Increasing clinical development costs for drugs has been a concern for industry over the years and multidirectional efforts have been made to lower these costs through more efficient study management. Since monitoring accounts for a substantial proportion of the total study costs, major focus is towards lowering the monitoring costs through the analysis of risks involved during a clinical drug development lifecycle.

Significant savings have been claimed through the use of modified site management; centralized and planned source document verification with only essential onsite source data verification emerging out of inconsistencies assessed through centralized risk based monitoring.

Monitoring is an essential element of clinical trials, ensuring quality and integrity of a clinical investigation. Monitoring uncovers potential problems such as data entry errors or missing data, assures that study documentation exists, assesses the familiarity of the site’s staff with the protocol and required procedures, and provides a sense of the overall quality of a site.

Post FDA’s final guidance and EMA reflections on Risk Based Monitoring, Industry is transitioning from routine visits to clinical sites and 100% Source Data Verification to risk-based approaches to monitoring. This helps sponsors to focus on critical data elements by practicing Centralized Monitoring and relying more on technological advancements thus reducing trial cost and time significantly.

Factors like central data collection systems, and real time data standardization and analytics are important to get a sense of the big picture in order to effectively perform risk-based monitoring. EDC and CTMS have made central data collection possible with higher level of data accuracy than that with traditional data collection methods.

Modern analytics tools and technologies are driving the emergence of centralized monitoring because they provide powerful insights into data. Considering the large scales of current clinical trials, accuracy and effectiveness is problematic with on-site monitoring. Large problems go unnoticed when data results are only skimmed through on-site monitoring practices

What do the authorities have to say?

The EMA emphasizes on the identification of potential risks and prioritization should commence at a very early stage in the preparation of a trial, as part of the basic design process. The concerns with trial and protocol design, design of data collection tools/instruments, the design of the monitoring and data management strategies and plans, including the relative role of centralized versus on-site activities and the data quality tolerances, and the design of record keeping for the study should be addressed within the framework of these dimensions, implementing a quality by design approach. Risk assessment and mitigation plans should be appropriately disseminated within the organization, regularly reviewed and updated when new information becomes available.

FDA recommends that each sponsor design a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial. The monitoring plan should identify the various methods intended to be used and the rationale for their use. Monitoring activities should focus on preventing or mitigating important and likely sources of error in the conduct, collection, and reporting of critical data and processes necessary for human subject protection and trial integrity.

Sponsors should prospectively identify critical data and processes, perform a risk assessment to identify and understand the risks that could affect the collection of critical data or the performance of critical processes, and then develop a monitoring plan that focuses on the important and likely risks to critical data and processes. The guidance highlights the importance of documenting the monitoring plan after assessing the project risks and needs. It also recommends that sponsors analyze ongoing data to continuously assess and adjust the monitoring strategy.

This encourage sponsors to adopt strategies that reflect a risk-based monitoring approach using a combination of monitoring strategies and activities. The approach should emphasize focus on centralized monitoring by identifying critical elements and a plan to address data integrity risks. Several initiatives are underway to promote RBM paradigms and different methodologies are being suggested to achieve maximum out of the RBM approach.

MaxisIT has been constantly in pursuit of providing best innovative solutions to divergent requirements of pharmaceutical industry. With unique integrated clinical development platform and analytical capabilities, our solutions have provided sponsors great ease of work enabling them analyze disparate data sources and derive critical decision scenario on the fly. MaxisIT ’s Holistic and Flexible solution architecture offers complete solution for RBM approach in a real sense.

MaxisIT

At MaxisIT, we clearly understand strategic priorities within clinical R&D, and we can resonate that well with our similar experiences of implementing solutions for improving Clinical Development Portfolio via an integrated platform-based approach; which delivers timely access to study specific as well as standardized and aggregated clinical trial operations as well as patient data, allows efficient trial oversight via remote monitoring, statistically assessed controls, data quality management, clinical reviews, and statistical computing. Moreover, it provides capabilities for planned vs. actual trending, optimization, as well as for fraud detection and risk-based monitoring. MaxisIT’s Integrated Technology Platform is a purpose-built solution, which helps Pharmaceutical & Life sciences industry by “Empowering Business Stakeholders with Integrated Computing, and Self-service Dashboards in the strategically externalized enterprise environment with major focus on the core clinical operations data as well as clinical information assets; which allows improved control over externalized, CROs and partners driven, clinical ecosystem; and enable in-time decision support, continuous monitoring over regulatory compliance, and greater operational efficiency at a measurable rate”.