Article Blog November 30, 2017

Risk Management: Aligning Automation with Best Practices to Meet ICH E6 (R2) Guidelines

When it comes to meeting ICH E6(R2) guidelines, managing risk is one of the key challenges sponsors face. While sponsors are already well familiar with—and typically have established plans for—risk management, the new addendum spells out some changes.

One example is how sponsors address risk in conjunction with their vendor partners. ICH E6(R2) also calls out the need to apply technology to clinical trial management that have typically been handled manually.

Summary of FDA’s Risk Management Guidelines
In a previous Comprehend webinar, we outlined a number of risk management best practices to help sponsors comply with FDA guidelines risk management guidelines across the following key areas:

A Difference in Perspective
A fundamental element of effective risk management in clinical trials is how well sponsor and CRO partners share information and collaborate on risk activities in the course of a trial. Per the ICH E6(R2) addendum, sponsors are responsible for the work product of CROs and their subcontracted service providers. Further, the addendum stipulates that sponsors implement a quality management system that utilizes risk-based approaches.

The risk management guidelines above apply to sponsors and providers; however, significant improvement is needed across these shared areas of responsibility. According to a recent survey on risk by The Avoca Group1, a wide gap exists between satisfaction levels noted by sponsors and providers. While more than 60% of providers surveyed believe they are doing well in compiling risk-related information in a trial and communicating risk-related information to their sponsors, only 41% of sponsors agreed.

What is causing the gap?
In a recent poll, a large majority of sponsors claimed that their number one ICH E6(R2) compliance concern was proper reporting. In addition, they called out areas where they most needed support, including:

  • Getting real-time insights into study risk
  • Improving data aggregation across systems, including CRO data
  • Defining and implementing relevant KPIs

CROs also have specific issues that must be addressed before the gap can be closed. In a recent benchmark survey2, CROs noted three significant areas of concern:

  • Constantly changing sponsor priorities
  • The need for a risk-based approach to oversight
  • Inability to coordinate real-time data analysis for their sponsors

Four Best Practice Elements of Risk Management
In the Comprehend webinar, we aligned FDA guidelines for risk with best practice advice on how to establish a coordinated and collaborative risk management effort. Using the backdrop of a pharmaceutical case study, we isolated four main elements that were operationalized by the sponsor’s clinical development teams to overcome sponsor-CRO gaps.

The pharmaceutical company was conducting 16 studies, with data coming from three different clinical data systems. Sponsor executives were concerned about site performance, delays in getting information, increasing study complexity and maintaining collaboration and productivity around protocol deviation resolution.

To address these issues, the sponsor deployed a Clinical Intelligence solution from Comprehend that aggregated data from in-house and external systems, providing real-time insights necessary to reduce risk and increase study performance. This technology provided the sponsor with the ability to automate the following best practices:

Risk Assessment
Automatic alerts identified potential risks, which could be prioritized and assigned to the appropriate people for rapid resolution.

Risk Mitigation
In collaboration with its CROs, the sponsor determined ways to avoid risk, which risks were acceptable, and how to assign responsibility to the proper team.

Risk Monitoring & Review
The sponsor and its CROs used real-time data access, analytics related to trends and outliers, and the ability to actually see if studies were in compliance to evaluate their risk standing.

Documentation & Collaboration
The software included built-in visualizations, reporting capabilities, and task management functionality to reduce delays in reporting and communication. This facilitated a true partnership between the sponsor and its CROs.

A Balanced Approach Delivers Results
By combining best practices and automation, this sponsor reduced the time it spent coordinating with its CROs by 40% and brought 95% of its sites within risk thresholds. Working with Comprehend has provided a solid foundation for trusted sponsor-CRO relationships, reduced risk, and improved performance and compliance.

To view an Infographic of “The Four Best Practice Elements of Risk Management,” click here.

Click here to listen to the webinar.

Editor’s Note: Since this blog was first posted in 2017, we’ve made it even easier to manage oversight with the Comprehend Oversight Scorecard. This powerful new data visualization and analytics solution delivers a quick, comprehensive overview of risk, quality, and performance Indicators across a single study or an entire portfolio. With the Oversight Scorecard, users can monitor scores for sites, studies, countries, and vendors—based on pre-selected metrics—to make better, faster decisions.

Download the Oversight Scorecard datasheet

  1. The 2017 Avoca Industry Report, Using Technology in a Risk-Based Environment,” November 2017
  2. CRO Market Benchmark Survey Report,” September 2017

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