For decades, clinical research trials relied on frequent in-person, on-site monitoring visits and 100 percent verification of the data collected to ensure high-quality clinical study results and to protect human participants.
This traditional approach helped support plenty of scientific and medical breakthroughs and safeguarded many lives, but it was labor-intensive, time-consuming, pricey, and incompatible with the increasingly digitalized and globalized collection of clinical trial data.
With their increased role in medical development, CROs have a responsibility to help clinical research evolve and to support modernized monitoring and reporting practices by adopting risk-based monitoring (RBM), a quality-by-design-driven method that, implemented properly, is proving more efficient, less costly, and more adaptable to technological innovations in healthcare data collection and reporting.
Here are seven ways CROs and their customers will benefit from adopting RBM:
- Quality Clinical Trial Data. Global clinical trials require a greater division of tasks across multiple functional teams, organizations, and geographies. RBM offers the advantages of off-site centralized monitoring. CROs that standardize monitoring and reporting practices using RBM and the technologies that support it will be equipped to provide sponsors, site investigators, and regulators more consistent and accurate data collection and near-real-time reporting without compromising patient safety or data quality. RBM has shown over numerous studies that it can improve the reliability and verifiability of study data.
- Stronger Patient Safety. Advanced predictive analytics built into a centralized RBM technology platform allow CRO teams to identify potential patient safety issues much faster than through traditional, fragmented monitoring and reporting. An RBM program implemented for a study sponsor allows monitors to see issues and trends evolve in near real time at the patient, site, and study levels across multiple data points, timeframes, and graphical views. It also provides a uniform audit and regulatory compliance trail.
- Near-Real-Time Data. Offering sponsors centralized RBM is a competitive advantage because the CRO can offer sponsors near-real-time trial data outputs (as allowed by trial protocol), collected and analyzed through the centralized RBM system. Such ability to act in a more timely fashion can help strengthen sponsor/CRO bonds.
- Better Clinical Efficiency. Centralizing RBM for sponsors has the potential to cuts weeks and months off study length by creating a more efficient, standardized process in which multi-source data is integrated, reviewed, acted on, and reported throughout study processes. This added efficiency allows for study workers to use their time more economically on more pressing priorities to move the study forward to a speedier outcome.
- More Consistent Regulatory Compliance. The U.S. Food and Drug Administration, the European Medicines Agency, the United Kingdom’s Medicines and Health Products Regulatory Agency, and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use all support the adoption of RBM by CROs and others in the clinical research community. The recently implemented ICH E6 (R2) guideline requires those using RBM to provide full traceability and assurance of their efforts. A robust RBM technology platform can provide built-in assurance, traceability, and audit outputs. It also can provide one-stop, centralized access to regulatory-related study records to meet any current and emerging regulatory requirements, including study subject rights-protection records, adverse-event reports, protocol compliance reports, and electronic patient-reported outcome records.
- Bigger Cost Savings. As much as one-third of overall clinical study costs can go to monitoring and reporting. Traditional on-site monitoring visits are a large part of a clinical study budget due to the manpower, time, and travel costs involved, particularly in studies spread across multiple geographies. Robust RBM implemented at scale has the potential to save sponsors conservatively between 25 and 30 percent of the monitoring expense per trial. Centralized remote monitoring and risk-based source document verification help reduce the number of data points clinical research associates must verify against source data on site, reducing workload, wasted time, and unnecessary cost. RBM-generated analytics also inform human monitors when to physically visit a site, reducing the number of unnecessary physical site visits for monitoring.
- Real-Time Data Collection and Predictive Actions. RBM enables CROs to use digital data signals and computer machine learning to act on the future, not just generate reports about the past. The best RBM support platforms include real-time and predictive machine learning technology that mines appropriate RBM datasets in a study to allow managers to see and act on any trending data, even remotely. This capability allows clinical study managers to act on clinical data and developments sooner, more accurately, and more comprehensively than ever before