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features
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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.

Description

The Records Disposition Approval Module is a vital addition for managing records within the OpenText Content Suite. This product feature is designed specifically for OpenText Content Server users, ensuring that the record approval process is streamlined and efficient. RDA was developed based on feedback from users like you, aiming to simplify the sign-off workflow and minimize the time record managers need to process approvals. It enables approvers to access all necessary metadata for each object, facilitating quick decision-making. Additionally, RDA offers various filters and facets that help users easily identify groups of records, allowing for batch approvals or rejections. For those uncertain about specific records, the module provides an option to request feedback for clarification. Users can effortlessly select approved records while deselecting those that are rejected during a disposition search, and they can also bulk apply holds or update records management metadata directly through the RDA interface. Ultimately, this module enhances both user experience and operational efficiency in records management.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

No images available

Screenshots View All

Integrations

Content Suite Security and Productivity Pack No 

Integrations

Content Suite Security and Productivity Pack Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial Yes 
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 Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

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

Customer Support

Business Hours Yes 
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 Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

OpenText

Founded

1991

Country

Canada

Website

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

Vendor Details

Company Name

Cassia Content Management

Founded

2011

Country

Canada

Website

www.cassiacm.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

Data Governance

Access Control Yes 
Data Discovery Yes 
Data Mapping No 
Data Profiling No 
Deletion Management Yes 
Email Management No 
Policy Management Yes 
Process Management Yes 
Roles Management Yes 
Storage Management No 

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