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Description
Enhance the quality of your evidence with superior electronic Patient-Reported Outcomes (ePRO) and electronic Clinical Reported Outcomes (eClinRO). These Electronic Clinical Outcome Assessments, known as eCOA, evaluate patients' feelings and functionality during clinical trials effectively. By collecting clinical data in an electronic format, you can ensure that the data from your patients is not only high-quality but also in compliance with regulatory standards. In essence, eCOA eliminates the challenges related to paper diaries, such as issues with readability, transcription mistakes, and discrepancies in data. Furthermore, the FDA advocates for the use of ePRO. This involves patients providing insights into their health through various questionnaires or assessments, which may include evaluations of quality of life or activity levels. Clinician-reported outcomes, on the other hand, involve health assessments made by a clinician, with examples such as physical examinations like PASI. Additionally, performance outcomes gauge a patient's ability to complete specific tasks, such as performing a timed activity, thereby offering a comprehensive view of their health status. Ultimately, the transition to eCOA and its associated methods signifies a move towards more reliable and efficient clinical trial processes.
Description
Zelta is a cloud-powered platform for unified clinical data management and acquisition, designed to streamline and enhance clinical trial processes. Its modular architecture adapts to the unique demands of each study, enabling faster and more efficient outcomes. With capabilities such as electronic data capture, clinical operations management—including randomization and trial supply tracking—clinical trial management, and electronic trial master file functionality, Zelta supports comprehensive study oversight. It also enhances patient and provider engagement with electronic clinical outcome assessments and e-consent solutions. Built for studies across all phases, therapeutic areas, and global regions, Zelta offers an intuitive user experience with secure single sign-on access from anywhere. Its flexible and scalable design allows for seamless customization and integration with both native and third-party technologies, ensuring adaptability to diverse research needs.
API Access
Has API
API Access
Has API
Integrations
ClinVigilant
IBM Datacap
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
Clario
Country
United States
Website
clario.com/solutions/ecoa/
Vendor Details
Company Name
Merative
Founded
2022
Country
United States
Website
www.merative.com/clinical-development
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
Electronic Data Capture
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management