Remarque Systems

Achieving ICH E6 (R2) Compliance with Comprehensive RBM Technology

Recent updates to the ICH Guidelines for Good Clinical Practice have put risk-based monitoring in the limelight, and companies are now scrambling to comply with the requirement to develop a systematic, prioritized, risk-based approach to monitoring clinical trials.[1] In today’s competitive landscape, where sponsors and CROs are under increasing pressure to reduce costs while protecting patient safety and maintaining data integrity, this requirement can be daunting.

The shift to risk-based quality management and monitoring can be time-consuming and costly. According to the FDA, sponsors will need approximately 60 hours to put a quality management system in place, and the process can be expensive.[2] Integrating a robust technology solution that addresses risk in all of its layers — operational, safety, and quality — can help smooth the transition to RBM, enabling sponsors to manage risk more efficiently and effectively while minimizing delays and improving safety and quality.

Features of a Comprehensive RBM System

A comprehensive RBM solution should do the following:

  • Identify and log critical processes and data.
  • Assess and characterize risks in context, both at the start of and throughout the course of the study.
  • Generate signals through a combination of drill-down capabilities, algorithms, and intuitive, actionable data visualization.
  • Act on and close risks through built-in workflows and ticketing functionality.
  • Allow for targeted actions to follow up, close, and prevent such signals in the future.
  • Allow for regular and ongoing review and modification.

Truly comprehensive RBM solutions, such as Remarque, offer a dynamic approach to monitoring and managing risk. Not only should the technology offer a way to view risks, it should have the analytical power to provide insights into the relevance of the data for the clinical trial and offer actionable steps that make optimal use of the data, all with a clear audit trail. The system should also work alongside technologies such as electronic data capture and clinical trial management systems to integrate data and signals that might call for a monitor to intervene.

Benefits of Implementing a Comprehensive RBM Approach

Implementation of RBM has the potential to bring clear, measurable benefits in key areas of clinical development:

  • Patient Safety and Data Quality. A comprehensive RBM solution tracks trends and anomalies and makes actionable data available to sponsors and CROs so they can take corrective action.
  • Cost. Next to investigator fees, clinical monitoring is the main driver of trial costs, accounting for an estimated 30 percent of all expenses and more than 60 percent of labor costs. RBM analytics enable sponsors to move away from calendar-based site visits to signal-driven ones, saving time and expense.
  • Timelines. Data cleaning typically adds more than three months to the study timeline. RBM accelerates the timeline through ongoing data evaluation, minimizing the delay from the end of the study to the reporting of study results.
  • Regulatory Compliance. In light of the ICH E6 (R2) guideline, there is an increasing need to provide full traceability and assurance when implementing RRM. A robust RBM system has traceability, assurance, and audit capabilities built in.

To realize the benefits of RBM, technology alone is not enough. Change management related to process and people is also essential. Process comes in the form of a risk-based monitoring plan, and strong commitment at the leadership level — along with staff training — helps ensure that RBM becomes part of the organizational culture.

[1] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Guideline for Good Clinical Practice E6 (R2), November 9, 2016. Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf.

[2] Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017). Available at https://www.gpo.gov/fdsys/pkg/FR-2017-07-18/html/2017-14999.htm.

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