Critical to Quality Factors and Vendor Oversight

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Published: 2024/03/06 By: Tom Lazenby

A Systematic Redirection Towards Proactive Management

Integrating risk-based quality management, and identifying and managing critical to quality factors has become a core activity of successful trial delivery.

If you’re part of a clinical trial team or a clinical trial Sponsor organisation, you’re likely aware of the challenges and problems that accompany the requirements of vendor management and oversight.

In this post, I’m covering the transformation towards proactive vendor management and oversight in clinical trials. Specifically, the application of risk-based quality management and critical to quality factors in this domain.

We will also discuss applications of a data-driven, targeted risk management approach that emphasises how the identification, accountability, and review of these aspects can vastly improve the overall quality and delivery of clinical trials.

The Age-Old Problems with Vendor Oversight

Vendor oversight in clinical trials has typically been burdened with significant impacts on study quality issues. This includes delays due to rework required by vendors, to burdensome preventable issues.

These factors can often lead to a negative impact on study milestones, costs and even regulatory submission quality.

To manage these issues, the trial Sponsor usually responds in a reactive manner. Remedial activities include extensive reviews and rectifying of the work delivered by the vendors, which can lead to substantial delays in the trial timeline.

They also deal with regulatory authorities, addressing and correcting submission quality issues or inspection findings that arise due to these vendor-induced setbacks, adding further to the burden and potentially jeopardising the approval of the product.

Dealing with problems as they occur, is costly and inefficient. It delays trials, increases administrative burden, and compromises the overall integrity of the study.

In an era where regulatory agencies are increasingly focused on the fundamentals of Quality by Design and Risk Based Quality Management in clinical trials, a reactive approach is no longer acceptable.

The Power of Proactivity in Vendor Oversight

Sponsors must shift from reactive to proactive, using a risk-based quality management strategy. Risk-Based Quality Management (RBQM) is a holistic approach focusing on the early identification and mitigation of risks, ensuring data integrity and patient safety.

The process begins with the identification of Critical to Quality Factors (CTQFs) – aspects of the clinical trial that have a direct impact on patient safety and the reliability of trial results. These CTQFs must be identified in the protocol design stage and form the basis for the proactive risk management plan.

In application to the oversight of vendor activities Sponsors can reduce the potential of costly and time-consuming issues down the line. And by identifying Critical to Quality Factors at the protocol design stage, Sponsors can align vendor activities with these critical aspects of the study.

As clinical trial teams and Sponsor organisations, the onus is on you to deliver these new ways of working. Through proactive risk management and a data-driven approach, we can ensure that clinical trials are conducted with the highest standards of quality and integrity.

Quality by Design: The Way Forward

A proactive approach to vendor oversight, applying the principles of RBQM, can become a core component of the Quality by Design (QbD) approach to clinical trials. This approach emphasises the importance of designing quality into the trial from the beginning, rather than trying to ‘inspect’ quality in at later stages.

A proactive, risk-based approach to vendor oversight minimises preventable issues and reduces rework, and results in trials that are more efficient, cost-effective, and compliant with regulatory expectations.

It contributes to better study quality, enhancing the credibility of the data and supporting regulatory submission quality.

Remember, vendor oversight is not just a regulatory requirement; it’s a strategic imperative that has a direct impact on the success of your clinical trials.

Harnessing Critical to Quality Factors for Enhanced Vendor Oversight

Once CTQFs are identified, the next step is to integrate these into a data-driven approach to risk management.

This targeted risk management approach—integral for effective vendor oversight—is underpinned by the core principles of identification, prioritisation, accountability, and review.


Pinpointing potential risks early, to enable pre-emptive mitigation strategies that reduce the likelihood of delays or quality issues linked to vendor activities.


Assess risks based on their potential impact on CTQFs, enabling more efficient allocation of resources to mitigate the most critical risks to the study that are related to vendor activities.


Assign ownership of each identified risk, especially those tied to CTQFs, ensuring effective execution of mitigation strategies and preventing oversight gaps in vendor-related risks.


Regular review of risks and associated mitigation strategies, especially those concerning CTQFs and vendor performance, maintaining the risk management strategy throughout the trial.

Embracing Proactive Vendor Oversight for CTQFs: A Step-By-Step Guide

Transitioning to proactive vendor oversight, for activities impacting critical to quality factors, can be challenging, however with a structured approach, it becomes manageable.

Here is a step-by-step guide to help you navigate this journey:

Step 1: Understand your vendors

Begin by thoroughly understanding your vendors. This understanding includes not only who they are but also their capabilities, particularly in tasks affecting CTQFs. What is their track record in ensuring quality in these critical areas?

Comprehensive knowledge of your vendors allows you to identify potential risks and implement mitigation strategies to address them.

Step 2: Establish clear expectations

These expectations should emphasise the importance of CTQFs.

  • What standards must be maintained to ensure these factors are not compromised?
  • Which processes are contribute to the CTQF?
  • What timelines need to be followed?

By defining expectations clearly, you confirm that your vendors align with your priorities and commit to a RBQM strategy.

Step 3: Implement a robust, data-driven monitoring system

Proactive oversight of vendor activities impacting CTQFs requires a robust and data-driven monitoring system. This should enable you to track vendor performance against CTQFs, identify potential deviations early, and take immediate action to mitigate risks.

Utilising a data-driven system, you gain the insights necessary to manage your vendors effectively, particularly around these critical areas.

Step 4: Foster open communication

Regular check-ins, status updates, and feedback sessions focused on CTQF performance facilitates identification of any potential issues. By addressing issues promptly, you can prevent them from escalating and impacting the quality of your clinical trials.

Step 5: Regularly review and revise your strategy

When reviewing your strategy you must evaluate its effectiveness, particularly around maintaining oversight of vendor associated CTQFs, make revisions when gaps are identified.

Continuous improvement in vendor management practices will ensure your clinical trials meet the highest quality standards.

Wrapping Up: Proactivity as the Key to Quality

As clinical trial teams and sponsor organisations, you need to embrace a proactive, data-driven approach to vendor oversight and risk management.

Focusing on CTQF identification, prioritisation, accountability, and review, you can ensure that trials are conducted with a risk-based approach to improving quality, efficiency, and integrity.

Remember, proactive vendor oversight isn’t about avoiding problems; it’s about creating a more efficient, and more reliable clinical trial process. Prioritise quality by design and put the power of proactivity to work in clinical trials.

Tom Lazenby

Tom is the Founder and CEO of Mayet. Using his experience in streamlining operations and driving innovation in clinical research, Tom is dedicated to enhancing the efficiency, cost-effectiveness, and risk mitigation strategies for vendor management and oversight.

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