Technology Considerations for Successful Risk-Based Monitoring

ARITHMOS is participating in this year’s ePharma Day series across Europe which highlights the importance of risk-based monitoring for clinical trial operational efficiency. Technology plays an important role in successful risk-based monitoring practices in order to conduct 100% source data validation (SDV) at every investigational site. How can technology transition from “common” processes to a RBM approach?

Image_Feb_VitalSync500-466x270Risk-based monitoring (RBM) of clinical trials is an approach that combines on-site monitoring along with centralized remote monitoring by coordinating centers. Based on risk assessments about how the clinical information is captured and protocol is designed, risk-based monitoring activities can be proactively supported by the usage of reporting tools.

The FDA and EMA issue guidelines encourage the use of electronic systems and strategies to identify and prevent risk factors for the quality of data, patient safety and trial integrity.

Electronic Data Capture is an essential part of a RBM technology strategy since it captures data in real time. EDC allows Investigators to capture and monitor site activity remotely, however EDC only captures part of the picture. The EDC system itself captures data and determines which data needs to be verified and analyzed. Although most EDC systems provide built-in reports to support data management activities, other metrics and information which are needed to verify the risk-based approach are not provided to final users. Key information that might not be provided by the EDC system include:

  • Site information to get recruitment activities at the site level
  • Subject status: information about the screening status, screen failure, enrollment etc
  • eCRF status: how many eCRFs have been completed and/or verified?

A risk-based monitoring approach technology strategy should also include analytical business intelligence tools. By using a business intelligence tool to query the EDC database, reports can be designed depending on the targeted audience involved in the trial review including project and data managers, site staff, clinical monitors and safety staff. Reports with centralized monitoring metrics that assess site activity, including recruitment, CRF completion and DCF resolution, can be easily made available for quick analysis and decision-making. Clinical data visualization and analysis is especially important to aggregate data across multiple systems and even multiple studies.

Data Visualization tools now make it possible to collect data from multiple sources, even disparate databases, and display the data in a structured format for all members of the clinical team. An added value is the ability to drill-down data and click-through multiple levels of details to aid in analysis. Tools available today are generally cloud-based which means Sponsors avoid the technology hassle of HTML or plug-ins and enjoy the convenience of data “on the go”.

The intangible benefits of analytical tools for risk-based monitoring are apparent, especially the ability to create ad hoc reports on site information, safety and efficacy, drug supply and patient management. The return on investment from the implementation of these tools is the amount of time saved by being able to access and analyze data immediately and using the data to identify and fix problems.

ARITHMOS’ Gianluigi Albertini will be presenting at the ePharma Day series on “Business Intelligence: Analysis of metrics and effective technology supporting Risk based monitoring in clinical trials”. ePharma Day 2014 focuses on Risk Based Monitoring in Clinical Trials and discusses the importance of developing an overall risk assessment plan, better tools for a holistic and dynamic oversight of site activity and the critical items Auditors will consider for guaranteeing GCP compliance. The first two ePharma Day events are scheduled for 27th of May in Milan, Italy and 26th of June in Frankfurt, Germany.  



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