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The Remarque Systems platform is one single integrated solution that connects clinical trial data by centralizing all data sources without the complexity of using multiple separate components. Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time.

Key highlights of our platform are:

• Holistic risk management
• Data analytics including AI and machine learning

No. EDC systems are one of the methods that data is collected on a clinical trial. The Remarque systems platform is designed to manage a clinical trial no matter how the data is collected (EDC, EMR, eSource, Device, Labs, Safety Systems etc.)

The Remarque Systems platform is more than just a CTMS. While a traditional CTMS is only designed to manage onsite monitoring, the current environment requires a system to support the three different types of monitoring (Onsite, Remote and Centralized).

The Remarque Systems platform allows you to replace your CTMS and meet regulatory needs on other types of monitoring.

The Remarque Systems platform is designed to be a comprehensive toolset for managing a clinical study.

The platform supports the following functions:

• Machine learning
• Template library
• Data ingest
• Data analytics
• Workflows
• Alerts
• Action items

• Ecosystem compatibility with existing systems & processes
• RBM audit trail
• System configurability vs customizations
• Customer experience & development teams
• Operational & analytical platform in one system
• Continuous improvement and expansion of platform

Yes. With our platform, you can receive benefit from our knowledge gained in specific therapeutic areas. The Remarque Systems platform has proven itself across multiple therapeutic areas.

In general it takes four-to-six weeks to get a study up and running. Much of this time is dependent on the length of time the customer requires for their own UAT activities. If system templates are being applied to create new studies over time, the length of time to launch a study can significantly decrease.

The platform was designed to be self-service but we provide multiple tiers of support to our client base. Normally we provide support to our clients for the first study and then afterwards train the customer on all of the self-service aspects.

You are able to pick and choose the modules you want. Our platform is designed to easily fit into your existing ecosystem.

Yes, the ability for the platform to support multiple players in managing a clinical trial is essential. It is common that data management is provided by a team or company other than Risk management or Medical monitoring etc.

We work with all companies in the Pharmaceutical, Biotech, Device, CRO and ARO.

Yes, CROs have unique challenges not experienced by sponsors in that they must frequently manage to different standards driven by their customers. We have ensured the design of the Remarque Systems platform to fully support that.

As a true SAAS platform, access is via the web over secure https connectivity.

System access is controlled by the client. Access is granted directly in the platform and supports both local accounts and fully federated solutions with SSO.

There is no limit to number of users. Additionally, costs are not driven by users.

Yes, our platform is validated.

As a multi-tennant SAAS platform, security is of paramount concern. We leverage all available security methods with our hosting provider and regularly test the application for security vulnerabilities.

Yes.

Yes, we have been audited multiple times by our clients.

A client service representative is assigned to each study and will support and help organizations configure the system to meet their needs. In addition, we have a helpdesk support team who can deal with technical issues or product questions.

Training is offered in a variety of different ways, including training manuals, help text within the application, and e-learning modules, and remote or live training classes.

We have conducted studies globally.

Please feel free to Request a demo, call us at (919) 261-5830 or email us at info@RemarqueSystems.com.