Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
BrightInsight significantly shortens the time it takes for clients to bring their digital health solutions to market, which encompasses apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD) across various therapeutic domains. By utilizing a pre-built and validated digital health platform that adheres to a comprehensive Quality Management System, BrightInsight eliminates the need for time-consuming and complex custom implementations while ensuring compliance with global security, privacy, and regulatory standards. For example, we assisted Roche in launching a Software as a Medical Device (SaMD) dosing calculator for hemophilia A in just six months in Europe, and we expedited a remote patient platform for a Top 10 Biopharma company from the initial project kickoff to market readiness in under a year. Our expertise lies in the development and maintenance of regulated digital health products for both the biopharma and medtech sectors, having achieved multiple successful commercial launches within the past year alone. This proficiency enables us to respond swiftly to industry demands while maintaining the highest standards of quality and compliance.
Description
Sapling Data's Compliance Cloud provides automated compliance monitoring for medical device and pharmaceutical companies. The Compliance Cloud allows you to create a single source for truth that integrates data from multiple data sources. It provides intelligent insights to monitor and detect compliance issues and alerts you to critical issues. You can perform investigations with the integrated data and build dashboards for presenting the results. The Compliance Cloud comes with updated government Sunshine data allowing you to compare your compliance to other companies and prepare for Sunshine reporting.
API Access
Has API
No
API Access
Has API
Yes
Integrations
SAP Concur
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
BrightInsight
Founded
2017
Country
United States
Website
brightinsight.com
Vendor Details
Company Name
Sapling Data
Founded
2013
Country
United States
Website
saplingdata.com/compliance
Product Features
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
No
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
No
Healthcare CRM
Audience Targeting
Yes
Campaign Management
Yes
Marketing Automation
No
Medical History Records
Yes
Patient Communications
Yes
Patient Management
Yes
Physician Management
Yes
Predictive Analytics
Yes
IoT
Application Development
No
Big Data Analytics
Yes
Configuration Management
Yes
Connectivity Management
Yes
Data Collection
No
Data Management
Yes
Device Management
Yes
Performance Management
No
Prototyping
No
Visualization
No