Monitoring is one of the key elements of an integrated approach to ensuring high-quality clinical trial data and proper subject protection. Types (e.g. on-site monitoring, centralized monitoring), intensity, frequency and scope of monitoring activities for a given trial are determined and agreed upon with a sponsor prior to the trial initiation, based on its objectives, design and complexity. These monitoring requirements are reflected in a monitoring plan.
Adaptive monitoring approach
Nowadays clinical trials and even non-interventional studies are so different in design, goals, complexity, scope and scale that no single methodology of monitoring can fit them all. Risk-based Monitoring is a customized, quality- and risk-based approach that focuses on the parameters, which are critical for a specific study. It is a mix of centralized and on-site monitoring activities providing a cost- and time-effective way to ensure patient safety, proper quality of a study conduct and study data integrity.
In 2013 Food and Drug Administration (FDA) issued “Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring”, and the European Medicines Agency (EMA) released “Reflection paper on risk based quality management in clinical trials”. These guidelines provide the regulatory perspective and rationale for risk-based monitoring strategies, but they do not mandate specific implementation methods.
Our contract research organization can suggest its local and international clients unique proposition of well-balanced customized risk-based monitoring solutions for their local clinical trials and non-interventional studies. Combination of in-house Data Management, Programming, Biostatistics and Monitoring resources enables us to create strategies of risk-based monitoring which allow real-time proactive study risk assessment. Real-time e-CRF data collection and analysis provides basis for early detection of protocol deviations, adverse events, missing/inconsistent data, other site-specific issues, understanding of patient data trends.
Based on the needs of our customers we can:
- Develop study-specific Key Risk Indicators (KRIs) to trigger fast detection and interpretation / further escalation of risk signals
- Develop study-specific Monitoring Plan tailored to the identified study-specific risks and based on the monitoring strategy selected
- Select study sites taking in account quality of their performance in previous studies with ALMEDIS
- Perform in a real time mode in-house central/remote monitoring of study data
- Conduct central analysis of site performance/compliance
- Adjust quantity, focus and timing of contacts with sites and on-site monitoring visits based on centralized monitoring results to ensure proper site performance and data quality
- Develop and implement corrective/follow-up actions based on the monitoring findings in order to ensure patient protection and data integrity
Risk-based Monitoring approach offered by ALMEDIS to our clients implies significant quality and productivity advantages along with potential cost reduction.