Daily Archives: April 18, 2017

Risk Management At Different Levels

The revisions in ICH E6 (R2): Good Clinical Practice have earned a lot of attention, not because of the recommendations for the incorporation of a formal risk analysis when planning and executing trials. The starting point to manage risk effectively is adopting a suitable risk analysis and mitigation method, such as risk scoring or failure modes effects analysis. We must understand what could go wrong, what happens if it occurs, how likely it is to happen and how likely we are to detect it happening.

These methods enable to view risk with a more objective eye. Often, the effort reveals unexpected risks or changes the understanding of the risks that must be prioritized.

The use of risk management methods is popular in pharmaceutical industry for many years, and the concept itself could and should be applied to planning and executing all activities. Below, we note some ways that must be considered during managing risk at the enterprise and clinical trial execution levels in the selection and use of a randomization and trial supply management solution (RTSM).

Analyzing risk in business processes

Risk analysis must be applied to the 3 core elements of the business process mentioned below:

Procedure Helps follow to ensure consistent outputs
People Include correct skills and training to execute the procedure
Tools Used to support or drive execution of a procedure correctly.

Procedures give operational control as well. People considerations include hiring the right people in house for the job and having appropriate vendor selection and management of outsourcing strategies. Tools could include the equipment for manufacturing, labelling and storage, as well as the selection of trial management tools like RTSM. A preferred vendor RTSM solution could provide opportunities to standardize practices that cause the results of your risk mitigation strategy.

Managing risk at enterprise level

Often, in big organizations, institutional practices and structure are inherently created to manage risks. In such organizations, a periodic assessment could be used to understand if the risk map changed. E.g., at the enterprise level, some pharma companies have moved to cold chain products in recent years, as well as products that require associated bulk supplies such as injectors. This has triggered transformational change in the clinical supplies supply chain from the teams responsible for manufacturing, labelling, and distributing to those responsible for monitoring storage and accountability of study drug at clinical trial sites, relating directly to the effective use of RTSM systems.

On RTSM selection for enterprise the following must be considered:

  • Service delivery
  • Feature-rich systems
  • Integration
  • Continuous improvement

Risk management in trial planning

This level starts with protocol design and continues from there. The selection of RTSM tools could be made on a gradual and systematic protocol basis, but this demonstrates how the planning of trial execution should inform our risk analysis for tool selection and implementation. Questions here include:

  • Which vendor gives an implementation process that minimizes risks of missed milestones for release, incorrectly understood needs, and post-release errors?
  • Which vendor has domain knowledge and how to use it in a good approach where they actively contribute to risk mitigation in the trial?
  • Which vendor could demonstrate a scalable process and models?
  • Change during a trial to be expected.
  • Which vendor offers monitoring tools that, allows you to get the maximum value for trial oversight from the data captured or generated throughout a trial?

These are only a few of the questions that are raised and discussed in sponsor, Contract Research Organisation, and vendor settings weekly.

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