Engility Platform

The Engility® Platform by PHARMASEAL is a modern, cloud-based clinical trial management system (CTMS) and electronic trial master file (eTMF) solution designed for life sciences organisations navigating increasingly complex and costly clinical development programmes. Built to support hyper-collaboration, integrated supply chains, agile processes, and management oversight, Engility® addresses the growing demand for flexible operating models that improve productivity across clinical trial operations.

Engility® delivers a unified, integrated suite that increases collaboration and oversight, reduces technology costs, and is engineered on a scalable cloud architecture built to support the trials of the future. The platform is designed for sponsors, CROs, and site teams seeking a single, cohesive environment to manage all aspects of clinical trial operations with rapid implementation — up to three to four times faster than competing platforms — and a superior total cost of ownership.

Key Platform Benefits

• Collaboration & Oversight: A flexible security model encourages shared use, fostering supplier collaboration and increasing trial oversight across all stakeholders.
• Usability: An intuitive and interactive interface provides a seamless, efficient user experience designed to delight end-users and drive system adoption.
• Integrated Suite: Removes administrative overhead and increases process efficiencies across clinical trial operations by consolidating capabilities into a single platform.
• Cloud Technology: Modern cloud architecture provides business continuity and collaboration efficiencies, supporting multiple operating models and reducing total cost of ownership.
• Quality & Compliance: Automation generates software validation required for regulatory compliance, supporting faster release cycles and ongoing innovation.
• Rapid Implementation: Industry-standard reference data and configuration accelerates implementation speed by up to three to four times compared to competing platforms.

Trial Management Capabilities (CTMS)

• Study Management: Track and manage all aspects of studies, including milestones, enrolment, team management, payments, and issue management at the study, country, and site levels.
• Site Monitoring: Flexible site monitoring capability supporting both traditional and risk-based monitoring approaches, with a focus on increased structured data capture and reduced manual data entry.
• Site Payments: Manage site contract term negotiation and benefit from automated payment calculation, minimising manual payment tracking for site payments.
• Issue Management: A centralised, collaborative issue management and protocol deviation tracking capability operating at study, country, site, and subject levels.

Electronic Trial Master File (eTMF) Capabilities

• Regulatory Document Tracking: Track document metadata and store direct links for documents being captured outside of the Engility® platform.
• eTMF Document Management: Store documents directly within Engility® for a fully integrated eTMF storage capability.
• Metadata & Content Searching: Full metadata and content searching provides an intuitive way to locate documents and take immediate action.

Engility Platform Services

• Administration: Flexible administration allows company standards to be configured across all trials, while permitting study, country, and site-specific modifications to be tailored as needed.
• Contact Management: A single contact management database is maintained and utilised across all Engility domains, ensuring a single source of truth and eliminating the need to rekey contact data in multiple places.
• Reference Data: Industry and company-wide data can be utilised across the portfolio to accelerate set-up, reduce data duplication, and improve information consistency.
• Security: A flexible security model supports varying levels of access control at customer, study, country, and site levels, with complete configurability of platform functionality for any given role.
• Business Intelligence: Powerful business intelligence is delivered through embedded dashboards and system reports across all aspects of the platform, with the ability to select and filter reports across studies, countries, and sites.
• Integration: Designed to seamlessly integrate into a clinical software ecosystem, Engility® supports direct API connections or integration services to connect with other software used within an organisation.

Engility® is delivered as a cloud-based platform with a scalable architecture suited to organisations of varying sizes and operating models. Its integration capabilities, regulatory compliance automation, and unified data model make it a comprehensive solution for life sciences companies seeking to modernise and streamline their clinical trial management operations.