MainEDC RBM

MainEDC™ RBM is a Risk-Based Monitoring module within the MainEDC™ EDC and IWRS platform, developed by DM365. It is designed for sponsors, CROs, and clinical research teams seeking to monitor clinical trial data and processes according to a risk-based strategy aligned with ICH GCP E6(R2) guidelines. The module supports a shift from traditional on-site monitoring toward remote and central data monitoring, with the stated goal of reducing monitoring budgets and overall trial costs while maintaining or improving data quality and participant safety.

Clients implementing the RBM approach through MainEDC™ have reported reductions of up to 65% in monitoring budgets and up to 30% in overall clinical trial budgets, alongside improvements in data quality.

Core Principles of Risk-Based Monitoring

• Focus on patient rights and safety, with attention to reducing the risk of unintended side effects.
• Higher data quality through targeted identification of potential problems and protocol deviations in the most risk-prone areas.
• Stricter adherence to study timelines by enabling faster identification of issues that could cause delays.
• Improved risk management, giving researchers and sponsors a clearer understanding of study-associated risks to support more informed decision-making.
• Increased trust in study results among participants, patient communities, and regulatory bodies when high safety and ethical standards are maintained.
• Cost-effectiveness compared to traditional monitoring methods that rely on frequent and costly on-site visits.
• Reduced financial and legal risks for sponsors and investors through structured risk management.

RBM Implementation Process

• The implementation combines a risk-based methodology, a shift from on-site to remote monitoring, central data monitoring, and the development of additional analytical reporting tools.
• Internal business processes are reviewed and reorganised prior to implementation, including finalising a detailed RBM strategy document, step-by-step site working instructions, monitoring plans, and updated internal procedures.
• The approach is developed in accordance with international regulations from the FDA and EMA, as well as prior implementation experience.

Risk Identification and Assessment

• Risks are categorised based on their impact on the safety of research subjects, the integrity and quality of collected data, and the quality of the investigational product.
• Each risk is assessed using three parameters: severity, probability of occurrence, and detectability.
• Based on this assessment, each risk is assigned a priority level, and procedures are defined for reducing the probability of occurrence and mitigating consequences.

Identification of Critical Data

• Critical data is determined in consultation with study biostatisticians, covering safety data for research subjects and data for analysing primary and secondary protocol endpoints.
• An algorithm and format for verifying critical data are established within the data validation plan.
• Trigger events are identified to initiate verification of critical data during the ongoing study.
• Central data monitoring during an active study is treated as an analytics function — distinct from the statistical analysis performed after database lock — with the objective of identifying and correcting issues while the study is still in progress.

Site Health Assessment

• Site assessment parameters are developed based on data entered into MainEDC™, with each parameter assigned a specific weight.
• Assessment procedures are categorised as initial, routine (periodic), or ad hoc (triggered by a specific event).
• During initial assessment, baseline values are established for each parameter at each site.
• When a previously identified risk is realised, an ad hoc check is triggered and the weight of the corresponding parameter is increased.
• Each site is assigned a status based on check results, which determines the mode of operation: the required scale of Source Data Verification (SDV) as a percentage of total data points, the necessity of on-site data re-verification, and the depth of central data monitoring.
• The date of the next check and the priority of the next on-site monitoring visit are set accordingly.

RBM Strategy Definition

• Clinical Research Associates (CRAs) conduct remote verification of a defined set of data for each subject at each site.
• The scope of data to be checked and verified is determined by the current health assessment level of the site.

Measuring RBM Implementation Results

• Duration and cost of conducting the study.
• Level of business process optimisation.
• Quality of the obtained data.
• Changes in the workload of CRAs and investigators.

Pricing and Available Packages

• A basic RBM solution is available at $1,999, including standard site health assessment parameters and 8 hours of technical support.
• The basic package includes any 5 parameters selected from: enrolment rate, screening failure rate, query rate, not answered queries rate, SAE rate, early withdrawal rate, missed visits rate, overdue visits rate, deviation quantity, eCRF completion time, query answer time, screening rate, out-of-window visits rate, and SDV level.
• Additional services include: development of a project-specific RBM strategy ($1,499), SOP review ($999), addition of a custom site health assessment parameter including testing and UAT ($899 per parameter), mentoring on additional solutions (8 hours), and optional training.

MainEDC™ RBM is offered by DM365 and operates within the MainEDC™ platform, which is described as supporting secure data storage and compliance with regulatory requirements. The solution is configurable to project-specific needs, and DM365 can be contacted directly to select an RBM approach suited to a given study.