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Ratings and Reviews 0 Ratings
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What is SlimEDC?
SlimEDC offers a cloud-based platform specifically tailored for Electronic Data Collection (EDC), facilitating the efficient launch of both retrospective and prospective studies, which encompass patient studies (ePRO) and market research initiatives, all through an intuitive study editor. Users have the option to select a fully managed software service supervised by the research sponsor or a more hands-on approach where a dedicated SlimEDC team oversees the entire project, leading up to data analysis. Designed with adherence to EU regulations and standards in mind, SlimEDC actively engages respondents electronically while the platform automatically produces all requisite reports as required by regulatory agencies. Moreover, SlimEDC upholds ISO 9001 and 27001 certifications, underscoring its unwavering dedication to quality and security. Our team is not only certified by BHBIA but has also undergone specialized pharmacovigilance training to further bolster our proficiency. In addition, rigorous GDPR audits performed by independent organizations ensure that our legal and data security protocols adhere to the highest standards, safeguarding sensitive information throughout the research journey. By emphasizing both regulatory compliance and an exceptional user experience, SlimEDC establishes itself as a trusted ally in the field of electronic data collection, ultimately enhancing the quality and integrity of research outcomes. This commitment to excellence positions SlimEDC as a leader in innovation and reliability within the industry.
What is Ennov Pharmacovigilance Suite?
Ennov's Pharmacovigilance Suite provides a robust solution for the collection, management, assessment, and reporting of adverse events across both human and veterinary sectors, all housed within a unified database. The suite features advanced tools for signal detection and data analysis, ensuring compliance with international regulatory requirements. Key elements include optimized case intake and triage functionalities, improved user interfaces for data entry, customizable case input forms, and a wide array of searchable vocabulary lists. It supports multiple reporting formats, facilitating both paper and electronic submissions that adhere to CIOMS guidelines, MedWatch 3500s, and ICH E2B standards (R2 and R3). For signal detection and management, the platform provides comprehensive data querying capabilities, powerful analytical tools, and the ability to calculate important statistical metrics like PRR, ROR, and MGPS. Fully web-based and designed for ease of use, it complies with the standards set forth in 21 CFR Part 11, which ensures data integrity and security. Additionally, its flexible design allows it to cater to organizations of varying sizes, enabling users to adeptly manage the intricate landscape of pharmacovigilance while remaining responsive to evolving industry demands. This adaptability ensures that as organizations grow or change, the system remains a reliable resource throughout their pharmacovigilance journey.
Integrations Supported
Additional information not provided
Integrations Supported
Additional information not provided
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Altamira
Date Founded
2009
Company Location
Slovakia
Company Website
www.altamira.ai/slimedc/
Company Facts
Organization Name
Ennov
Date Founded
1999
Company Location
France
Company Website
en.ennov.com/solutions/pharmacovigilance/
Categories and Features
Electronic Data Capture
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management