance information. It adheres to a wide range of drug safety regulations such as E2B(R3) and HL7 eMDR, while facilitating the necessary creation of regulatory documents including PSUR, PBRER, and DSUR. The software is equipped with features that optimize workflows through email alerts and online dashboards, allowing users to efficiently monitor project progress and adhere to submission timelines. Additionally, SafetyEasy features sophisticated tools like CasEasy AI, which leverages Natural Language Processing to streamline the automation of case creation, alongside a Business Intelligence module that offers an insightful 360° perspective on scientific data, thereby improving case evaluation and safety signal identification. This cloud-based platform is not only quick to deploy but also designed for ease of use, requiring very little training for effective operation. Furthermore, the integration of these advanced functionalities makes SafetyEasy an invaluable asset for organizations aiming to enhance their pharmacovigilance processes.
Description
SlimEDC serves as a cloud-based solution for Electronic Data Collection (EDC), enabling the seamless initiation of both retrospective and prospective studies, including patient studies (ePRO) and market research projects, through its user-friendly study editor. Users can choose between a fully managed software option overseen by the research sponsor or a more comprehensive service where a dedicated team from SlimEDC manages the entire process, culminating in data evaluation. Specifically designed to comply with EU regulations and standards, SlimEDC ensures that respondents are engaged electronically while the software automatically generates all necessary reports mandated by regulatory bodies. Additionally, SlimEDC maintains compliance with ISO 9001 and 27001 standards, highlighting its commitment to quality and security. Our team is certified by BHBIA and has completed specialized training in pharmacovigilance to enhance our expertise. Furthermore, strict GDPR audits conducted by independent entities guarantee that our legal and data security measures meet the highest standards, ensuring the protection of sensitive information throughout the research process. By prioritizing both compliance and user experience, SlimEDC positions itself as a reliable partner in the realm of electronic data collection.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
EXTEDO
Founded
2003
Country
Germany
Website
www.extedo.com/software/pharmacovigilance-and-drug-safety
Vendor Details
Company Name
Altamira
Founded
2009
Country
Slovakia
Website
www.altamira.ai/slimedc/
Product Features
Product Features
Electronic Data Capture
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management