News & Views

1 min read

Data Literacy: The Foundation for Modern Trial Execution

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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1 min read

Clinical Trial Evolution: The Drive to Update ICH E6

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

1 min read

How to Manage Machine Learning Algorithms in Clinical Trials

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…

Exhibition & Speaking Events

Scope-Virtual-Event
02 Mar

SCOPE Virtual Event

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.

Webinars

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.

webinar
DATE: 16th March 2020

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. 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)…

Webinar-1
DATE & TIME: 4th August 2020 - 14:00HRS

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…

Networking Events

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.

OCT Europe

DATE: TBC

OCT West Coast

DATE: 24th-25th February

SCOPE

DATE: 2nd-4th March

ACRP

DATE: 14th-17th May

DIA Annual

DATE: 27th June-1st July

PCMG

DATE: 14th-17th September

OCT Southern California

DATE: 29th-30th September

SCOPE Europe

DATE: 5th-6th October

OCT New England

DATE: 9th-10th November

FAQs

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
  • Workflows
  • Alerts
  • 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?

Yes.

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.