These are the real results of implementing a risk-based approach by our clients. You will be able
to significantly reduce the time and costs of research, minimize the risk of errors, and improve
data quality. The MainEDC™ system ensures secure information storage and compliance with
all regulatory requirements.
We support the risk-based approach in clinical research described in the ICH GCP E6(R2)
guidelines – fewer resources while improving the quality of clinical trials.
RBM pays special attention to protecting the rights and safety of patients. This approach enhances patient safety and reduces the risk of unintended side effects.
Since the main focus is on the most risky areas of the study, RBM promotes more accurate and timely identification of potential problems and protocol deviations. This helps prevent errors and improve data quality.
Focusing on key risks allows for faster and more accurate identification of issues that could delay the study. This helps reduce the time spent identifying and correcting problematic areas and, consequently, prevents delays in the clinical trial timeline.
RBM provides researchers and sponsors with a better understanding of the risks associated with the study. This helps in making more informed decisions and developing risk management strategies
When a study is conducted with high standards of safety and ethics, it influences the perception of the study by participants, potential patients, patient communities, and regulatory bodies. This contributes to increased trust in the study and its results.
A more focused and less on-site dependent approach of RBM can reduce the overall monitoring costs compared to traditional monitoring methods, which require regular and often expensive visits to clinical sites.
Proper risk management reduces potential financial and legal risks for sponsors and investors in the
clinical trial, making the study more attractive for investment
Overall, risk-based monitoring represents a modern and more intelligent approach to monitoring clinical trials, contributing to improved data quality, patient safety, and the efficiency of the research process.
The main goal: to speed up and reduce the cost of the monitoring process while maintaining or improving
the quality of the collected
Therefore, the primary objective was to change the process while maintaining the high level of
The task was addressed based on:
A combined approach was developed:
It is implied that CRAs will conduct remote verification of a specific set of data for each subject at each site. The scope of the data to be checked and verified will depend on the current health assessment level of the site.
Risks are categorized based on their impact on:
Risk assessment is conducted using the following parameters:
As a result, the priority of each risk is determined. Procedures are described for reducing the probability of
risk occurrence and mitigating the consequences.
Prior to implementing RBM (Risk-Based Monitoring) and remote monitoring, the internal processes of the
Client’s company are being revisited. Documents are being finalized, among which are:
The most important factors influencing the list and priority of potential risks in the study are:
After consultation with study biostatisticians, a list of critical data is determined, along with the algorithm and format for their verification within the data validation plan. At this stage, trigger events are additionally identified to initiate the verification of critical data.
There is an opinion, which we do not share, namely: that statistical data processing should not be performed until the completion of the study and database lock. It is necessary to understand the difference between the objectives of statistical analysis of a completed study (according to the SAP) and the objectives of central data monitoring in an ongoing study (according to the Central Monitoring Plan). The latter is more about analytics than analysis, and its result is the opportunity to correct what can still be corrected.
A list of site assessment parameters is jointly developed based on the data entered into MainEDC™, with each parameter assigned a specific weight.
Next, assessment procedures are categorized as:
During the initial assessment process, input values are established for each parameter for each site. In the event of experiencing one or more risks identified earlier, an ad hoc check is conducted. In this case, the weight of the parameter corresponding to the realized risk is also increased.
Depending on the results of the check, each site is assigned a specific status. Subsequently, based on the assigned status and the possibility of remote monitoring, the mode of operation with the site is determined:
Then, the date of the next check and the priority of the on-site monitoring visit are determined.
Contact us now, and together we will select the RBM solution and maneuver that best meets your needs
Our basic RBM solution,
which includes standard site health assessment parameters, is available for just $1999.
Any 5 parameters
Additional services to the basic package:
