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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
ClinAccess™ 5.1 represents the evolution of our premier Clinical Data Management System, built entirely on the robust SAS® 9 platform. This innovative system paves the way for streamlined clinical data management, efficient clinical trial analysis, and seamless preparation of electronic submissions. By integrating data entry directly into SAS® data sets, it significantly boosts your team’s efficiency by removing the cumbersome process of transferring data from Oracle/SQL to SAS. ClinAccess™ is specifically tailored for user-friendly study definition, data entry, and management, featuring tools that track the progress and quality of ongoing clinical trials. Your data is consistently maintained in SAS® for easy access, whether for review, analysis, or submission to the FDA. The underlying database architecture is optimized to facilitate rapid statistical analysis and reporting. Consequently, users can expect reduced time and effort in data analysis, ultimately leading to a faster time to market. Additionally, ClinAccess™ stands out for its reliability, comprehensive auditing capabilities, and robust security measures, making it an unparalleled choice for clinical data management. With ClinAccess™, you can confidently navigate the complexities of clinical trials while ensuring data integrity and compliance.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
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
MAJARO InfoSystems
Founded
1987
Country
United States
Website
www.majaro.com/html/clinical-data-management-software/clinaccess.html
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