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features
design
support

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Write a Review

Description

Clindata Cloud gathers pre-clinical, clinical, and Risk Metric data from various sources and provides the clinical operations teams with data sets that are ready for submission, along with analytics and alerts for risk-based monitoring. It integrates and harmonizes study data from different origins into a unified data model, ensuring that the incoming data is validated for factors such as completeness, accuracy, integrity, and consistency while also raising alerts for any anomalies or risk indicators. Data is standardized according to CDISC data standards to reduce noise and facilitate the creation of ready-to-submit data sets in real-time, allowing for ongoing validation and analysis. Additionally, it produces real-time analytics based on the standardized data, ensuring timely insights for clinical decision-making. This comprehensive approach enhances the efficiency and reliability of clinical operations.

Description

RegDocs Connect equips both operational and regulatory teams with essential tools for creating thorough and compliant documents and records that are ready for submission. Designed with the end user's experience in mind, this solution prioritizes collaboration, automation, and quality as its core principles. Automated workflows streamline the management of the records lifecycle from the initial draft to the final version, allowing your team to maintain full oversight of regulatory documents at all times. By aligning document types with the EDM reference model and eCTD, this system enhances the organization and retrieval of documents necessary for regulatory submissions. Additionally, proprietary features such as PDF/A Publishing, document classification, and distinctive document identifiers create a robust regulatory document management framework that consolidates information from various parts of your organization into a single, navigable solution. As electronic submissions to regulatory bodies become more prevalent and the intricacies of drug development increase, the capacity to generate high-quality, submission-ready content is more critical than ever, ensuring compliance and efficiency in the regulatory process. Moreover, this comprehensive approach not only simplifies the documentation process but also fosters greater collaboration among teams, ultimately leading to improved outcomes in regulatory affairs.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Montrium Connect No 

Integrations

Montrium Connect Yes 

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

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 Yes 

Vendor Details

Company Name

Clinical Data

Website

www.clindatainc.com

Vendor Details

Company Name

Montrium

Country

Canada

Website

www.montrium.com

Product Features

Clinical Trial Management

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

Product Features

Document Management

Access Controls No 
Archiving & Retention No 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing No 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion Yes 
Forms Management No 
Full Text Search No 
Offline Access No 
Optical Character Recognition No 
Print Management No 
Version Control Yes 

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