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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

Koneksa stands out as a prominent digital biomarker firm catering to the pharmaceutical and biotechnology sectors, focusing on the creation, testing, and validation of digital biomarkers that assist clients in assessing how treatments affect patients. Established in 2013, Koneksa delivers comprehensive remote clinical trial support by integrating digital health technologies, therapeutic knowledge, and swift, user-friendly remote data gathering to enhance understanding of patient health outcomes. Their innovative and validated data algorithms are designed for immediate use in treatment development initiatives, facilitating the detection of signals more rapidly than conventional methods. The company's cloud-based Software as a Service (SaaS) platform enables real-time integration of multiple endpoints, providing instant access to data and supporting informed, cost-effective decision-making early in the trial process. Additionally, this platform’s capability to gather extensive remote data at higher frequencies presents opportunities for obtaining ecologically valid measures, which can lead to a reduction in sample size while maintaining the integrity of the research. By continuously evolving their tools and methodologies, Koneksa aims to redefine how clinical trials are conducted in the modern age.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

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

Koneksa

Founded

2013

Country

United States

Website

www.koneksahealth.com

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

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