IWRS

ClinicalHawk IWRS is a cloud-based Interactive Web Response System designed to manage clinical trial supply logistics, randomization, and real-time data reporting. It is intended for clinical trial teams running studies of varying scales, from small single-site trials to large multi-center and global studies, and supports both sponsors and site staff with varying levels of technical expertise.

The system addresses core challenges in clinical trial operations including supply chain management, regulatory compliance, and randomization integrity. It integrates with other eClinical tools such as electronic data capture (EDC), electronic Trial Master File (eTMF), clinical trial management systems (CTMS), and document automation platforms to support a unified approach to trial management.

Randomization Capabilities

• Supports multiple randomization methodologies: simple, block, stratified, and adaptive randomization.
• Automates the randomization process to reduce the risk of human error and maintain consistency.
• Allows mid-study adjustments to randomization procedures without disrupting ongoing operations.
• Uses algorithms designed to minimize bias and support the reliability of trial results.
• Supports adaptive randomization based on interim analysis and trial progress.

Inventory and Supply Management

• Provides real-time visibility into inventory, including tracking of shipments, receipt, and usage of supplies.
• Automatically calculates resupply needs based on usage patterns and predefined thresholds to reduce the risk of shortages.
• Offers site-specific inventory management, enabling tracking and management of supplies at the individual site level.
• Includes integrated temperature monitoring for trials involving temperature-sensitive products, tracking storage and transport conditions.
• Advanced analytics and reporting capabilities support proactive identification of potential shortages or overstocking issues.

Compliance and Regulatory Reporting

• Documents all system actions to provide a clear audit trail for regulatory inspections and internal reviews.
• Supports compliance with FDA 21 CFR Part 11, EMA, and ICH GCP guidelines.
• Includes built-in validation checks and secure electronic records to maintain data accuracy and reliability.
• Employs advanced encryption to protect sensitive trial data.

Blinding and Unblinding Management

• Supports various blinding methods to maintain trial integrity.
• Provides secure and controlled unblinding processes when required.

Interface and Customization

• Offers a user-friendly interface designed for users with varying levels of technical expertise.
• Customizable dashboards, reports, and alerts allow users to configure the information they receive and how it is displayed.
• Can be tailored to meet the specific protocols and workflows of individual clinical studies.
• Supports multiple languages, making it suitable for global trials with diverse participant populations.

Support and Training

• Provides comprehensive training programs covering basic operation through advanced features, tailored to team needs.
• Offers onboarding assistance and user training sessions.
• 24/7 technical support is available for issue resolution.

Integration and Deployment

• Cloud-based deployment provides flexibility, scalability, and remote access.
• Integrates with EDC, eTMF, CTMS, and document automation tools within the ClinicalHawk eClinical suite.
• Integration with other systems supports data consistency across trial management functions.

ClinicalHawk IWRS is a cloud-based system developed by ClinicalHawk Systems, operating under N2NAcers. It is positioned for use across the worldwide life sciences industry and can be evaluated through a personalized demo arranged via the ClinicalHawk sales team.