Average Ratings 58 Ratings

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Description

Complex eClinical Solutions for EDC/ERT/eCOA significantly speeds up the start and completion of clinical trials (up to 5 days), reduces costs (up to 80% for monitoring), and increases capitalization and attractiveness (recognized by 89% customers). 96% of data science specialists say it increases the knowledge and advancements of Data Management and Data Science professionals. 94% of investigators love interfaces' usability. Strong internal competence in Data Management 365 is an important part of the Data Management 365 policy. This allows us to not only better understand the challenges faced by Data Managers and improve the MainEDC™, but also to transfer technology and best practices to our clients.

Description

In recent years, the Life Sciences sector has incurred nearly $15 billion in fines and settlements related to compliance, underscoring the importance for firms to follow best practices in pharmaceuticals, medical devices, and biotechnology. Additionally, the way clinical trials are managed can greatly influence the timeline, scope, and financial resources allocated for the development of drugs or medical devices. Utilizing OpenText™ Clinical Trial Quality Management System (ctQMS) allows organizations to maintain compliance, lower record management expenses, and foster collaboration to implement best practices throughout the entire clinical trial lifecycle. This strategic approach not only enhances operational efficiency but also contributes to the overall success of product development initiatives.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

Flex Databases Yes 

Integrations

Flex Databases No 

Pricing Details

$399.00/month
Please see our web-site
Free Trial Yes 
Free Version Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App No 
Android App Yes 
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) Yes 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Data Management 365

Founded

2015

Country

United States

Website

datamanagement365.com

Vendor Details

Company Name

OpenText

Founded

1991

Country

Canada

Website

www.opentext.com/info/clinical-trial-management

Product Features

Clinical Trial Management

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

Electronic Data Capture

Audit Trail Yes 
CRF Tracking Yes 
Data Entry Yes 
Data Verification Yes 
Distributed Capture Yes 
Document Imaging Yes 
Document Indexing No 
Forms Management Yes 
Remote Capture Yes 
Study Management Yes 

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

Alternatives

Medidata Reviews

Medidata

Dassault Systèmes