Clinical trials today are more complicated than ever given the massive amount of data each trial generates. The classic 100% source data verification clinical trial monitoring method requires checking all data in patients in a manual check. Despite the high precision of the process, it is highly expensive and time-intensive.
Here is where Risk-Based Monitoring steps in, which simply shifts more intense monitoring efforts to those places where it is needed most with analytics and data-driven identification of risks. With RBM, one gets a guarantee of participant safety, data quality, and integrity.
The Octalsoft eClinical suite stands out as the most comprehensive among the many options offered through different channels. In this blog, we are going to talk about the core features that an RBM platform should have, and how Octalsoft's eClinical suite brings to the table the most robust, efficient, and user-friendly capabilities in the market of Risk-Based Monitoring solutions.
What is Risk-Based Monitoring?
A risk-based monitoring strategy is a clinical trial strategy, in which resources and attention are allocated to monitoring based on the risks to the trial. Unlike the traditional monitoring approaches, RBM does not focus on verifying all data points but rather will depend on advanced analytics of data to recognize trends and anomalies that may constitute a potential problem.
The FDA and European Medicines Agency have accepted RBM as a best practice for clinical trial monitoring. They recognize that as the quality of clinical trial data monitoring increases, patient safety is provided with better protection, and less money is spent. Since RBM focuses on key data points and high-risk activities, it will ensure clinical trial teams address the most urgent issues promptly and effectively.
Key Features of Top RBM Platforms
There are a good number of differentiating features that make the best RBM platforms stand out from the rest. Not only do these platforms integrate well with pre-defined workflows, but they also deliver very powerful analytics, customizable risk assessment tools, and real-time data insights. Let's take a closer look at some details:
1. Data Integration and Centralization
An RBM platform also has to gather data from multiple origins like clinical trial management systems, electronic data capture, and other digital platforms. This centralized and aligned data can be viewed in real-time by clinical trial teams to understand the overall state of the trial.
2. Real-Time Monitoring and Analytics
Advanced analytics capabilities on RBM platforms using real-time data for the identification of trends, anomalies, or deviations that may signify risks are highly valued. Predictive analytics and machine learning algorithms are used to forecast issues ahead of time before it gets out of hand.
3. Customizable Risk Assessment Tools
Customized tools will be important elements in the creation of risk indicators and thresholds for RBM platforms. Each trial has its particular profile of risk, so the platform needs to provide the user with a setup to tailor his own framework of monitoring his study needs.
4. Automated Alerts and Escalation Workflows
RBM modules should be automated for automatic alerts and notification messages that are automatically sent to users, with caution about potential risk or deviation. What is more, these platforms must have escalation workflows that support actual critical issues to be addressed and treated before too much time is consumed.
5. Compliance and Audit Trail
Any RBM solution should comply with the international standards in regulation, whether FDA, EMA, or ICH GCP compliance. There should be an audit trail so that all changes and activities done inside the system should be traced out very lucidly as the system gives a history of all activities done by the software for the regulatory inspection.
Why Octalsoft’s eClinical Suite is the Best RBM Solution
Octalsoft's eClinical suite is an integrated platform that encompasses clinical trial management tools from EDC to CTMS, to RTSM, and to RBM. The differentiating feature of this suite, among others, lies in its RBM capabilities in the following areas:
1. Smooth Integration with eClinical Tools
Octalsoft eClinical suite mainly stands to be helpful because of the ease with which the different tools meant for trial management can easily be integrated into a single suite. Using this platform integrates easy imports of data from multiple sources. Examples include electronic patient records and medical devices integrated with the EDC system. Such integration results in giving users one source of truth and putting every feed of data in real-time.
Especially in the case of RBM, such centralization and harmonization are especially helpful because their clinical trial teams obtain insights into both patterns and outliers. Octalsoft's eClinical suite enables very much deeper analyses of near-real-time data which in its turn increases users' accuracy of risk assessments.
2. Advanced Analytics and Machine Learning Algorithms
Octalsoft’s eClinical suite predicts and potentially prevents risks before they become critical by using the latest analytics and machine learning algorithms. With its capabilities, the platform uses historical and real-time data to predict possible patient non-compliance, anomalies in data, or protocol deviation; hence, clinical teams can reduce the possibility of delay at a cost, preventing it by prevention.
What makes Octalsoft stand out from other platforms is that it constantly learns with new data. With each piece of information, it gets better at trying to pinpoint trends, anomalies, and risks-making it an essential component of conducting long-term clinical trials.
3. Adjustable Risk Metrics and Thresholds
Octalsoft's eClinical suite stands out in providing extreme flexibility in tailoring risk indicators and thresholds. Users can then define specific risk factors appropriate to the nature of their unique trial, be it patient demographics, treatment regimens, or geographic locations. Such customization ensures that appropriate monitoring efforts are truly targeted to the needs of a given trial, thereby curtailing unnecessary effort and making efforts much more efficient.
The platform also facilitates the calibration of the risk metric on the fly as the trial progresses. With more data available, risk thresholds can be progressively refined to reflect the dynamic nature of the study. This means clinical trial teams are always focused on the most relevant risks.
4. Real-Time Alerts and Actionable Insights
One of the strong features of the RBM solution offered by Octalsoft is its real-time alert system. It automatically notifies users about the presence of risks in such areas as disagreement on data or deviations from study protocols. Risks can be prioritized either by severity or by probability, and different levels of such risks can be customized by the users.
In addition to real-time alerts, the eClinical suite from Octalsoft gives actionable insights into the root causes of problems. With regard to this system, the underlying data is analyzed so that clinical trial teams can understand why this particular risk happened and how to rectify it. At this level, insight is needed for optimal data quality and participant safety while managing the clinical trial.
5. Regulatory Compliance and Audit Trail
Regulatory compliance is impossible with just any RBM platform. Octalsoft's eClinical suite has been validated for compliance with all FDA, EMA, and ICH GCP guidelines in order to ensure clinical trials are performed at the highest standards achievable. The audit trail on the platform allows step-by-step records of every action undertaken within the system, making it easy to demonstrate compliance during regulatory inspections.
This feature of the audit trail tracks every action, change, and update made on the platform. Such transparency helps preserve the integrity of a clinical trial's data and ensures that it is always credible in the eyes of its stakeholders.
6. Cost-Efficiency
The high-light monitoring efforts on areas of high risk directly cuts down the overall cost of running a clinical trial. Traditional approaches for monitoring require multiple man-days and resources to review all data manually; with RBM, only the most critical data points are monitored intensely, and so there are enormous cost savings without compromising on data quality or patient safety.
This early identification of risks also decreases costly delays due to protocol deviations or discrepancies in data from deviations at early stages. With such escalations brought down, Octalsoft's eClinical suite ensures that a trial stays scheduled and in budget.
Conclusion
In the fast-changing world of clinical trials, risk-based monitoring has become the gold standard to ensure the quality of data and participant safety. Foremost a mong robust and feature-rich RBM solutions is the Octalsoft’s eClinical suite which combines advanced analytics, real-time alerts, and customizable risk metrics, to make clinical trial monitoring streamlined.
What makes the difference of Octalsoft for other RBM platforms is the easy integration with other trial management tools, advanced predictive analytics execution capability, and customization for every specific phase for the case of a specific trial. Being a better choice for leading-edge RBM solutions in clinical teams, Octalsoft's eClinical suite offers cost savings, efficiency improvements, and regulatory compliance.
Octalsoft's eClinical suite brings the most reliable platforms to the sponsors of clinical studies, making sure that success envelops their studies with every care possible for the safety of the participants. Want to know more about how Octalsoft’s eClinical suite can help power risk-based monitoring in your next clinical trial? Book a demo with us today!
