eTMF

ClinicalHawk eTMF is a cloud-based electronic Trial Master File system designed to manage the documents, tasks, and workflows associated with clinical trials. It is built for clinical trial sponsors, Contract Research Organizations (CROs), academic researchers, and pharmaceutical companies. The system is hosted on a secure Oracle database and accessible from any internet-connected device, including laptops, mobile phones, and tablets.

The platform supports regulatory compliance through automated workflows, document version control, audit trails, and secure storage. It adheres to industry standards including GDPR and HIPAA, and is designed to keep organizations audit-ready throughout the trial lifecycle.

Key Features

• Cloud-based accessibility: Users can access the system from any location and any device, supporting geographically dispersed teams.
• Quick study setup: New studies can be configured within a few hours, reducing delays at the start of a trial.
• Custom report building: Users can generate tailored reports for compliance purposes or bespoke data analysis, supporting decision-making throughout the trial.
• Automated workflows and intelligent document categorization: Documents are automatically filed and made easily retrievable, reducing manual administrative work and the risk of misplaced files.
• Document version control and audit trails: Supports regulatory compliance and audit readiness.
• Real-time document sharing and editing: Enables collaboration across teams working in different locations.
• Scalability: The system can accommodate single studies or multiple complex trials without performance degradation.
• Device-agnostic design: Consistent user experience across laptops, mobile phones, and tablets.

Security and Compliance

• Built on an Oracle database with data encryption and regular security audits.
• Cloud infrastructure provides high availability and disaster recovery capabilities.
• Compliant with GDPR and HIPAA requirements.
• Audit trail functionality supports regulatory inspection readiness and reduces the risk of regulatory penalties.

Integration and Interoperability

• Integrates with other clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Designed to reduce data silos by enabling information flow between connected systems.

Support and Ongoing Development

• Personalized support is available for system setup, troubleshooting, and general queries.
• The system is updated regularly with new features and enhancements based on user feedback and industry trends.
• Pricing is provided on a tailored basis; prospective users are directed to contact the sales team for a quote.

ClinicalHawk eTMF is a cloud-hosted solution requiring no on-premises infrastructure. It is offered by ClinicalHawk Systems, which also provides Electronic Data Capture (EDC) and Randomized Trial Supply Management (RTSM) tools as part of its clinical software portfolio.