Data literacy is a simple concept. Looking at data related to your area of specialty, you can deduce insights, ask appropriate questions, and make clear data-based decisions. Within the clinical trial ecosphere, each role requires a different degree of skill both vis-à-vis data in general and the trial data specifically.
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The ICH E6 guidelines has set the clinical trial industry standard since it was first published in 1996. As clinical trials and technologies, however, continue to rapidly evolve, there is a need for these guidelines to shift as well. The industry has called for a revision of the ICH E6 (R2) guidelines to spotlight risk-based…
As today’s clinical trials grow increasingly complex, risk-based monitoring has become the watchword of the day. It is integral to any quality management program; it is mandated by regulatory agencies; and, critically, it is a potent tool for forestalling costly failures…
“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.”
Celebrating its 12th successful year, SCOPE Summit 2021 takes place March 2-4, 2021 as a fully virtual event. During these difficult times of a global pandemic, the work this clinical research community does is more important than ever and requires collaboration and innovation. Over the course of three stimulating days of in-depth discussions in 23 different conferences, 5 plenary keynote sessions, the 5th annual Participant Engagement Awards, the new China Clinical Development Partnering event and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial innovation, planning, management and operations.
Our webinars feature thought leaders from CROs, agile biotechs, and large pharmaceutical companies to bring you educational and scientific insights on a variety of subjects. Browse our on demand library for the latest insights.
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. Contract Research Organizations (CROs) and sponsors are juggling increased data volume, increased data variety and the demands of risk-based monitoring, all in service of risk-based quality management (RBQM)…
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…
Our team is geared up and ready to meet you all over the world. We’re excited to connect to learn more about your needs at the following conferences. Contact us to schedule a meeting at any of the conferences below.
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:
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:
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.