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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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

cubeSAFETY is an advanced pharmacovigilance platform designed to assist safety teams in efficiently managing adverse-event reporting, regulatory submissions, and case processing in a compliant manner. It adheres to ICH E2B and various regional reporting standards, facilitating submissions to agencies like the FDA, EMA, CDE, MFDS, and PMDA through specialized gateways, while also automatically converting and formatting data for CIOMS and XML export. The platform boasts AI-driven medical coding suggestions, duplication detection, the capability to import CIOMS PDF files, and dynamic dashboards for real-time submission tracking. Additionally, it offers complete integration with other CRScube modules, including cubeCDMS. cubeSAFETY is crafted to enhance the safety-case entry process, guarantee superior data quality through embedded validation features, and streamline workflows for compliance with global regulatory requirements, all while decreasing manual labor and financial overhead. Ultimately, this innovative platform aims to redefine pharmacovigilance efficiency and accuracy across the industry.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

XML
cubeCDMS
cubeCTMS

Integrations

XML
cubeCDMS
cubeCTMS

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

CRScube

Founded

2010

Country

South Korea

Website

www.crscube.io/solution/cubesafety

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

Product Features

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