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Risk Management and RTSM

The revisions in ICH E6 (R2) – Good Clinical Practice has garnered a lot of attention, not least because of the explicit recommendations for the incorporation of a formal risk analysis when planning and executing trials. The starting point for managing risk effectively is adopting a suitable risk analysis and mitigation method, such as risk scoring or failure modes effects analysis. We need to understand what could go wrong (hazard), what happens if it occurs (impact), how likely it is to happen (probability), and how likely we are to realize it has happened (detectability). These methods enable us to look at risk with a more objective eye. Often, the effort reveals unexpected risks or changes our understanding of the risks that should be prioritized. We can think about how to reduce the probability of occurrence or monitor activities to predict and prevent occurrence.

The use of risk management methods has been spreading through the pharmaceutical industry for many years (for example appearing in ICH Q9 – Quality Risk Management in 2005), and the concept itself can and should be appropriately applied to planning and executing all activities. Below, I note some ways we should consider 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 should be applied to the three core elements of the business process – procedures, people, and tools:


The steps to follow that ensure consistent outputs


Staff with the correct skills and training to execute the procedure


Used by people to support or drive execution of the procedure correctly. Can be quality tools such as SOPs and checklists, IT solutions, equipment etc.

Procedures give us operational control as well as a path to implement process improvement. People considerations include ensuring we are hiring the right people in house for the job and having appropriate vendor selection and management of outsourcing strategies. Tools can include the equipment for manufacturing, labeling and storage, as well as the selection of trial management tools such as RTSM. An enterprise or preferred vendor RTSM solution (hosted or on-premises) can provide opportunities to standardize practices that embody the results of your risk mitigation strategy. In the information age, interoperability facilitates integration of information from the various activities in the clinical trial or program, giving real time or near real time visibility into project risk areas such as protocol compliance, inventory movement and storage, and dispensing.

Managing risk at the enterprise level

Often, in mature organizations, institutional practices and structure are inherently designed to manage known risks. In these organizations, a periodic assessment can be used to understand if the risk map has changed. For example, at the enterprise level, some pharmaceutical companies have moved to cold chain products in recent years, as well as products that require associated bulk supplies such as injectors. This has forced transformational change throughout the clinical supplies supply chain from the teams responsible for manufacturing, labeling, 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. For smaller, growing biotech and pharma, risk management is focused on designing practice and structure to reduce risk of failures; but, in principle, the exercise is the same in both settings.

RTSM selection for enterprise is a significant investment, and the following should be considered:

  • Service delivery – can the vendor demonstrate reliable and consistent performance in software and services?
  • Feature-rich systems – when using our supply chain example, can the vendor offering help plan supplies, manage complex treatment packaging strategies in use at your organization, support tracking of storage conditions, and manage and report returns and destruction?
  • Integration – can the vendor demonstrate strong interoperability capabilities with supply chain, trial management, and reporting platforms that support goals for data accessibility and visibility?
  • Continuous improvement – sometimes overlooked, can the vendor demonstrate a commitment to product development and refinement?

Risk management in trial planning

Risk management at the trial or program level starts with protocol design and flows from there. The selection of RTSM tools can be made on a protocol-by-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 provides an implementation process that minimizes risk of missed milestones for release, missed/incorrectly understood requirements, and post-release bugs?
  • Which vendor shows domain knowledge and how to use it in a consultative approach where they actively contribute to risk mitigation in the trial? (i.e. through designing simple and reliable solutions that meet requirements for that specific protocol)
  • Which vendor can demonstrate a scalable process and resourcing models?
  • Change during the trial is to be expected (protocol, supplies strategies, trial sites, countries etc.). How do you ensure the selected vendor and tool(s) provide the best contribution to controlled change management?
  • Which vendor provides monitoring tools that, directly or through integrated reporting, allow you to extract the maximum value for trial oversight from the data captured or generated throughout the trial?

These are just a few of the questions that are raised and discussed in sponsor, CRO, and vendor settings every week. At Bioclinica, we can help you find the right answers to these questions and more. Feel free to reach out to me in an email at


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