MORRISVILLE, N.C., September 22, 2021 — Remarque Systems and Oracle Health Sciences have announced a collaboration to help customers manage clinical trial risk in real-time as part of the latest expansion of the Oracle Clinical One platform. Remarque Systems is a member of Oracle PartnerNetwork (OPN). Now customers can use a single unified platform that…
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The International Council for Harmonisation (ICH) establishes industry-wide standards for clinical trials – and those standards are undergoing a complete rewrite, affecting the ways trial data is monitored, analyzed, and de-risked. These changes are being developed both at the behest of and with extensive input from a wide range of industry insiders; and they are…
An industry-wide drive to speed study start-up Life science industry reports indicate that the early stages of study start-up take twice as long today as they did five years ago. The primary reason may be that, as trials have grown in complexity, so too have data collection activities related to site identification, feasibility ranking, and…
“A nimble company with a focus on customer service, Remarque spent the time to brainstorm various configurations to find the optimal solution for their client, then was able to offer end-to-end deployment that noticeably abbreviated the implementation timeline. In short: They were able to launch the study in record time, while maintaining the safety of the trial team.”
“We knew that implementing Remarque technology would improve our efficiency, but it was impossible to understand how dramatically our efficiency would increase until we actually implemented the technology and experienced the difference. We now do in 30 minutes what used to take a full 8-hour day.”
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Modernizing Your RBQM Program with Automation and Integration
A well-functioning risk-based quality monitoring (RBQM) program is a must-have for today’s clinical organizations. Historically, some RBQM systems have been mired by challenges. The core cause is the difficulty in which data can be extracted from many data collection systems. As a result, some RBQM systems limp along without a complete set of data.
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Unprecedented Data-Monitoring Backlogs & How To Deal With It
Kristin Mauri & Rhonda Roberts
Recently, industry publications have filled with COVID-19-related clinical trial stories. As biotech and pharma companies the world over the race for a vaccine or a cure, there is another pandemic tale that is going unheralded: the virtual halt to real progress on clinical trials for anything except COVID-19. Though most fully halted trials were just…
Sharp Thinking: A New Angle on Clinical Trial Management Systems
New technologies are inevitably heralded as making life simpler: streamlining tasks, eliminating steps, managing things so you don’t have to manage them. Yet the practical application of a new technology often seems to make things more complex.
Clinical trial management is a case in point.
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What is the Remarque Systems platform?
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
Is the Remarque Systems platform an Electronic Data Collection (EDC) system?
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.)
Is the Remarque Systems platform a Clinical Trial Management System (CTMS)?
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.
What additional functionality does Remarque Systems platform have?
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
- Action items
How is Remarque Systems different from other systems?
- 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
Can the Remarque Systems platform be used in all therapeutic areas?
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.
How long does it take to launch a Study?
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.
Can we manage the system ourselves?
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.
Do I have to buy the entire platform, or can I pick and choose the modules I want?
You are able to pick and choose the modules you want. Our platform is designed to easily fit into your existing ecosystem.
Can the Sponsor/CRO provide Data Management?
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.
What type of clients do you have?
We work with all companies in the Pharmaceutical, Biotech, Device, CRO and ARO.
Do you work with CROs?
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.
How can you access the system?
As a true SAAS platform, access is via the web over secure https connectivity.
Who gets access the system?
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.
Is there any limit to the number of users of any kind?
There is no limit to number of users. Additionally, costs are not driven by users.
Is your platform validated?
Yes, our platform is validated.
How secure is the system?
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.
Do you have Business Continuity and Disaster Recovery Plan?
Have you been audited?
Yes, we have been audited multiple times by our clients.
How do you support your studies?
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.
How do you perform the training?
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.
Do you operate internationally? Where have you conducted studies?
We have conducted studies globally.
How do I start?
Please feel free to Request a demo, call us at (919) 261-5830 or email us at info@RemarqueSystems.com.