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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

Clinevo's electronic Trial Master File (eTMF) is a user-friendly digital solution for the organization and storage of documents, images, and various digital assets related to clinical trials. This eTMF incorporates an integrated DIA reference model and complies with regulatory standards. Additionally, Clinevo offers the MICC Intake, a web-based platform designed for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) professionals to efficiently log, track, and monitor Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Furthermore, Clinevo Safety serves as a comprehensive cloud-based system that ensures ease of use and regulatory compliance throughout the entire Pharmacovigilance process, encompassing PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals, all within a single platform. Lastly, the Clinevo Website Intake tool can seamlessly integrate with Sponsor or CRO websites, offering consumers and reporters an intuitive web interface for easy access and reporting. This innovative suite of tools enhances the efficiency and effectiveness of clinical trial management and safety reporting.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

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 Yes 
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 No 
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

Clario

Country

United States

Website

clario.com/solutions/ecoa/

Vendor Details

Company Name

Clinevo

Country

United States

Website

www.clinevotech.com

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Alternatives

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