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What is VACAVA Regulatory Document Management System?

VACAVA provides innovative healthcare solutions that simplify the management of regulatory documents for clinical trials while also lowering associated costs. Manual workflows often result in delays and the potential loss of crucial information during document transfers, which can hinder progress. By adopting VACAVA's solutions, regulatory processes can be significantly improved through the centralization of profiles, forms, and documents on a single, user-friendly online platform. The system facilitates smooth document transitions with electronic approvals that comply with 21 CFR Part 11, ensuring that all workflows are efficient and seamless. With intuitive dashboards, oversight and management become straightforward and effective. Collaboratively developed with a prominent clinical trial research organization, VACAVA's Regulatory Document Management System is specifically engineered to enhance operations and markedly increase efficiency. Notably, it remains remarkably cost-effective and customizable to meet diverse organizational needs. VACAVA’s solutions are also scalable and delivered via the cloud, which alleviates concerns related to server management, security, and data backups, allowing organizations to concentrate on their research endeavors rather than technical challenges. Ultimately, this allows teams to operate more effectively while focusing on their core mission of advancing clinical research.

What is CIMS Global?

CIMS Global offers cutting-edge data science platforms and eClinical solutions aimed at revolutionizing the clinical trial landscape by improving the quality, efficiency, and speed of key processes such as data collection, analysis, monitoring, and regulatory submissions. Their suite of innovative tools includes CRE, DDM, DMC-HUB, and eBinder, along with a complete eClinical Suite designed to support data gathering, analytics, and clinical operations throughout every stage of a trial. Specifically, CRE functions as a multi-tenant, validated Statistical Computing Environment tailored for compliant clinical data analysis, utilizing R, RShiny, and the RStudio IDE within a secure audit-ready framework that complies with 21 CFR Part 11 and GxP regulations. DDM emerges as a patented Dynamic Data Monitoring platform that provides visual insights into cumulative treatment effects through a trial radar screen while also predicting the likelihood of trial success or failure. Moreover, the seamless integration of these advanced solutions not only reinforces CIMS Global's leading position in clinical trial technology but also empowers researchers to attain the best possible outcomes in their studies. This commitment to innovation ensures that every aspect of clinical trial management is streamlined and data-driven.

Media

No images available

Media

Integrations Supported

R
RStudio

Integrations Supported

R
RStudio

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

VACAVA

Date Founded

1996

Company Location

United States

Company Website

www.vacava.com

Company Facts

Organization Name

CIMS Global

Date Founded

2004

Company Location

United States

Company Website

cims-global.com

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

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

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

Data Science

Access Control
Advanced Modeling
Audit Logs
Data Discovery
Data Ingestion
Data Preparation
Data Visualization
Model Deployment
Reports

Electronic Data Capture

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

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