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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 K2C PSMF Solution?

The K2C PSMF Solution introduces a groundbreaking approach to managing the Pharmacovigilance System Master File. It is crucial to periodically revise this document whenever significant changes occur in the pharmacovigilance protocols. These changes require input from multiple roles within the organization to modify a cohesive document that is structured according to regulatory guidelines. However, the process of coordinating these edits can be quite difficult, particularly because certain sections must be limited to designated editors and kept hidden from other contributors. To tackle this issue, the K2C solution treats each paragraph and annex as individual documents, making it easier to compile the final PSMF document by combining these various components. Furthermore, the K2C PSMF Solution manages contributions to the PSMF as separate entities, allowing for the control of access rights for both viewing and editing, while also providing thorough oversight of the entire document lifecycle, thereby ensuring compliance and efficiency throughout the entire process. This organized method not only improves collaboration among teams but also reinforces adherence to regulatory standards, ultimately enhancing the overall quality of the pharmacovigilance practices within the organization. As a result, the K2C PSMF Solution is an essential tool for organizations aiming to streamline their pharmacovigilance efforts.

Media

Media

Integrations Supported

Integrations Supported

Microsoft SharePoint

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

€8,500 one-time payment
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
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

K2C

Company Location

United Kingdom

Company Website

www.k2c.com/products/K2Pharma/PSMF.html

Categories and Features

Pharmacovigilance

Not specified

Categories and Features

Pharmacovigilance

Not specified

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