Modern clinical trials generate reams of data from multiple sources, creating enormous information management challenges for sponsors. Today, the growing popularity of decentralized clinical trials (DCTs) only exacerbates the problem. It is not enough to cobble together multiple management systems; these new approaches to trials require new clinical trial management systems (CTMS). A modern CTMS must organize and centralize issue management thereby simplifying trial oversight and increasing sponsor efficiency. This “unified approach” is at the core of the Remarque Systems platform.
Launched in 2015, Remarque seamlessly centralizes data from multiple technologies and processes. Remarque combines the initial start-up process, the investigative database, the contact management system, the communication log, action items, protocols and protocol deviation tracking, and risk management, bolstering both accessibility and efficiency. Remarque then monitors every aspect of the data to quickly identify the root cause of problems. In addition, Remarque studies and stores downstream analysis and key data in the electronic Trial Master File (eTMF) instead of in written reports; significantly, sponsors can access reports in real-time, share them among teams, and search them.
Through this approach, risk management becomes easier. This single platform enables sponsors to monitor onsite data, track project management, and review project milestones and documents—all in real time. The result: Remarque Systems accelerates process optimization, increases visibility, enhances communications, and improves the quality of clinical data management, operations, and functions.
“Biotech and specialty pharma companies have been hamstrung in the past by poorly integrated systems that lead to a lack of consistency. Our goal is to fix that. Our vision statement outlines our approach of a unified CTMS platform for managing both the clinical trial itself and the data it produces,” said Joseph Goodgame, President of Remarque Systems.
Two emerging issues. One singular solution.
Looking ahead, Remarque has anticipated two emerging areas that are not currently addressed by traditional CTMS: an increased emphasis on risk monitoring, and the growing prevalence of DCTs. Remarque Systems solves for both.
Most CTMS systems have discovered how to capture a risk log, but they haven’t truly integrated it into their processes; they have simply bolted on a capture mechanism. Rather than approaching risk management from the risk standpoint, Remarque’s unified approach addresses it from the issue-management standpoint. With all issue-management centralized on the platform, all groups are tracking and managing issues in the same place, using the same data inputs. Further, the Remarque Systems platform integrates all the data and other information throughout a trial, then seamlessly applies built-in analytics, triggers, and alerts for a proactive and completely unified approach.
These same features effectively support DCT data management, too. Because Remarque’s integrated platform seamlessly imports data from all the disparate technologies used in a DCT, it helps close the gap between data collection and data review. Once the data are consolidated, Remarque’s advanced data visualization capabilities allow teams to identify trends and outliers, helping mitigate and manage any risks.
Evolving technology for an evolving industry
Lack of centralized issue-management is a serious concern for many sponsors. To effectively address this concern, a CTMS should not simply offer a way to monitor onsite visit reports and track project management, enrollment, milestones, and document completion; it should help holistically manage a trial.
The only way to get a truly complete picture of a trial is to centralize issue management across every type of monitoring—as the Remarque System does. This scrutiny illuminates frequent sources of problems, such as poor handovers from one group to another. Moreover, leveraging the ability to analyze data from a site report visit or patient record in real time uncovers issues in real time—whether from general data surveillance, onsite concerns, or via monitoring of a pre-identified safety risk. In short, by managing for issues, sponsors can also manage for risk.
Remarque also helps groups keep processes flowing. For instance, once certain study start-up tasks are complete, a trigger alerts the monitor to schedule the initiation visit. This type of automation can be employed throughout the trial, eliminating communication gaps and bottlenecks that can arise from manual processes.
Remarque has also revolutionized site visit report reviews. As other parts of the clinical trial process have modernized, little has changed with the review process. Typically, data review involves manually creating and filling out templates using word processing, followed by a monotonous and time-consuming round robin of document sharing, emails, and phone calls. Most technology vendors have simply replicated this existing document process rather than focus on developing a new way. Remarque has taken a different approach.
By thinking of a site visit report as a collection of questions, answers and datapoints rather than as a set of documents, Remarque has drastically changed the speed and focus of reviews. A configuration-driven series of components includes Questions, Answers, and Notes; the system automatically links items like protocol deviations and action items. Reviewers can focus on the content rather than the template. Quick on-screen indicators show where review is required and the level of completion; direct links to review notes and responses make the process more efficient, more accurate, and more intuitive, reducing the need for training.
With this system, site visit reports are completed much more quickly—indeed, clinical leads report that they are as much as 80% faster. Moreover, by breaking down the document into the underlying components and data, sponsors can quickly analyze trends and patterns, finding site-level issues that were impossible to identify quantitively in the old documents.
Of course, the clinical trial industry does not stand still, and neither does Remarque. As customers’ challenges change, the company continually iterates and expands its offerings, working closely with sponsors to help drive over-arching process improvement and productivity.
The unified approach of a modern CTMS
Remarque Systems has evolved from a unified risk management platform to a unified clinical trial management platform. That evolution will continue as the industry adopts more diverse trial approaches, especially decentralized trials. Remarque’s expertise, knowledge, and passion will continue to reduce manual documentation, drive productivity, and minimize risk in clinical trials.
Headquartered in Raleigh, North Carolina, Remarque Systems is a SaaS application-based company that provides a platform to unify and manage clinical data systems. It analyzes data from various sources and locations in real time and offers transparency and monitoring of data, risk management, and centralized issue management.