Fortress Medical Systems

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Healthcare & Pharmaceuticals | Pharmacy Management Software

https://www.fortressmedical.com/ 9522389010
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Product Overview

Fortress Medical Systems

Clindex Clinical Trial Software

A Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS) and Electronic Data Capture System (EDC) all in one powerful, integrated solution.

Fortress Medical Systems was founded in 1997 with the launch of Clindex [part of EvidentIQ Group since 2021], the first integrated clinical trial software system designed specifically for medical device trials. Over the years, Clindex has been used to support not only medical device studies, but also pharmaceutical, diagnostic and combination product studies. By working closely with our customers, we have expanded the functionality of Clindex so it is one of the most flexible and comprehensive systems on the market today. Our client base spans the world. As a testament to the scalability of Clindex, our clients range from Fortune 500 corporations to small, start-up companies and include many contract Clinical Research Organizations (CROs) as well.

Clindex has been used in hundreds of studies, a large majority of which were to support marketing applications to the FDA. Clindex EDC has been deployed worldwide with investigational sites spanning the globe. The FDA has audited studies conducted with Clindex and to our knowledge no finding or deficiency has ever been attributed to Clindex.

Just as our software and client base have expanded over the years, so has our service offering. We offer services including implementation and configuration, database development, CTMS configuration and full Application Service Provider (ASP) services as a SaaS (Software as a Service) model.

Our clients range from small start-up companies to Fortune 500 corporations. The US Centers for Disease Control and Prevention and many contract Clinical Research Organizations (CROs) use CLINDEX for their studies.

Specifications

Clinical Trial Management System

As a comprehensive clinical trial management system, Clindex drives efficiencies and results across the entire clinical trial process, from site selection through study close-out.

CTMS software features include IRB/EC, regulatory, and protocol tracking; visit scheduling and compliance; enrollment tracking; product management; comprehensive e-monitoring; site payments; document management system; plus the ability to add features unique to your needs.

Unlike some Clinical Trial Management Systems that are created by connecting existing CTMS and EDC systems, Clindex is a single system, offering you all the functionality you need in a single eClinical solution.

Clinical Data Management System

Clinical Data Management

A full-featured clinical data management system, Clindex offers a wide breadth of functionalities to ensure data quality and keep you informed, such as streamlined data entry; powerful reporting; automatic email alerts, notifications and reports; simple to complex validations; closed-loop query management; tabular data browser; built-in data loader; data exporting; and much more.

Secure. Clindex offers a comprehensive set of security features to ensure your data is safe and secure. With strong password controls, role-based security to individualize access and double audit trails, Clindex meets regulatory and industry standards including 21 CFR Part11.

Flexible. Clindex is extremely configurable to meet your unique trial needs – in design, data capture technology and deployment.

Scalable. As a testament to the scalability of Clindex, the system has been used for everything from large, complex pivotal trials to small feasibility studies. Our clients range from the small startup to Fortune 500 medical companies. Not only does it meet your needs now, but Clindex will continue to meet your needs as your organization grows.

Electronic Data Capture Software

Intuitive EDC – You need compliant and timely data. Your sites want a system that is easy to use and intuitive. Clindex Electronic Data Capture software delivers with a simplified dashboard, superior navigation tools, immediate data quality feedback, workflow assistance, document sharing capability, reports, and more! Flexible and user friendly.

Streamline data management and site communications – Clindex Electronic Data Capture software enables you to provide your study sites the ability to enter and manage their own CRFs, run reports and exchange study documents; when, where and how you want. Improve efficiencies and data quality. Reduce data processing and study administration time, and for your clinical staff, maintain process and data integrity and simultaneously create efficiencies for your site users. By using state of the art technology, there is no need for your sites to install or worry about having the right version of the clinical software.

Optimized data collection – With Clindex, you are able to conduct your study as EDC, paper-based or a hybrid of methodologies. You don’t have to be locked into one data collection method or have your data collection method lock you out of sites – you can choose the best methodology for each site, right down to the eCRF page, all within one unified solution. Clindex, the visionary clinical software, has been offering hybrid capability since 2003.

Reduce data closure time – Give study sites access to their data and enable them to manage data quality, to conduct real-time data queries, and to track upcoming due dates. And you control which site users can access, sign and modify eCRFs based on Clindex’s role-based security.