Efficient Data Management & Collaboration for Clinical Research
Quantinova Study Tool (STANOVA®) aims to improve the efficiency, quality, and reliability of research data in clinical trials, ultimately contributing to better healthcare outcomes and advancements in scientific knowledge.
But that’s not all. STANOVA® also allows you to manage user roles, giving you complete control over who can access and edit your study data. Assign different levels of access to team members, collaborators, or external partners, and rest assured that your data is secure and protected.
1. Create Unique Observations and Hassle-Free Data Management
- Easily add or remove fields as needed
- Configure fields to capture specific data types (e.g., dates, numbers, text)
- Create conditional logic to ensure data consistency and accuracy
- Design a user-friendly interface that reduces errors and increases data analysis quality.
2. Compliant with 21 CFR Part 11
- Meets the highest standards for data security and integrity
- Provides a tamper-evident audit trail for all data changes
- Supports electronic signatures and authentication
- Is regularly updated to ensure ongoing compliance with regulatory guidelines
3. Expert CRF Designing and Study Template Designing
- Understand your study protocols and data collection requirements
- Design intuitive and user-friendly CRFs that capture the right data
- Develop comprehensive study templates that ensure consistency and accuracy
- Provide training and support to ensure a smooth implementation process
4. Audit Trail and Version Control
- Detailed logs of all data changes, updates, and modifications made to your study data.
- Assign unique user IDs and passwords
- Define role-based access controls
- Track user activity, and set up alerts for suspicious activity to ensure secure and controlled access to the system.
5. Real-Time Data Monitoring
- Real-time data tracking and visualization.
- Customizable dashboards and reports
- Alerts and notifications for potential issues
- Tools for data cleaning and validation
6. Compliance and Regulatory Support
- Good Clinical Practice (GCP) guidelines
- International Council for Harmonisation (ICH) guidelines
- 21 CFR Part 11 and other regulatory requirements
Target Audience
Researchers and Investigators
The Quantinova data observability tool is designed for researchers and investigators conducting clinical trials in medicine, and healthcare.
Clinical Research Organizations (CROs)
CROs can utilize the platform to manage multiple studies, streamline data collection, and ensure compliance with regulatory requirements.
Academic Institutions
Academic institutions can leverage the platform to support research initiatives, promote collaboration, and ensure data quality and security.