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Description
OpenSourcePV, established by Lionel Van Holle in 2019, aims to leverage free and open-source technologies to enhance pharmacovigilance standards and offer a cost-effective alternative to costly specialized software in this field. Pharmaceutical companies are required to monitor the safety of their products to meet regulatory requirements, but as they expand their product lines and pipelines, the volume of data that needs to be analyzed quickly becomes overwhelming for manual review. Currently, they face a dilemma: invest in an expensive software suite or attempt to develop a solution in-house. OpenSourcePV supports these companies in their journey towards effective quantitative signal detection by providing access to pre-built modules while also enabling customization to fit their unique requirements and data sources. This flexibility allows them to efficiently handle large datasets and improve their overall 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
Free
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
OpenSourcePV
Founded
2019
Country
United States
Website
www.opensourcepv.com
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