EDC

ClinicalHawk EDC is a cloud-based Electronic Data Capture system designed for clinical trial data collection, management, and storage. It is built for clinical trial sponsors, Contract Research Organizations (CROs), academic researchers, and pharmaceutical companies. The system supports all trial phases and post-approval studies, replacing traditional paper-based data collection with digital workflows that include online edit checks, query management, and real-time reporting.

The platform is designed to be accessible to users across technical skill levels, with configurations adaptable to studies ranging from small pilot trials to large multi-site clinical programs. Pricing is customized based on study scale and requirements, and the system is designed for rapid deployment, with setup possible within a few hours.

Data Collection and Management

• Intuitive interface intended to simplify data entry and reduce errors across user types
• Real-time data access via a cloud-based platform, supporting timely decision-making during active trials
• Multi-site data integration and synchronization for studies conducted across multiple locations
• Remote data access from any internet-connected device

Security and Regulatory Compliance

• Compliant with GDPR, HIPAA, and 21 CFR Part 11
• Encryption and secure access controls to protect sensitive clinical data
• Comprehensive audit trails that record all data modifications
• Automated data validation checks to maintain data integrity
• Automated data backups and a disaster recovery plan to minimize downtime and data loss
• Continuous monitoring of regulatory changes with system updates to reflect current standards

Customization and Scalability

• Highly customizable configurations, forms, and workflows to match the specific requirements of individual studies
• Scales to accommodate increasing data volumes and additional users without performance degradation
• Suitable for pharmaceutical trials, academic research, multi-site CRO studies, observational studies, and real-world evidence (RWE) trials

Workflow and Collaboration

• Automated workflows and task assignments to reduce administrative burden on research teams
• Role-based access controls allowing team members to access relevant data while maintaining security
• Integrated collaboration tools to support communication and data sharing among study teams

Support and Training

• Dedicated support team available for technical assistance throughout the study lifecycle
• Training resources including webinars, tutorials, and user guides
• Personalized assistance available from the support team on request

Use Cases

• CROs: Audit trail and data validation features support compliance and data integrity across sponsor collaborations
• Pharmaceutical companies: Real-time data access and security measures support drug development workflows and faster time-to-market
• Academic researchers: Customizable configurations and scalability support management of complex and expanding research projects

ClinicalHawk EDC integrates with other clinical trial management systems to support data flow across platforms. The system also offers integration with related tools including an Electronic Trial Master File (eTMF) and Randomized Trial Supply Management (RTSM) solutions within the ClinicalHawk product suite. Demos and customized pricing quotes are available through the ClinicalHawk sales team.