Elevate your trial with Superior Risk-Based Monitoring

Optimized Risk Based Monitoring for Enhanced Efficiency

At Navitas Life Sciences, our Risk-Based Monitoring (RBM) approach is meticulously designed to enhance clinical trial oversight by identifying and mitigating key risks. Through advanced digital tools and near real-time data utilization, we focus monitoring efforts on critical data points and processes, significantly streamlining site operations and boosting overall study efficiency. This proactive risk management strategy ensures early detection and resolution of issues, maintaining the accuracy and reliability of your trial data from start to finish. By moving away from 100% source data verification, our RBM methodology fulfils regulatory requirements while optimizing resource allocation, allowing study teams to concentrate on high-value tasks.

Strategic Partner for Risk-Based Monitoring

Our risk based monitoring in clinical trials are tailored to the specific risk profiles of individual studies, integrating a blend of centralized and on-site monitoring activities. Leveraging our proprietary OneClinical platform, we provide near real-time project status updates across multiple domains, ensuring transparent and efficient management of your clinical trials. This integrated approach allows us to deliver comprehensive oversight while maintaining the flexibility to adapt to the unique requirements of each trial. Powering possibilities by prioritizing monitoring efforts based on potential risks, to improve data quality, enhance patient safety, and ultimately accelerate the approval process for Investigational Medicinal Products (IMPs).

Risk-Based Quality Management (RBQM)

A risk-based approach to quality management emphasizes critical data and processes to ensure the safety of subjects/patients and the reliability of data.

Key Highlights for Implementing Risk-Based Approaches

Consolidating Risk Plans: All identified risks should be documented in a cohesive risk plan, integrating existing standard operating procedures.
Multi-Level Risk Identification: It's essential to consider risks from various perspectives, including site, subject, and trial levels.
Traditional Tracking Enhanced: Historical site risks such as aging queries, protocol deviations, adverse events, and serious adverse events are now tracked with a focus on criticality.
Critical Data/Processes: Identifying and tracking subject risks related to the protocol. Use of historical data and experience can streamline this process.
Cross-Functional Review: Involving operational leads from various project roles, including risk based medical review, risk based data management and risk-based monitoring, ensures comprehensive identification and review of critical data.
Quality Tolerance Limits (QTLs): QTLs are crucial for trial endpoint analysis. Identifying QTLs, including for specific therapeutic areas will benefit trial success.
Proactive Risk Management: Identifying and acting upon risks is crucial for maintaining data integrity.

Our Risk based monitoring plan allows customised risk assessment and high-quality data. Our support includes:

On-Demand Webinar

Technology Enabled Centralized Data Surveillance in Risk Based Monitoring

Find out about remote data collection, centralized monitoring, RBM, and Successful RBM Execution and Harmonization

Presentation

Centralized Medical Data Review at the core of Risk Based Monitoring – the path to success

Explore the Risk Based Monitoring (RBM), Centralized, Medical Data Review (MDR), MDR Thresholds and a case study.

ARTICLE

How Biostatisticians Use advances in Technology to Reshape Risk Based Monitoring

Published in: PHUSE Global
Get insights on risk-based monitoring, need for Statisticians and Programmers, and how Statistical Interpretations for risk help improve efficiencies.