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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 Signant Health?

Signant Health stands as a global frontrunner in evidence generation, dedicated to revolutionizing the clinical trial landscape by engaging patients in their own settings and reimagining the path to validation. They provide a comprehensive suite of clinical technology solutions that encompasses electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician evaluations, and an integrated eClinical platform. Their offerings also include patient engagement tools like an intuitive app, eConsent for effective informed consent practices, and telehealth capabilities. Furthermore, Signant Health specializes in clinical data and analytics services, which involve COA data analysis along with the synthesis and interpretation of data. With over thirty years of experience, the company has been crucial in facilitating numerous clinical trials and has significantly contributed to hundreds of drug approvals, solidifying their position as a dependable partner for sponsors and CROs who aim to deliver high-quality data for informed decision-making and regulatory filing. Their unwavering dedication to innovation is continuously molding the future of clinical research, ensuring that advancements benefit both patients and the medical community at large.

Media

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Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

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

Signant Health

Company Location

United States

Company Website

signanthealth.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

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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