Clinical trials must be properly monitored by sponsors, not only to protect the participants in the trials but also to ensure trial data integrity for regulatory compliance. Capable of adapting to the level of risk, Risk Based Quality Management (RBQM) can prove highly effective for onsite-monitoring. This is why sponsors believe RBQM is the way to go when monitoring critical data elements as it helps ensure data quality, improve safety and check the rising costs of drug development.

It’s time to bid goodbye to cumbersome practices which drive up drug development expenses and extend project timelines, with teams traveling to all study sites to check and verify all data points, whether critical or non-critical. Monitoring today can be centralized and remote. All submitted data can be remotely verified to identify missing data trends, outliers and even potential protocol deviations without the need for onsite monitoring. With RBQM, it’s easy to identify even unusual distribution of data at any site, high screen failure or withdrawal rates, high levels of eligibility violations and delays in reporting any critical data elements. Integrated solution providers in RBQM help improve monitoring processes, enabling real-time analysis and improvement in overall quality and compliance.

Evolving RBQM Solutions

An effective, cloud-based integrated solution offers sponsors the ability to gain oversight into clinical investigations by integrating with multiple EDC, CTMS, Safety, Healthcare, PV and document management systems (DMS) and by enabling the standardization and storage of data. The solution’s data analytics capabilities should offer sponsors a range of insights into trial data, including predictive analytics with a dashboard for metrics, key performance indicators, key risk indicators, configurable thresholds, triggers, alerts, escalations, and workflows. This will drive proactive risk mitigation and actionable outcomes and enable timely decision-making. It can also enable course correction throughout the monitoring cycle. Sponsors can now enhance patient safety and data quality, as the solution enables effective protocol design, reduces costs, and offers the ability to strategically adjust oversight in proportion to the level of risk.

Automating and Optimizing Monitoring Activities

Trial monitoring accounts for a substantial portion of total study costs in the drug development cycle and sponsors have explored ways to reduce them through better efficiency in study management. This calls for monitoring functionality that goes over and above the central data collection capabilities made possible by EDC and CTMS systems. With the shift toward risk-based monitoring, technology is helping to collect and track critical data elements, with real-time data standardization and analytics to provide timely insights and shorten trial costs and time significantly. The powerful insights into data powered by modern analytical tools and technologies are driving effective and accurate monitoring and risk mitigation. Modified site management is helping to reduce costs by more than 20%, while improving the quality and integrity of the trial by uncovering problems with the data early, identifying potential risks, and ensuring that the staff at the site are adhering to trial protocols.

Monitoring plans should be tailored to protect trial participants and the integrity of trial data, with focus on preventing or mitigating possible sources of error in the conduct, collection, and reporting of critical data and processes. Sponsors must also analyze ongoing data to continuously assess and adjust their monitoring strategies and activities.

Requirements for RBQM Success

When choosing a solution that will support evolving requirements, ensure that it offers you the following capabilities:

• Disparate Data Throughout the Data Lifecycle: The ability to communicate with disparate data sources and integrate, aggregate, and review not just sponsor-specific metadata but also standard metadata, with remote analysis capability, while being flexible and configurable across different data standards, with cross-functional report generation capabilities to offer better visibility through disparate data based on their linkage or dependencies.
• Risk Mitigation Functionality: Mitigate risk through selective source data validation in a seamless, real-time process, identifying discrepancies like missing or fraudulent data, duplicate records, data outliers, and inconsistent data offering increased data quality and integrity.
• Data Standardization: Eliminate all inconsistencies and standardize the data collected for analysis or submission to regulatory authorities. Help identify missing or inconsistent data, data outliers, and potential protocol deviations that may be indicative of systemic or significant errors in data collection and reporting at a site level.
• Process Visibility: Centralized, easy to navigate monitoring capabilities, that offer visibility into issues, their status and actions needed to be taken. Reports in different formats like xls, pdf, png, jpg, html, that can be generated by applying appropriate filters like study, site etc., in its report generation interface.
• Content Management Platform: Offers a simplified content development solution with highly organized author and reviewer workflow, and features like reusability, resulting in cost effective and quality content development.
• Innovative Analytics: Solution should offer easy operability and role-based dashboards with data-driven visualizations, statistical reports and scenario modeling, including an analytics dashboard with cross-functional drilldowns to delve deep into the root cause of an issue.
• Compliance: Compliance with different global regulatory standards like 21 CFR part 11 or CSV guidelines by EMA etc.
• Security: Central and highly secured data storage in the cloud, with role-based user access, making it highly reliable and secure.

MaxisIT’s own fit-for-purpose RBQM solution offers all these and much more.

About MaxisIT

At MaxisIT, we clearly understand strategic priorities within clinical R&D, as we implement solutions for improving Clinical Development Portfolios via an integrated platform-based approach. For over 17 years, MaxisIT’s Clinical Trial Oversight System (CTOS) has been synonymous with timely access to study-specific, standardized and aggregated operational, trial, and patient data, enabling efficient trial oversight. MaxisIT’s platform is a purpose-built solution, which helps the Life Sciences industry by empowering business stakeholders. Our solution optimizes the clinical ecosystem; and enables in-time decision support, continuous monitoring and regulatory compliance, and greater operational efficiency at a measurable rate.