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What is RIMExpert?

RIMExpert™ significantly optimizes regulatory planning, tracking, and data management by managing global rollout strategies and automating the preparation of regulatory submissions, activities, and medicinal products. By reducing the need for extensive data entry, RIMExpert™ improves data integrity and increases global oversight and control. The platform standardizes processes involved in regulatory planning, tracking, and registration management, which enhances collaboration between headquarters and their affiliates. It creates a centralized hub for all activities related to registrations, allowing for a single access point that gathers inquiries, commitments, correspondence, and authorizations for each application, thus aligning efforts to maximize efficiency in regulatory resources across the enterprise. Moreover, RIMExpert™ provides meticulous oversight of registration activities throughout the entire product lifecycle, ensuring that timelines, commitments, and agency inquiries are consistently monitored. It includes interactive dashboards that deliver a holistic view of regulatory actions and registrations, equipping teams with the insights needed for informed decision-making and prompt responses. By doing so, RIMExpert™ not only fortifies regulatory compliance but also enhances the overall effectiveness of the organization, paving the way for improved operational success. This comprehensive approach ultimately strengthens the framework within which regulatory processes are managed and executed.

What is OpenText for Life Sciences?

OpenText™ Information Management solutions provide life sciences organizations with the tools needed to leverage data and content insights, improving their decision-making processes and accelerating product development timelines. These solutions facilitate the smooth integration, management, and secure exchange of information across individuals, systems, and devices. By optimizing the use of information assets from research and development to commercialization, companies can take advantage of flexible cloud-native software that functions seamlessly in various environments. OpenText specifically tailored for the life sciences sector greatly speeds up the discovery phase, enabling the extraction of actionable insights that drive innovation throughout the development pipeline. Users can transform research articles into electronic lab notebooks via intelligent capture and harness text mining techniques to reveal valuable insights. Furthermore, the platform excels in extracting knowledge from unstructured text found in clinical trial reports, study protocols, and data pertaining to clinical safety and efficiency. It also provides tools for the intelligent analysis, categorization, and extraction of information from clinical trial documents, thereby reducing the likelihood of costly delays and disruptions in the development process. By harnessing these advanced features, life sciences organizations can significantly improve their operational efficiency and propel their research initiatives forward while remaining competitive in a fast-evolving field. The integration of these tools ultimately enhances collaboration and innovation across the entire organization.

Media

Media

Integrations Supported

Amazon Web Services (AWS)
Google Cloud Platform
Microsoft 365
Oracle Cloud Infrastructure
SAP Cloud Platform
SAP HANA
SAP S/4HANA
Salesforce

Integrations Supported

Amazon Web Services (AWS)
Google Cloud Platform
Microsoft 365
Oracle Cloud Infrastructure
SAP Cloud Platform
SAP HANA
SAP S/4HANA
Salesforce

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

AMPLEXOR

Date Founded

1987

Company Location

Luxembourg

Company Website

www.amplexor.com/en/life-sciences-suite/rim/regulatory-planning-tracking.html

Company Facts

Organization Name

OpenText

Company Location

Canada

Company Website

www.opentext.com/products-and-solutions/industries/life-sciences

Categories and Features

Categories and 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

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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