Study Tool

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.

Key Features and Capabilities of Study Tool

1. Create Unique Observations and Hassle-Free Data Management

Designing a case report form (CRF) that accurately captures patient data is a crucial step in any research study. Our QuantiNova Study Tool (STANOVA®) makes it easy to create customized CRFs that meet your specific research needs. With dynamically available input fields, you can:

  • 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

Regulatory compliance is a top priority in biomedical research. That's why our QuantiNova data analysis tool(STANOVA®) is hosted on a secure STPI (Software Technology Parks of India) server, ensuring that your study data analysis meets the stringent requirements of 21 CFR Part 11. This means you can trust that our tool:

  • 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

Our team of experts is dedicated to helping you design custom CRFs and study templates that meet your unique research needs. We'll work closely with you to:

  • 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

Maintaining a comprehensive audit trail is crucial for ensuring transparency, accountability, and compliance with regulatory guidelines. Our Quantinova Study Tool (STANOVA®) provides a strong audit trail and version control system, giving you complete visibility into all study-related activities.

  • 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

Monitoring study progress in real time is critical for identifying potential issues and discrepancies. By accessing real-time data monitoring, our tool helps you stay on top of study progress and ensure data quality. Our Quantinova Study Tool provides:

  • 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

Compliance with regulatory requirements is critical in clinical research. By providing a compliant platform for research, our study tool helps you streamline your workflow and focus on your research goals. Our Quantinova Study Tool (STANOVA®) is designed to support compliance with:

  • 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.