Regulatory Document Management System

VACAVA's Regulatory Document Management System is a cloud-based solution designed for CROs, SMOs, sponsors, and clinical trial sites that need to manage regulatory documents and electronic signatures online. The system was developed in collaboration with a major clinical trial research base and is intended to reduce the complexity and cost of managing regulatory documents throughout the clinical trial lifecycle.

The platform stores profiles, forms, and documents in a single online location, allowing documents to move through approval workflows electronically. It is 21 CFR Part 11 compliant for electronic signature capture and is delivered via the cloud, removing the need for users to manage servers, security, or backups. The system is described as customizable and scalable to meet varying organizational needs.

Key Benefits

• Simplified trial and document management: Reduces manual workflow steps that can introduce delays and lost information.
• Document access anywhere, anytime: Online storage allows remote access to regulatory documents.
• Secure document sharing: Documents can be shared securely across stakeholders.
• Dynamic data updates: Supports real-time updates to document data.
• Managed compliance: Supports regulatory compliance requirements including 21 CFR Part 11.
• Customizable: The system can be adapted to meet the specific needs of different organizations.

Features

• Trial and document management dashboards: Easy-to-read dashboards support efficient oversight of trials and documents.
• Electronic signature capture: Approvals and signatures are captured electronically in compliance with 21 CFR Part 11.
• Automatic form population: Forms can be populated automatically to reduce manual data entry.
• Deadline triggers: Automated triggers help track and manage document deadlines.
• Change history: The system maintains a record of document changes over time.
• Scalable architecture: The platform can scale to accommodate growing organizational needs.

Case Study Highlights

• A leading cancer center used VACAVA's system to reduce the complexity and cost of clinical trial regulatory document management.
• A case study published by the Association of Clinical Research Professionals (ACRP) in Clinical Researcher documented quantifiable benefits from implementing VACAVA's paperless regulatory document management solution, with reported improvements in productivity, study start-up speed, and inspection readiness.

VACAVA's Regulatory Document Management System is delivered as a cloud-hosted service, with VACAVA managing server infrastructure, security, and backups on behalf of users. The system is positioned as an affordable option relative to the operational savings it provides. Prospective users can contact VACAVA directly for live demonstrations or further information.