Fortress Medical Systems

Fortress Medical Systems, operating under the brand Clindex and now part of EvidentIQ, LLC, develops integrated eClinical software for managing clinical trials. Founded in 1997, the company launched Clindex as the first integrated clinical trial software system designed specifically for medical device trials. Over time, the platform has expanded to support pharmaceutical, diagnostic, and combination product studies. Clindex serves a broad client base ranging from Fortune 500 corporations to small start-up companies and contract Clinical Research Organizations (CROs) worldwide.

Clindex is positioned as an all-in-one eClinical solution covering the full clinical trial lifecycle, from site selection through to study close-out. By consolidating multiple functional modules into a single platform with one login and one database, Clindex aims to eliminate the need for costly integrations between separate systems, reducing both time and potential points of failure.

Core Platform Modules

• EDC (Electronic Data Capture): Supports electronic collection of clinical trial data across investigational sites worldwide.
• CTMS (Clinical Trial Management System): Provides tools for managing trial operations, progress tracking, and administrative workflows.
• CDMS (Clinical Data Management System): Centralises data management within the same unified environment.
• eTMF (Electronic Trial Master File): Manages trial documentation within the same single platform.
• eCOA (Electronic Clinical Outcome Assessment): Included as part of the unified platform offering.

Key Capabilities

• Integrated single database: All EDC, CTMS, CDMS, and eTMF data is stored in one repository with no complicated interfaces or lag time between modules.
• On-demand sponsor access: Study sponsors have full, on-demand access to all data and can generate descriptive statistics with minimal effort.
• Custom form and workflow building: Users can build custom forms, modules, navigation structures, and workflows to meet specific study and project team requirements, replacing uncontrolled spreadsheets with structured administrative forms.
• Advanced reporting tools: Built-in reporting functionality supports ad hoc queries and custom reports accessible by study teams and sites. Drill-down technology allows users to open eCRFs directly from report output.
• Expandability: The platform supports building additional tools and modules, as well as integration with external systems.

Deployment and Services

• Clindex is available as a SaaS (Software as a Service) model through a full Application Service Provider (ASP) offering.
• Services include implementation and configuration, database development, and CTMS configuration.
• The platform has been deployed globally, with investigational sites spanning multiple countries.

Compliance and Track Record

• Clindex has been used in hundreds of studies, a large majority of which supported marketing applications to the FDA.
• The FDA has audited studies conducted using Clindex, and according to the company, no finding or deficiency has ever been attributed to the platform.

Clindex is designed to scale across organisation sizes and study types, and the company continues to develop its functionality in close collaboration with its customer base.