1 Aug 2019 Blog
Covering the bases for effective Risk Based Monitoring

Post FDA’s final guidance on Risk Based Monitoring, Industry is transitioning from routine visits to clinical sites and 100% Source Data Verification to risk-based approaches to monitoring, focusing more on critical data elements by practicing Centralized Monitoring; relying more on technological advancements thus reducing trial cost and time significantly. The industry needs an out-of-the-box end to end solution that will cover all the bases for efficient risk based monitoring allowing business to stay agile and lean while making better and informed business decisions that will allow them to achieve faster and quality clinical drug development compliant to regulatory and assured cost savings

Data Integration

As technology is playing vital role in data collection during clinical trial conduction, multiple data sources like EDC, CTMS, PV, IVRS needs to be handled by sponsor. Before applying analytics on the data it is of utmost importance to place all data at single place. MaxisIT ’s unique data integration capability enables tool to communicate with disparate data sources. As integration is metadata driven it is highly configurable to sponsor specific metadata as well as standard metadata.

Source Data Validation (SDV)

Risk based monitoring emphasizes on selective source data validation in place of onsite 100% source data validation. Our solution offers seamless, real time data validation to extract discrepancies like missing data, duplicate records, data outliers, and inconsistent data. SDV engine also enables users to identify data fraudulence. This level of data validation increases data integrity and quality.

Data Standardization

Data standardization is the first step to ensure that your data is able to be used for analysis and shared across the regulatory. This establishes trustworthy data for use by other applications. Ideally, such standardization should be performed during data entry. If it is not done a comprehensive back end process is necessary to eliminate any inconsistencies in the data. Our standardization capability provides most comprehensive data standardization and transformations across the standards. Being a Metadata driven process it is flexible and configurable across different data standards. Its drag and drop utility makes data standardization easiest ever.

Analytics and Reporting

Effective risk based monitoring can be achieved using different statistics on disparate data related to ongoing trials. Many analytical tools are focusing their efforts on developing RBM oriented analytical engines with user friendly dashboards. Statistics being a functional entity limited to specific user group, configuration of complex statistical reports is never been a welcome step for end user. Data aggregation is imperative while handling disparate data for analytics. Our solutions provide metadata driven data aggregation which enables complex data analytics easier for user. It enables user to have cross functional report generation and better visibility through different data having linkage or dependencies.

MaxisIT ’s innovative analytics tool offers most user friendly operability and role based dashboard allowing users to have multiple reports like data driven visualizations, statistical reports and scenario modeling. Our analytics dashboard provides unique functionality of cross-functional drilldowns. Drilldown functionality allows user to navigate from one report to multiple another reports to understand depth of data and analyze root cause of issue. Similarly our unique entity of scenario modeling leverages understanding of complex cross-functional correlations and enables user to understand complex issue origins.

Monitoring Issue and Risk Management

Management of risks and issues emerged during central and onsite monitoring needs to be handled efficiently for faster resolution. Knowing the risks during monitoring execution and assessing the issues derived from central and onsite monitoring is centralized in our solution to allow the user to have easier navigation through monitoring interfaces and better visibility of all issues, action, and status with multiple levels of filters. User is able to generate monitoring reports based on the study, site, or other attributes by applying filters in our monitoring report generation interfaces. It also allows input of monitoring activities for onsite monitoring which updates central issue log. Our risk and issue log allows users to have an overview of complete status report and audit trails for all issues occurred during the study. All the reports generated are exportable in different formats like xls, pdf, png, jpg, html depending upon the report types. Trial conduction also contains a large amount of content management in form of multiple documents and forms. Our content management platform gives users a simplified content development solution where content development is highly organized with author reviewer workflow and features like reusability, resulting in cost-effective and quality content development.

Regulatory Compliance

MaxisIT ’s solution is highly compliant to different global regulatory standards like 21 CFR part 11 or CSV guidelines by EMA etc. Central and highly secured data storage adds to the completeness of the solution where complete organizational usability of solution is through its single sign-on, role-based user access facilities making it a highly reliable, scalable and complete solution for RBM.


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”.

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