VACAVA Regulatory Document Management System Description
VACAVA Healthcare Solutions reduces the complexity and costs of regulatory document management for clinical trials. Documents can be lost or delayed if they go through a manual workflow. VACAVA solutions streamline regulatory processes by storing forms, profiles, and documents in one easy-to-access online place. With electronic approvals, documents can seamlessly move through your workflow (21 CFR Part 11 compliant). Easy-to-read dashboards enable efficient management. VACAVA's Regulatory Document Management System was developed in collaboration with a major clinical research base to simplify operations, and dramatically increase efficiency. VACAVA's Regulatory Document Management System can be tailored to your specific needs. It is surprisingly affordable. VACAVA's solutions can be customized to meet your unique needs. They are flexible and scalable and delivered via cloud so that you don't have to worry about security and backups.
VACAVA Regulatory Document Management System Alternatives
Veeva SiteVault
Streamline regulatory operations within your organization to improve compliance. Veeva SiteVault simplifies clinical trial management by connecting all regulatory operations. This improves efficiency and compliance. A single system that integrates regulatory and source documents supports 21 CFR Part 11 compliance and HIPAA requirements. SiteVault Enterprise provides real-time visibility across trials and speeds study activation. It also enables faster and more quality trial execution. To speed up study activation and reduce manual work, you can replace manual processes with your own workflows. Monitors will have secure, direct access into your source and regulatory documents. This will eliminate the need to redact or grant EMR access. You can create your own workflows, reports and dashboards to gain greater insight into regulatory processes and start-up timelines.
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LifeSphere eTMF
LifeSphere eTMF provides a single source of truth for your clinical trial. Discover a flexible solution that streamlines the inspection process, ensures compliance and saves time and effort for your organization. LifeSphere eTMF is the first system that supports the TMF reference models. It aligns Clinical documentation, regulations and study protocol in one solution. Create and manage your clinical trial from a single source. Live collaboration and real-time sharing of documents will ensure the quality, timeliness and completeness of your trial master files. TMF inspections can be streamlined quickly and efficiently for any audit. Maintain compliance using embedded workflows and dashboards which allow easy trial reconstruction.
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Datatrial Nucleus
One platform to research, document, and collate your clinical data. The Nucleus platform simplifies research data. One platform to store all your study documentation, clinical data, submission data, and compliant media. Nucleus Documents allows you to manage and control your media and quality documentation. You can easily manage, control, and share company content. Our centralized regulatory document management solution makes it easy to manage and collect electronic trial master files. Nucleus Coding allows you to code dictionary terms against both WHODrug and MedDRA dictionaries. It can be used in our standalone application or integrated into your data capture software.
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RegDocs365
A scalable, real-time, collaborative, out-of-the box solution for CROs, Life Science Consultants and Industry Stakeholders. Built in an Audit Ready Compliant Cloud environment (ARCC). All 21 CFR Part 11 requirements are met. GxP audit ready. Pre-configured Departmental. Communications with internal and external stakeholder. Secure data integration between remote teams. Collaboration in review and approval. Turn access on/off according to need (EX: auditors), reducing audit prep time from days to hours. Preconfigured to eTMF Reference models & EDM. Intelligent content management tools can improve workflows. Improve document management with real-time collaboration, automatic indexing and co-authoring. Pre-configured, validated system that manages documents and data electronically in accordance with eCTD mandates.
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Pricing
Free Trial:
Yes
Integrations
No Integrations at this time
Company Details
Company:
VACAVA
Year Founded:
1996
Headquarters:
United States
Website:
www.vacava.com
Media
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Product Details
Platforms
SaaS
Type of Training
Documentation
Live Online
In Person
Customer Support
Phone Support
Online
VACAVA Regulatory Document Management System Features and Options
Document Management Software
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
Clinical Trial Management Software
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
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