Engility CTMS

Engility® Trial Management, developed by PHARMASEAL, is an integrated cloud-based Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) platform designed for life sciences organisations seeking to consolidate and modernise their clinical trial operations. It is ideally suited for businesses currently relying on disparate or legacy methods to manage trials, offering a unified solution that eliminates the need to invest in and integrate multiple separate systems. By combining CTMS as the operational "brain" and eTMF as the "memory," Engility® ensures users maintain complete visibility and control throughout the entire clinical trial lifecycle.

Engility® Trial Management is built to reduce information fragmentation, lower total cost of ownership, and deliver rapid implementation. Its interoperable architecture connects with other eClinical applications to optimise trial governance and oversight, while its intuitive user interface is designed to drive end-user engagement and productivity across global teams.

Key Benefits of Unified Trial Management

• Unified platform: Eliminates the cost and complexity of integrating disparate CTMS and eTMF systems by delivering both capabilities within a single, cohesive solution.
• Global collaboration: Engineered for worldwide access with multi-language support and a flexible security model that can be adapted to the needs of each organisation, facilitating collaboration with partners across regions.
• Usability: An intuitive, interactive, and engaging user interface provides a seamless and efficient experience that promotes user adoption and engagement.
• Interoperability: Connects with other eClinical applications to increase the visibility and transparency of clinical trial information across the organisation.
• Full data lifecycle: All data is captured within the system without reliance on third-party tools, ensuring a complete audit history, full data accessibility, and elimination of reconciliation burdens.

Trial Management Capabilities

• Admin and configuration: Leverage company-wide templates and configuration settings, with the ability to make study-specific modifications covering everything from dropdown values to complex workflows and access controls.
• Study and contact management: Utilise a global contact management capability to track and manage study and site team members, labs, IRBs/IECs, committees, and regulatory authorities for each trial, reducing data entry errors and reconciliation needs.
• Monitoring: Enable effective site oversight with configurable and collaborative monitoring capabilities supporting both traditional and risk-based approaches, including visit forecasting, monitoring plan templates, and structured data capture and reporting of all monitoring activities.
• Site contracts and payments: Plan, track, and manage global site and investigator payments including multiple payees. Manage multiple versions of site contract terms including fees and holdbacks, and schedule and trigger payment requests trackable at both site and study levels.
• Issue management: Maintain centralised oversight of issues and protocol deviations across the full clinical trial lifecycle at study, country, site, and subject levels, with transparent visibility of issues identified and actions taken to resolve them.
• Business intelligence: Access powerful business intelligence through embedded dashboards and system reports spanning study management, payments, issue management, TMF, and administration. Reports can be filtered across study, country, and site, and a searchable audit trail supports regulatory compliance.
• Regulatory document tracking: Leverage the DIA TMF Reference Model to track document metadata and store hyperlinks to documents held in external repositories.
• eTMF document management: Extend regulatory document tracking by storing documents directly alongside tracking data within a single integrated system. Features include document expiration tracking, placeholders for expected documents, and full metadata and document content searching.

Engility® Trial Management is delivered as a cloud-based solution with rapid implementation and a superior total cost of ownership. Its interoperability with other eClinical applications, combined with its flexible security model and global language support, makes it a comprehensive platform for organisations seeking to streamline and modernise their clinical trial management processes.