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Article Blog November 30, 2017 5 minute read

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

One of the challenges in meeting the ICH E6 (R2) guidelines involves managing risk. While this is an area that Sponsors are already well familiar with, and typically have established plans for, the new addendum spells out some particular changes. One example is the way that risk needs to be addressed by Sponsors in conjunction with their vendor partners. As well, the addendum calls out the need to apply technology to the previous paper processes of clinical trial management; the area of risk management is not immune to this directive.

Summary of FDA’s Risk Management Guidelines

In a previous Comprehend webinar, a number of Risk Management Best Practices were defined in order to meet the guidelines proposed by this addendum. These Best Practices were described as being able to align the FDA risk management guidelines with four elements on which Sponsors can focus to put the guidelines into play. In summary, the FDA calls out 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 their CRO’s work product, and this includes accountabilities over CROs’ subcontracted service providers. Further, the addendum stipulates that Sponsors implement a quality management system that utilizes risk-based approaches. The ICH guidelines above apply to both Sponsor and provider; however, there is yet to be noted a significant improvement in this shared area of responsibility. According to a recent survey on risk by The Avoca Group1, there is a wide gap between levels of satisfaction noted by Sponsors versus their Providers. While more than 60% of Providers surveyed believe they are doing well in compiling risk-related information in a trial, and in communicating risk-related information to their Sponsors, only 41% of Sponsors agreed that their Providers were doing well in these areas.


What is causing the gap?

In a recent poll of Sponsors regarding their preparedness to manage risk, a large majority claimed that their number one concern with meeting the ICH E6 (R2) addendum was maintaining proper reporting from a risk-based approach. In addition, they called out the areas where they most need support, including:

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

CROs, as well, have their specific issues in being able to close the gap. From a recent benchmark survey of CROs2, there were three significant areas of concern they called out:

  •      Constantly changing priorities from their Sponsors in the course of a trial
  •      Need for a risk-based approach to assist with oversight for their Sponsors
  •      Inability to coordinate real-time data analysis for their Sponsors when asked

Overcoming the Sponsor-CRO Gap with Four Best Practice Elements of Risk Management

In the Comprehend webinar, the FDA guidelines for risk were aligned with best practice advice on how to begin to establish a coordinated and collaborative risk management effort between Sponsors and Vendors. Using the backdrop of a case study of a pharmaceutical company that employed these best practices, the webinar isolated four main elements that were operationalized by the Sponsor’s clinical development teams to overcome the Sponsor-CRO gaps.

The pharmaceutical had 16 studies with data coming from 3 clinical data systems. They were concerned about risk from issues across disparate sites as well as delays in getting information on performance across inhouse and CRO trials. In addition, increasing complexity of their studies and portfolios – and maintaining team collaboration and productivity internally and with their CROs in resolving protocol deviations – introduced risk.

They deployed a Clinical Intelligence solution from Comprehend that, with critically important real-time data aggregation, was able to combine data from both inhouse and external systems to provide the insights and status they needed to see across their trials. This technology provided the Sponsor with the ability to automate the following Best Practice Risk Elements:


Risk Assessment

The Sponsor addressed both Risk Identification and Risk Evaluation. Their risk assessment included identifying potential risks, categorizing them as to severity, and classifying potential outcomes.

Risk Mitigation

In collaboration with their CROs, the Sponsor defined the mitigation actions they needed to address, such as how to avoid risk, how they would need to transfer responsibility to a different operational entity if the risk didn’t apply to their clinical team, and which risks were acceptable or not.

Risk Monitoring & Review

The Sponsor applied technology, such as real-time access to data, information on trends and outliers, and the ability to actually see if they were in compliance, in order to see and evaluate their risk standing. Since they were concerned about protocol deviations, this was a top area of focus for them. The technology enabled their CROs to see the same issues at sites and across trials to improve their ability to coordinate efforts to resolve errors.

Documentation & Collaboration

The software included built-in visualizations, reporting and task management to avoid long delays in data management reporting and email/phone traffic to communicate status and resolve issues. This significantly reduced the time and effort in sharing information as well as supported a true partnership relationship between the Sponsor and its CROs.

A Balanced Approach Delivers Results

By combining Best Practices and automation, this Sponsor was able to reduce the time it spent coordinating with its CRO by 40%. It reduced meeting time, rework and was able to bring 95% of its sites within risk thresholds.  It has established the foundation of a trusting and collaborative relationship with its CROs using a framework that works for both the Sponsor and its CROs.

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

Click here to listen to the webinar.

  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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