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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.
Description
Veeva Vault Safety is an advanced system designed for the management of individual case safety reports, facilitating the collection, processing, and reporting of adverse events related to both clinical trials and marketed products. This comprehensive platform allows sponsors and contract research organizations (CROs) to handle both global and local adverse events for various categories, including drugs, biologics, vaccines, devices, and combination products. Its integrated gateway connections and established reporting protocols enhance the efficiency of submitting cases to regulatory authorities and sharing information with partners. Additionally, the centralized management of coding dictionaries automates updates for MedDRA, WHODrug, and EDQM on a semi-annual basis. By consolidating pharmacovigilance processes within a single cloud environment, Vault Safety promotes proactive measures in ensuring patient safety. The system also utilizes real-time reports and dashboards, coupled with seamless collaboration, to enhance visibility and ensure compliance regarding adverse event reporting. Ultimately, this innovative solution transforms the approach to safety management in the pharmaceutical industry, fostering a more efficient and effective response to patient safety concerns.
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
Altamira
Founded
2009
Country
Slovakia
Website
www.altamira.ai/slimedc/
Vendor Details
Company Name
Veeva
Country
United States
Website
www.veeva.com/products/vault-safety/
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