As a part of full-service support in clinical trials Smooth Drug Development provides Centralized monitoring services.
Centralized monitoring is a core of risk-based monitoring1 approach. Centralized monitoring is encouraged by FDA and European Medicines.
Centralized monitoring is a process of regular remote collection of data on key indicators of a clinical study, its processing and analysis to identify potentially inconsistent, missing study data. The obtained results can be used to adjust the strategy and study plans for clinical monitoring of research sites.
Before each study clinical operations, biostatisticians and data management teams determine key risk indicators of a clinical trial which will be checked during the study using centralized monitoring. For example,
- % of screen failures
- % of unperformed visits
- Number of AEs per subject at site or study level
- Number of protocol deviations at site or study level
- Number of data queries at site or study level
Centralized monitoring helps to:
- Identify risks to clinical data early on by assessing missing, inconsistent data or unusual distribution of data, protocol deviations
- Assess data trends such as the range, outliers and data variability within and across sites
- Identify systematic or major errors in data collection and reporting
- Analyze site characteristics, poor performance and non-compliance
After performing centralized monitoring, the team has the ability to analyze trends in the study, for example ranges of values, attributability, variability of data within and between sites. The team is able to evaluate the characteristics of sites and performance indicators. Centralized monitoring provides access to cumulative data across sites. Based on the performance indicators it is possible to adjust the frequency and volume of sites monitoring and manage patients’ enrollment.
Centralized monitoring helps streamline trials while alleviating labor-intensive and costly SDVs.Smooth Drug Development performs centralized monitoring in all multicenter trials regardless its size and complexity.
1 FDA’s definition of risk-based monitoring:
RBM – is the adequate mix of strategies including centralized and onsite monitoring practices with the goal of human subject protection and trial integrity
EMA’s definition of risk-based monitoring:
RBM – is an important part of a preventive clinical trial management approach, which aims to identify, assess, control, communicate and review the risks associated with the clinical trial during its life cycle in order to guarantee the protection of trial subjects’ rights, well-being, integrity and safety and the assurance of quality of data and the trial credibility.